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Medicare D Fails to Deliver

February 6, 2006 - One month after launch, the Medicare Part D prescription drug program has been plagued with numerous problems that well exceed expected "initial glitches." The issues have been serious enough to force more than twenty states to invoke emergency Medicaid coverage for dual-eligible seniors. House Democrats have written an urgent letter to Congressional leadership demanding reform and the AARP is already crying out for government-negotiated prices to address the program's inadequacies. Why?

Too many patients are not receiving their medications or are being overcharged, while others are still too confused to make an informed decision about enrollment. The result is that only 3.6 million seniors have actually enrolled voluntarily, 15 million short of the CMS projected target.

What alternatives are available for U.S. seniors? Whether in the short term or as a permanent solution, safe and reputable Canadian pharmacies can offer superior savings vs. most Medicare plans for a lot less hassle. "We can be a stand-alone solution or a safety-net for when Medicare drops coverage, either way it's a soft landing," says Ramy Attalla, Director of Communications at ADV-Care.

A Kaiser Family Foundation study found that 25% of eligible seniors -- as many as 7.4 million people -- would find no financial benefit whatsoever by enrolling in Medicare D. As well, an analysis by the House Government Reform Committee concluded that a Canadian option may be cheaper for seniors who spend less than $1,500 or between $3,000 and $6,400 for drugs each year.

The notion of Canadian drugs being an attractive alternative was also reflected in Gov. Tim Kaine's Democratic response to the State of the Union speech last week..."Our seniors were promised that the new federal Medicare drug plan would make it easier and cheaper to obtain their medication. Instead, many are falling victim to the program's poor planning. They find getting their medicine to be more complex, more expensive, and less reliable...Many states, following the lead of Illinois, have set up simple ways to help seniors purchase safe, American-made prescription drugs from other countries at a fraction of the price they would pay here."

Should Medicare Negotiate with Drug Companies

January 23, 2006 - The federal administration’s Medicare prescription drug program could save billions of dollars and possibly eliminate beneficiaries’ co-payments if Medicare negotiated directly with the pharmaceutical industry for drugs rather than through private insurance companies, according to a new report by the Center for Economic and Policy Research (CEPR).

The report, The Savings from an Efficient Medicare Prescription Drug Plan, projects Medicare would earn a surplus of $40 billion over the next seven years if the United States paid the same prices for drugs as countries such as Australia and Canada that negotiate directly with the pharmaceutical industry.

Passed by Congress in November 2003, the Medicare drug bill is a boon for pharmaceutical companies: Congressional Republicans included a provision that prohibits the government from using Medicare’s enormous purchasing power to negotiate significantly lower prices for drugs, which the U.S. Department of Veterans Affairs does on a regular basis.

The new Medicare drug program “costs the government and beneficiaries considerably more than is necessary,” says economist Dean Baker, author of the CEPR report. “If Medicare could negotiate directly with drug companies, it could save the federal and state governments hundred of billions of dollars and cut insurance premiums.”

The potential from direct negotiations with the drug companies are so large the program’s current projected budget would be enough to fully finance the benefit with no contribution from beneficiaries, the report says.

The new report backs up the findings of a November 2005 congressional study that found prescription drugs would cost 80 percent more under the Bush Medicare plan than drugs negotiated by the federal government in other programs and more than 60 percent higher than the prices available to Canadian consumers.

The prescription drug program, which began officially Jan. 1, 2006, has encountered widespread difficulties, especially for the poorest and sickest seniors who were forced to switch from state Medicaid programs to the new Medicare plans. Nearly two-dozen states have intervened, saying they will pay for medications for any low-income senior who is mistakenly rejected.

Medicare Part D: Surgery Required

CINCINNATI--(BUSINESS WIRE)--Dec. 12, 2005--Medicare Part D, the government's new prescription drug program for seniors, seems to have stumbled coming out of the gate. Almost a month into the program, prospective beneficiaries are frustrated and angry over its unnecessary complexity, and doubtful of obtaining any real benefits. Many are choosing to avoid the program altogether.

In most regions Medicare recipients are presented with dozens of plans, each one covering some drugs but not others, with or without discounts for generics. Some offer supplemental insurance to cover the "Donut Hole"; some don't. There are low-premiums or high premiums; co-pay or co-insurance; high-deductibles or no-deductibles: A dizzying mass of confusion for many seniors.

To compound the problem, Medicare's own site, www.medicare.gov has been rife with errors, to the point that any personal analysis done two weeks ago may well no longer be valid. Medicare's online plan finder contained mistakes about the prices of drug plans, the drugs they cover, and the pharmacies in their networks.

This is not to say that the plans will necessarily help: On Nov 22, Rep. Henry Waxman released a report showing that costs for pharmaceuticals under Part D would be roughly 3% higher than buying retail at a discount chain, or 60% higher than buying from a Canadian pharmacy.

The plan seems to have been designed more for the convenience of big corporations than for American seniors. Part D forbids the government from negotiating with drug companies to obtain lower prices, and the plan itself is being handled as a for-profit venture by private insurance companies.

As it stands, Medicare Part D is complicated and wasteful: It badly serves those whom it was supposed to help. An ill-fitting band-aid at best, the plan will require major surgery before it can become a cure.

Are Canadian Pharmacies a Safety Net for Medicare Gaps

Vancouver, Canada (PRWEB via PR Web Direct) September 13, 2005 -– Medicare's new Prescription Drug coverage (Part D) begins in 2006 and American seniors are struggling to assess and understand the complexity of the program and what it means for them. Even professional caregivers find themselves confused and concerned about the gaps in coverage and the high cost of premiums and deductibles. But of particular concern is the now infamous "donut hole" between the initial and catastrophic coverage, where patients must pay for 100% of their prescription costs.

As well, seniors must carefully select a plan that meets their own prescription needs. Each plan can vary in terms of actual drug coverage and cost of premiums. Many seniors fear large annual hikes in the premiums after enrollment and possible reduction of other Medicare benefits. But their greatest concern – plans that do not cover the drugs they take or arbitrary shifts in coverage at the whim of the drug companies. Even with coverage the overall savings may be marginal for some.

Although the new Medicare drug coverage will benefit some patients, there will likely be many that will slip through the cracks or receive only partial coverage.

One way to mitigate Medicare shortfalls is to order prescriptions by mail from Canada. For 5 years, American patients have saved between 30 – 70% on drugs dispensed by licensed Canadian pharmacies and enjoy the convenience of having their medications shipped to their doorstep. Analysis shows that purchasing from a Canadian pharmacy may be an ideal way to shore up the gaps in any prescription coverage including Medicare.

The former executive director of the Canadian International Pharmacy Association, David MacKay, will be touring U.S. communities speaking to seniors, caregivers and advocacy groups about a range of solutions that includes undistorted facts about Canadian pharmacy services. The tour is sponsored by a reputable pharmacy licensed in the province of British Columbia.

MacKay emphasizes that "we don't intend to present the Canadian option as opposition to Medicare but rather as a compliment to it. The needs of each patient are different but the golden rule is that when you are faced with paying for a drug entirely out-of-pocket, Canada is an ideal solution. Therefore, the overall wisest strategy may be to take advantage of both programs."

MacKay says he intends to address the concerns about the new Medicare coverage by demonstrating how savings from Canada can buffer seniors against the program's shortfalls and coverage gaps. "I have talked to thousands of seniors and caregivers and they are confused and dismayed. We plan to show them a balanced menu of solutions to help them make smart choices."

A helpful tool that automatically calculates Medicare drug expenses can be found on the AARP website at http://sites.stockpoint.com/AARP/drugbenefit.asp .

Are You Really Dealing with a Canadian Pharmacy

June 15, 2005 - Cyveillance®, a provider of online risk monitoring and management solutions, this week announced the findings of research done at the request of the U.S. Food and Drug Administration (FDA). The FDA needed to accurately assess the proliferation of online sites that appeared to be Canadian pharmacies offering prescription drugs at a discount. The FDA chose Cyveillance to help locate and quantify online Canadian pharmacy sales and to identify how many of the thousands of sites were potentially fraudulent.

Starting from the entire Internet universe encompassing millions of web sites, Cyveillance analysis discovered approximately 11,000 sites that were designed to appear as Canadian pharmacy sites. Of these sites, only 1,009 sites actually sold prescription products. After further detailed analysis, only 214 of those 1,009 had any registration data indicating a registrant or owner address located in Canada, or exhibited any data suggesting they were hosted by a Canadian Internet Service Provider (ISP). Certain patterns emerged as well from analysis of the fraudulent sites, for example the fact that over half of the sites registered in the United States and dispensing drugs were registered to a single firm. These facts and other actionable data were forwarded to the FDA to support congressional testimony on this controversial issue.

Americans looking to purchase medications from a legitimate Canadian pharmacy should do a little homework before they make a purchase. Is the pharmacy a member of the Canadian International Pharmacy Association? Are they licensed by the College of Pharmacies in their Canadian province? Do they provide an address and phone number at which they can be contacted? These are the questions that potential consumers should investigate before they decide from which internet site they will make their purchase.

Canada Pharmacy is No. 1 Internet Pharmacy

May 5, 2005 - A recent report of the top prescription websites revealed Canada Pharmacy as the top pharmacy website on the internet. The review included all American and Canadian Pharmacy websites.

According to a survey conducted by comScore, Canada Pharmacy ranks as the most popular site to purchase prescription medications. Canada Pharmacy outranked the largest American online drugstores of Drugstore.com, Walgreens and Wal-Mart.

“We are proud to receive this recognition as the industry leaders. More than 500,000 Americans choose Canada Pharmacy as their source to purchase discount prescription medication from Canada, so this is no surprise,” said Mark Catroppa, one of the founders of Canada Pharmacy. “Our success is attributed to our low prescription prices, excellent customer service and our convenient online and phone ordering process.

Catroppa stated; “As the leading Canadian mail order pharmacy, we set the standard under which our industry follows. We were very pleased with the results of this survey.”

Will Canadian Internet Pharmacies Be Outsourcing

February 12, 2005 - There is a very good chance that Canadian internet pharmacies supplying reasonably priced medications to American customers may soon have to begin outsourcing for pharmaceutical supplies.

In November last year, President Bush made a visit to Canada and there was a great deal of speculation that one of the topics of discussion would be about Canada allowing internet pharmacies to supply medications to Americans. While no one knows what went on at these meetings, about one week later, Canada's Health Minister Ujjal Dosanjh announced the government's intentions to crack down on Canadian doctors countersigning or re-writing prescriptions of American doctors thus allowing Canadian pharmacies to fill the prescriptions. About two weeks later it was announced that Bush had decided that it was about time to start allowing American imports of Canadian beef. Since that time, a Canadian doctor was suspended for two years for re-writing prescriptions from American doctors without actually having seen the patients in question.

It may not be too long before Canadian internet pharmacies will be forced to begin outsourcing from other first-world nations like Great Britain, New Zealand and Israel in order to continue supplying their long term customers with reliable medications. Canadian internet pharmacies have a reputation of supplying only approved medications produced in officially licensed facilities but there are a number of other nations that follow the same strict standards practiced in Canada and the U.S.

So, unless the FDA changes its policy of allowing Americans to import a three month supply of their own medications, it appears that there will continue to be a supply of reasonably priced medications available from a number of reliable sources for some time to come.

Canadian Government Rejects Restricting Drug Exports

December 3, 2004 - Following public criticism of a Liberal MP's bill that would have required the Minister of Health to apply U.S. law to Canadians, the Liberal government has announced in the House of Commons that it does not support the bill. Bill C-282 was introduced in November by Liberal MP Wajid Khan (Mississauga-Streetsville). It would have amended the federal Food and Drug Act by requiring export permits for pharmaceuticals. It included an obligation by the Minister of Health to determine whether the export would violate laws in the United States or other recipient countries.

Current U.S. law does not prohibit the importation of medications from Canada, but concern arose from the possibility that the U.S. may move to tighten restrictions on pharmaceuticals from Canada.

The international pharmacy industry employs thousands of Canadians directly and indirectly. Bill C-282 was criticized as a threat to Canadian industry and sovereignty and a sell-out to U.S. drug manufacturers opposed to imports from Canada.

Robert Thibault, the Parliamentary Secretary for the Minister of Health, announced in the House of Commons on December 1, "(I)t is important to highlight that the bill does not have the support of the Minister of Health, the Minister of State for Public Health nor the Minister of International Trade." Thibault also criticized the bill because it "puts on Canada the burden of enforcing the laws of the U.S. and other countries respecting the importation of prescription drugs."

Conservative MP Steven Fletcher (Charleswood-St. James-Assiniboia) noted the Liberals' recent flip-flops on international pharmacy, and cited "the economic benefit of a new industry and the more than 4,000 jobs it carries with it." He added, "On October 31, the Minister of Health told CBC Television, 'I see no evidence of shortages across the country; at least no evidence has been produced to me'. A few days later, the Prime Minister said that his government would not be taking any action to shut down the Internet pharmacy industry. If that is the case and the health minister has seen no evidence of shortages, this bill is contrary to what the government has said publicly."

The Canadian international pharmacy industry employs an estimated 4000 Canadians directly and a much larger number of Canadians indirectly in supporting industries such as Canadian generic drug makers, pharmaceutical wholesalers, website development companies and computer programming firms.

American Seniors Urge Canada
to Ignore Bush on Pharma Exports

November 30, 2004 - In anticipation of President George Bush's visit to Canada, a public interest group offered their gratitude to Canadians for assisting the elderly and poor in America with obtaining affordable prescription drugs along with words of caution regarding their own President's agenda.

"I know that those Americans who cannot afford the exorbitant prices of prescription drugs in the United States, would want to thank the Canadian pharmacies that mail us affordable drugs and the Canadian people for supporting them," said Michael Burgess, Executive Director of the New York State Alliance for Retired Americans, an organization based in Albany New York
that has been referring older New Yorkers to Canadian pharmacies. "Clearly, our own government is under the control of the multinational drug companies and is allowing them to gouge the elderly and the poor. Thankfully, Canadians have been the first people to help us. We are proud to have Canada as our neighbor," he added.

Canadian drug prices are controlled by the government, unlike those in the U.S., where drug companies can make larger profits by charging prices that many patients, especially the elderly, cannot afford.

Mr. Burgess advised, "I fear that President George Bush is bringing the agenda of the multinational pharmaceutical giants with him to Canada and he may try to push their desire to shut down the Canadian pharmacies that help the uninsured in America. We hope that he won't try to do that because in the presidential campaign, he told older Americans that if he was convinced of the safety of re-importation, he would support it."

Both Canadians and Americans should be concerned because, "If George Bush makes your Prime Minister shut down the Canadian pharmacies, lots of Canadians will be out of work and thousands of Americans won't have access to their medications - lots of needy people will suffer but Big Pharma won't. If these pharmacies were to be shut down though, the calls for Canadian pricing levels in the United States by consumer groups will dramatically increase," he added.

Indeed, in the face of saber rattling from the multinational drug companies, Canadian Health Minister Ujjal Dosanjh appears to bowing. During a recent speech at Harvard University he postulated, "If the consequence is that cross-border internet pharmacies don't exist anymore, then that's the consequence." Five days later, a bill (Bill C-282), introduced by Liberal
Member of Parliament Wajid Khan (Mississauga-Streetsville) and apparently intended to restrict severely or eliminate the cross-border pharmaceutical trade, received its first reading in the House of Commons.

The Canadian international pharmacy industry employs an estimated 4000 Canadians directly and a much larger number of Canadians indirectly in supporting industries such as Canadian generic drug makers, pharmaceutical wholesalers, website development companies and computer programming firms. These jobs are threatened by Bill C-282. Canada Post will also lose very significant revenues given that the national postal agency currently delivers more than two and a half million pharmaceutical packages a year to the United States.

Will Canada Shut Down Drug Exports to the U.S.

November 17, 2004 - Last week, Canadian Health Minister Ujjal Dosanjh called practices of the internet pharmacy exporters "unethical" and "unprofessional". The minister indicated that the government is discussing measures to end the cross-border drug trade, including changes to the Food and Drug Act that would prohibit Canadian doctors from writing prescriptions for anyone but Canadians and visitors to Canada. This would effectively end the practice of "co-signing", whereby internet pharmacies pay doctors up to $10 to sign off on each American prescription so that it can be dispensed by a cross-border trader. Without the ability to pay Canadian doctors to "co-sign" prescriptions, internet pharmacies would no longer be able to ship drugs to the U.S.

The Minister was responding to concerns expressed by a number of Canadian lobby groups opposed to the exportation of Canadian pharmaceuticals to the U.S. On October 18, 2004, groups including CARP - Canada's Association for the Fifty-Plus, the Best Medicines Coalition (BMC), the Canadian Treatment Action Council (CTAC), Canadian Pharmacists Association (CPhA), the Coalition for Manitoba Pharmacy and the Manitoba Society of Seniors came together to jointly call for immediate action to stop the exportation of drugs from Canada to the U.S.

Pharmaceutical Executive Supports Canadian Drug Imports

September 24, 2004 - An executive from Pfizer, the world's largest drugmaker, citicized the pharmaceutical drug industry yesterday for resisting legislation that would allow imports of lower costing prescription drugs from Canada and other countries.

The executive, Peter Rost, speaking at a news conference yesterday on Capitol Hill said: "Holding up a vote on importation, stopping good importation bills has a high, high cost not just in money, but in American lives. Every day we delay, Americans die because they cannot afford life-saving drugs."

Rost, who is a vice president of Pfizer involved in the marketing of growth-hormone products, said the federal government could still regulate imports to guarantee their safety if they were concerned. Rost said that European countries have been exporting and importing drugs between themselves for over 20 years and safety has not been a problem..

Rost said that his views on drug importation were personal and did not represent the views of his company.

Fear the Latest Tactic Against Drug Importations

September 1, 2004 - The latest tactic in the war against U.S. seniors having access to less expensive foreigh prescription medications may just work. That tactic is fear. Last month, Lester Crawford, the FDA's acting commissioner, said tampering with prescription drugs imported from Canada could be a way for terrorists to launch an attack on Americans.

He said possible action by terrorists is the most serious of his concerns about the increasing efforts of states and cities to import drugs from Canada to save money. Crawford added that terrorists could try an attack similar to the 1982 Tylenol tampering case, in which seven people died after ingesting cyanide that had been placed in painkiller containers at Chicago stores.

The American Progress Action Fund suggested that Crawford's warning was a way for President Bush's administration to use "the fear of terrorism" to justify opposition to the state of Vermont's recent plan to import Canadian medications and to beat back presidential challenger John Kerry's call on Bush to approve drug imports for senior citizens. The center called the warning a "cynical, baseless and transparent" tactic.

Just this week, the British pharmaceutical giant GlaxoSmithKline began running newspaper ads that question the quality and safety of medications obtained from Canadian websites. Last month the California legislature approved a bill that calls for creating a state-sponsored website to help consumers find and buy prescription drugs from Canada. While the bill is likely to be vetoed by Gov. Arnold Schwarzenegger, many states already provide such information online.

 

The pharmaceutical giants were out in force at the Republican National Convention this week shoring up their position with regard to the importation of less expensive foreign drugs for American patients.

Among the functions they sponsored were two breakfasts, sponsored by Pfizer, for Oregon delegates, a state that has recently sought permission from the federal government to import cheaper medications from Canada. Other events included an afternoon tea, a nomination-night party for the top brass of President Bush's campaign team co-sponsored by AstraZeneca and Bristol-Myers Squibb and a breast-cancer awareness luncheon funded by Novartis Pharmaceuticals.

Vermont Files Suit Against FDA Over Drug Reimportation

August 19, 2004 - The State of Vermont this afternoon formally filed suit against the Food and Drug Administration (FDA) in U.S. District Court in Burlington, Vermont, becoming the first state in the nation to challenge the FDA’s legal arguments for blocking reimportation proposals.

“Vermont will not sit back and watch as the cost of health insurance and prescription drugs continues to rise. Nor are we content to simply ignore the law,” Governor Douglas said. “Real leadership means challenging those laws and policies you oppose, and working within our systems to change them. It is our hope and expectation that Vermont’s leadership will result in a legal precedent that benefits every Vermonter, and every American.”

Governor Douglas acknowledged that the cost of prescription drugs is but one piece of the problem, and reimportation one part of the solution. As he has done many times before, Douglas said he would continue to urge Congress to take immediate action to increase competition among manufacturers, speed the approval of generic drugs, preserve states’ ability to pool their purchases, protect state pharmaceutical programs that may be impacted by the new Medicare law, and review recent increases in the cost of pharmaceuticals.

“Reforming the American pharmaceutical marketplace must be our top priority,” he said. “The ultimate goal is to get the best possible market prices at our pharmacies here at home.”

The complaint argues that the FDA decision was “arbitrary and capricious, and otherwise unreasonable” and in direct violation of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. The MMA requires the federal government to create rules permitting reimportation of prescription drugs by wholesalers, pharmacists, and state benefit programs, and to issue guidance describing the circumstances under which the FDA will grant waivers allowing reimportation for personal use—neither of which the FDA has done.

According to the complaint, Vermont is seeking a court order that will “require prompt adoption of regulations and waiver guidance and appropriate consideration of Vermont’s proposed program.”

Vermont had sought a waiver from the FDA authorizing a pilot drug reimportation plan. The goal of the pilot project was to demonstrate how a plan could be safely implemented, and ultimately serve as a model for other states to implement similar programs.

Douglas and Attorney General William Sorrell agreed the suit was necessary, saying the federal government’s grounds for denying the waiver request are not legitimate.

“Vermont presented a legal and responsible plan to import prescription drugs,” Governor Douglas said at the time of the FDA rejection. “The claims on which they’ve based (the) denial are, in our view, unsubstantiated and we have no choice but to pursue…all legal remedies available.”

After the complaint has been filed with the court and served on the federal government, the federal government has 60 days to respond.

A copy of the complaint is available at: http://www.vermont.gov/governor/priorities/priorities.html

California Sen. Deborah Ortiz Calls for Canadian Drug Imports

August 19, 2004 - Sen. Deborah Ortiz (D-Sacramento) and other advocates called for Gov. Schwarzenegger’s support of SB 1149 after a two-day trip to research the safety of importing prescription drugs to Canada. Dr. Paul Zickler, co-founder of DoctorSolve Canadian pharmacy joined the group as they toured several pharmacies in Manitoba and British Columbia, Canada.

According to Zickler, Canadian pharmacies understand that safety is a concern, and as a result, are proactive and up-front about their security practices.

“Our goal is to educate the public that the efficiency, professionalism and safety of Canadian pharmacies equals, and often exceeds, that of their U.S. counterparts. They offer a safe, affordable alternative to Californians and other consumers that cannot afford full price prescription medications,” says Zickler.

A statement issued by Sen. Ortiz’s office August 4 summarized the group’s findings:
“We found these drugs are safe, available and ready for importation. Now we need Governor Schwarzenegger to back our legislative efforts to provide every Californian who depends on prescription drugs with a legal, affordable and continuous supply.”

Gary Passmore, spokesman for the Congress of California Seniors, adds, “The Canadian pharmacies we visited were reputable. They are closely regulated. They provide the exact same products, from the same sources, in the same kind of sealed packaging as in the U.S. They are shipped to consumers using reliable shippers. And they are safe.”

The safety measures Passmore mentioned include:
•Only manufacturers’ sealed bottles on pharmacy shelves;
•Health Canada drug tracking numbers on all packages, to certify authenticity;
•Licensed pharmacists reviewing patient medical data to refer to Canadian licensed doctors for a second opinion.

The group asked for Gov. Schwarzenegger’s support of SB 1149, a bill that would require California’s Board of Pharmacy to guide consumers to Canadian pharmacies with recognized safe handling and distribution standards, as well as identify foreign pharmacies and suppliers that consumers should avoid.

Kerry to Fully Legalize Canadian Drug Imports if Elected

July 27, 2004 - Democratic presidential hopeful John Kerry has promised to legalize the growing trend by Americans to purchase prescription drugs from Canada as part of a platform that proclaims health care is a "right and not a privilege."

Kerry's platform vows to expand medical coverage to help address the needs of more than 40 million Americans who have no health insurance, including coverage for all the 8.5 million children who have none. For many seniors in America, the price of prescription drugs is a key issue in the 2004 election. And the Kerry campaign pledges to lower costs and open markets to cheaper foreign supplies.

"We will end the disgrace of seniors being forced to choose between meals and medication," says the platform, which delegates will endorse today. "Our seniors are paying too much for prescription drugs, while options abroad are far cheaper and just as safe. We will allow the safe reimportation of drugs from other countries."

Presently, while importing drugs from foreign countries is technically illegal, the Food and Drug Administration (FDA) has been allowing Americans to import up to a three month supply of their own medications either when they make a visit to Canada or order their medications over the internet.

Faced with rising prescription costs, a growing number of Americans, including state and city politicians who have employee-benefits programs, import drugs from Canada, often drugs that were shipped from the United States in the first place.

House of Reps Vote for Canadian Drug Imports

July 14, 2004 - The U.S. House of Representatives yesterday voted to allow U.S. citizens to buy prescription drugs from Canada. The importation provision was part of a bill that passed on a 389-31 vote for $83.1 billion in spending in the next fiscal year for funding of the Agriculture Department and the Food and Drug Administration.

The bill stops the FDA from enforcing its ban on importations of prescription drugs from countries with lower prices.

Nearly 1,000 Lobbyists Employed to Push Medicare Bill

June 23, 2004 - In the final push for Medicare prescription drug legislation, the pharmaceutical industry, HMOs and related interests spent more money and hired more lobbyists in 2003 than ever before, according to a report issued today by Public Citizen.

The pharmaceutical and managed care industries spent a combined $141 million last year, according to Public Citizen’s analysis of newly released federal lobbying disclosure records. Drugmakers and HMOs hired 952 individual lobbyists in 2003 – nearly half of whom had “revolving door” connections to Congress, the White House or the executive branch. That’s nearly 10 lobbyists for every U.S. senator.

“The Medicare Modernization Act, a top priority of President Bush, promises to safeguard industry profits at the expense of America’s taxpayers,” said Frank Clemente, director of Public Citizen’s Congress Watch. “Considering the legion of lobbyists unleashed by pharmaceutical companies, HMOs and allied industry front groups, no wonder taxpayers ended up with a bill tailor-made to serve these special interests instead of senior citizens.”

Since 1997, Public Citizen has conducted an annual study of Washington lobbying by the pharmaceutical industry. Today’s report, The Medicare Drug War, exposes the extent of the drug industry’s latest lobbying barrage. Among its findings:

Both the pharmaceutical and managed care industries relied heavily on lobbyists with “revolving door” connections. In all, 431 lobbyists employed by the drug industry or HMOs – or 45 percent of all their lobbyists – previously worked for the federal government. Among them were 30 ex-U.S. senators and representatives – 18 Republicans and 12 Democrats.

“The revolving door between the White House and K Street has made the Bush administration indistinguishable from the industry,” said Craig Aaron, senior researcher for Public Citizen’s Congress Watch and lead author of the report. “If it wasn’t bad enough that most of the key negotiators working on the Medicare bill were preparing to cash in on K Street as soon as it passed, Bush has brought in more drug industry and HMO insiders to implement and promote this disastrous new law.”

Florida Gets Tough with Storefront Operators

June 19, 2004 - The Florida Department of Health has issued a cease-and-desist order against "storefront" operations in the state offering to facilitate the purchase of cheaper medications from Canada. The storefront operators have been providing their customers with price quotes as well as helping to fill out the paperwork needed to send prescriptions to licensed pharmacists in Canada.

"Individuals who fraudulently practice any type of health care without a valid Florida license commit a crime that puts the health of our citizens and visitors at risk," John Agwunobi, DOH secretary, said in a news release distributed Friday. "Advertising as a licensed health care provider without a valid license is an offense. DOH will continue to expose businesses that fraudulently represent themselves in Florida," the release said.

The order says the 12 companies are not licensed by the DOH or an appropriate regulatory board. Documents contend the companies violated federal laws by advertising in a way that would lead customers to think the services are approved by the State of Florida and Board of Pharmacy.

Although people have been able to order Canadian medications over the internet for years, many people, especially seniors, are not computer or internet "savy" or they have no access to the internet. For such people, these storefront operations have given them the ability to enjoy similar savings. As a result of this action taken by the DOH these people will have little choice but to get computers with internet access if only for the purpose of making their medication orders from Canada.

Canadian Internet Pharmacies as Safe as U.S.

June 19, 2004 - As the demand for and the cost of prescription drugs rise, many consumers have turned to the Internet to purchase them. However, the global nature of the Internet can hinder state and federal efforts to identify and regulate Internet pharmacies to help assure the safety and efficacy of products sold. Recent reports of unapproved and counterfeit drugs sold over the Internet have raised further concerns.

The U.S. Senate's Permanent Subcommittee on Investigations, Committee on Governmental Affairs therefore had asked the Government Accounting Office (GAO) to prepare a report that was filed today entitled Internet Pharmacies: Some Pose Safety Risks for Consumers that examined (1) the extent to which certain drugs can be purchased over the Internet without a prescription; (2) whether the drugs are handled properly, approved by the Food and Drug Administration (FDA), and authentic; and (3) the extent to which Internet pharmacies are reliable in their business practices.

GAO attempted to purchase up to 10 samples of 13 different drugs, each from a different pharmacy Web site, including sites in the United States, Canada, and other foreign countries. GAO assessed the condition of the samples it received and forwarded the samples to their manufacturers to determine whether they were approved by FDA, safe, and authentic. GAO also confirmed the locations of several Internet pharmacies and undertook measures to examine the reliability of their business practices.

GAO obtained most of the prescription drugs it sought from a variety of Internet pharmacy Web sites without providing a prescription. GAO obtained 68 samples of 11 different drugs—each from a different pharmacy Web site in the United States, Canada, or other foreign countries, including Argentina, Costa Rica, Fiji, India, Mexico, Pakistan, Philippines, Spain, Thailand, and Turkey. Five U.S. and all 18 Canadian pharmacy sites from which GAO received samples required a patient-provided prescription, whereas the remaining 24 U.S. and all 21 foreign pharmacy sites outside of Canada provided a prescription based on their own medical questionnaire or had no prescription requirement. Among the drugs GAO obtained without a prescription were those with special safety restrictions and highly addictive narcotic painkillers.

GAO identified several problems associated with the handling, FDA-approval status, and authenticity of the 21 samples received from Internet pharmacies located in foreign countries outside of Canada. Fewer problems were identified among pharmacies in Canada and the United States. None of the foreign pharmacies outside of Canada included dispensing pharmacy labels that provide instructions for use, few included warning information, and 13 displayed other problems associated with the handling of the drugs. For example, 3 samples of a drug that should be shipped in a temperaturecontrolled environment arrived in envelopes without insulation.

Manufacturer testing revealed that most of these drug samples were unapproved for the U.S. market because, for example, the labeling or the facilities in which they were manufactured had not been approved by FDA; however, manufacturers found the chemical composition of all but 4 was comparable to the product GAO ordered. Four samples were determined to be counterfeit products or otherwise not comparable to the product GAO ordered. Similar to the samples received from other foreign pharmacies, manufacturers found most of those from Canada to be unapproved for the U.S. market; however, manufacturers determined that the chemical composition of all drug samples obtained from Canada were comparable to the product GAO ordered.

Some Internet pharmacies were not reliable in their business practices. Most instances identified involved pharmacies outside of the United States and Canada. GAO did not receive six orders for which it had paid. In addition, GAO found questionable entities located at the return addresses on the packaging of several samples, such as private residences. Finally, 14 of the 68 pharmacy Web sites from which GAO obtained samples were found to be under investigation by regulatory agencies for reasons including selling counterfeit drugs and providing prescription drugs where no valid doctorpatient relationship exists. Nine of these were U.S. sites, 1 a Canadian site, and 4 were other foreign Internet pharmacy sites.

For a full copy of the report including the scope and methodology click here.

U.S. Group Encourages Reporting 'Artificial Shortages' Created by U.S. Drug Companies

April 12, 2004 - Canadian health care consumers are being encouraged by a nonprofit organization in the United States to help document cases where they are unable to get prescription medications due to supply cutbacks by drug companies seeking to discourage U.S. citizens from buying lower-priced Canadian drugs. The request was made today by Results for America , which on November 25, 2003 launched a powerful, consumer-friendly "Canadian Drug Savings Calculator" that consumers have used so far to calculate more than $32 million in possible savings on prescription medications.

Civil Society Institute President Pam Solo said: "It is appalling for us to contemplate a scenario under which U.S. drug companies create artificial shortages of lifesaving medicines in another country in the hopes of drying up the supply of lower-priced medications for American citizens. This approach hurts Canadian consumers. It hurts U.S. consumers. We want to make sure that drug companies are held accountable for any potentially life-endangering situations they may be creating."

Canadian consumers who find that they cannot fill their prescriptions due to sudden shortages of key medications are encouraged to go to http://www.resultsforamerica.org/health/medmail.php and use the form on that Web page. Results For America will collect instances of any reported shortages and report it to Canadian authorities and the news media.

Results for America advised that Canadian consumers of the most popular medications in the U.S. -- Accupril, Actosm, Advair Disku, Allegra-D, Alphagan-P, Aricept, Arimidex, Avalide, Avandia,Avapro, Casodex, Celexa, Clarinex, Coumadin, Cozaar, Depakote, Detrol LA, Diovan, Exelon, Flonase, Flovent, Fosamax, Glucophage XR, Hyzaar, Lamictal, Lipitor, Mirapex, Mobic, Nasonex, Neurontin, Paxil, Pravachol, Premarin, Prempro, Prevacid, Prograf, Proscar, Risperdal, Serevent, Singulair, Synthroid, Topamax, Vioxx, Xalatan, Zocor and Zyrtec -- should be particularly alert to the potential for manufacturer-created shortages.

Results for America, a project of the nonprofit Civil Society Institute, is not involved in any way in the health care industry or the recent lobbying on Medicare reform.

Pawlenty Fights Back on Pfizer Supply Limitations

February 26, 2004 - In a reaction to Pfizer Inc.'s move to cut off or limit supplies of it's medications to Canadian pharmacies selling to Americans, Minnesota Gov. Tim Pawlenty intends to ask the state's pension fund to draft a shareholder resolution opposing such moves.

The governor's idea is a novel idea in the battle that consumer groups and government officials have been waging to prevent pharmaceutical companies from reducing or cutting off supplies to Canada. Late last year, Minnesota Attorney General Mike Hatch launched an investigation into whether GlaxoSmithKline and other drug companies are committing a conspiracy as they limit drug sales to Canadian pharmacies.

Senate Discusses Making Internet Drug Purchases Illegal

February 13, 2004 - A bill that passed in the Health and Finance Committee that would make it illegal to buy prescription drugs over the internet is now being discussed in the Senate. The bill calls for criminal penalties for those who buy their prescription medications from any source other than a U.S. registered or licensed pharmacist.

This bill is exactly what hundreds of thousands of seniors and lower income citizens without drug coverage have feared might become law. These people have been taking advantage of the often enormous savings that can be realized by purchasing their medications from foreign sources, especially Canada. Many of these people simply cannot afford the higher prices charged at local pharmacies and, if this bill becomes law, will be forced to make some tough decisions on which expenses to reduce or cut out completely.

Personal medication purchases from foreign countries have traditionally represented less than 1% of total pharmaceutical sales within the country, a percentage that the American pharmaceutical industry seemed to be prepared to tolerate. But, with large cities and entire states now investigating the possibility of purchasing their medications from Canada, tensions are increasing on both sides of the border because of the potential increase in volume.

Seniors and low income citizens can only hope that, in their efforts to stem the massive importation of medications from Canada, lawmakers will not cut off the long-standing practice of allowing imported medication purchases for personal consumption. With 2004 being an election year, seniors can demand to know where candidates stand on personal consumption prescription imports from Canada and make their case for continuing to allow this life saving avenue to remain open.

FDA's Anti-Import Campaign Moves to California

February 12, 2004 - Federal authorities, who just finished a similar campaign in Illinois, will begin a consumer information campaign in California next week to discourage the state and local governments from trying to buy prescription drugs from Canada.

California state and local governments have been looking into the possibility of accessing cheaper medications from Canada but the FDA is telling them that it is illegal for states and cities to bring in drugs from foreign countries, even Canada.

Next week, the FDA along with local pharmacy organizations will be distributing fliers to be handed out at local pharmacies warning people of the dangers of buying medications from foreign sources. The fliers tell consumers that foreign drugs might not be manufactured according to FDA safety standards, that drug ingredients approved in foreign countries might not yet be evaluated by the FDA, the drugs could be counterfeit and patients taking foreign drugs might not be properly supervised by a doctor.

But proponents of plans to import drugs from Canada say that the FDA's safety argument doesn't hold water. They say that the drugs Canadians use are the same drugs sold here and are often produced by the same manufacturers.

Already, there are hundreds of thousands of Americans who purchase their medications from Canada either over the internet or by travelling to the country. But the practice of massive drug imports by states and large cities could develop into a supply problem (see article below). Canada's population is 1/10th the size of the U.S. and drug manufacturers have said they'll supply the country only enough medication to meet the needs of their country.

Canadian Pharmacy Group Warns Against Massive U.S. Importation

February 6, 2004 - Proposals supporting drug reimportation from Canada, advanced by several of the candidates for the U.S. Democratic Presidential nomination, are ill-considered and dangerous, according to the Coalition for Manitoba Pharmacy. "Saying you support massive reimportation of prescription medicines is irresponsible and lazy policy," said Lothar Dueck, president of the Coalition. "These statements by the candidates pander to people eager for relief, by making false promises."

The coalition says that some of the wide-scale re-importation proposals being put forward would put the Canadian healthcare system at risk. The Canadian system is not set up to supply medicines to the entire U.S. population which has ten times the population of Canada and drug manufacturers only ship to Canada sufficient supply to meet the needs of Canada's population.

Prescription purchases from foreign sources, including Canada, have traditionally represented less than 1% of total drugs sales in the U.S however if massive scale re-importation became the norm there is no telling how high that percentage could become. The present practice allows individuals to puchase their own pharmaceuticals either by visiting the foreign country or by making their purchases on the internet. While this practice has proven to be sustainable such would likely not be the case if institutional massive-scale ordering were to become the norm.

Michele Fontaine, vice president of the Coalition. said, "These simplistic proposals make no sense. If politicians sincerely want to help patients get access to medicines, why don't they sit down with the experts and do the hard work of figuring out a policy that has a chance of working safely?

Health-Care Discount Plan Now Available

January 9, 2004 - Finally, there is a health-care discount plan that is available to those who, for one reason or another, are not enrolled in any health insurance plan or cannot afford to pay the high premiums of an insurance plan. There is now a "plan B" available to these people that is designed to offer substantial savings from a whole variety of health service providers.

The organization offering this service, called Plan B for Health, has made arrangements with over 600,000 health care providers throughout the U.S. that offers their members often huge savings from what they would otherwise be faced with paying. Savings can be as much as 30% with doctors and hospitals and 50% on dental and vision health care costs. They even have arrangements with alternative health care providers like chiropractors, acupuncture practitioners, massage therapists, homeopaths and so on where the savings can amount to up to 30%.

PlanB for Health is an especially good deal for seniors with no insurance coverage. Over 200 models of hearing aids are available to members and include many styles. Their hearing care plan makes hearing services affordable with discounts up to 50% on services and products at over 1,600 locations throughout the U.S from one of the largest providers of hearing healthcare services in the country.

In addition the organization has discount arrangements with home care, assisted living, nursing homes, skilled care, intermediate care, and custodial. They have designed a plan to assist seniors to find the resources, answers and support necessary to meet and plan for the challenges of aging. If someone's current health provider is not already a participant in the Plan B for Health system they will contact the provider to encourage them to join.

Plan B for Health has a discount plan involving American pharmacies but they don't presently have any arrangements with Canadian pharmacies so people will still have to continue purchasing their Canadian prescriptions through their usual source. Canadian pharmacies, however, are not allowed to sell prescriptions to Americans that fall under the "narcotic" category so the Plan B for Health discount pharmacy plan can still come in useful for such purchases.

In our opinion, it is still better to have full health insurance coverage but, for many, coverage is simply not a viable option either because of the large premiums or for those who are ineligible for regular health insurance coverage. Under the Plan B for Health system, at least everyone is eligible to join and while the system won't pay for a patient's health care costs it will certainly offer members substantially savings on what they would otherwise have to pay.

Editorial - December 31, 2003 - It has been a very volatile year in the arena of drug importations from Canada. During the year, hundreds of "storefront" operations offering to facilitate Canadian prescription orders opened up and many have already been closed down by state pharmacy boards. Some states and cities have either been investigating or have already begun ordering their medications from Canadian sources but the Federal Drug Administration continues to advise them that these actions are illegal.

It has become fairly evident that the FDA is content to continue allowing personal prescription purchases made either by actually visiting Canada or by making personal orders over the internet. It has become equally clear that they don't want to see this practice become institutionalized either by way of storefront operations operating within the country or through massive ordering schemes organized by city or state governments.

Prescription purchases from foreign sources, including Canada, traditionally represent less than 1% of total drugs sales in the U.S., an amount that the pharmaceutical manufacturers may be prepared to accept. They are obviously not prepared to accept institutionalized prescription drug importation and many have begun limiting sales of their products to Canadian pharmacies participating in such processes.

2003 has seen an unofficial negotiation process with one side demanding unfettered access to less expensive medications from foreign sources and the other side demanding that all drug importations cease completely. Maybe 2004 is the year that a satisfactory compromise will be reached.

Details of New Medicare Bill

November 25, 2003 - The Medicare Bill that has just passed the Senate and is expected to become law after receiving the signature of President Bush will enable seniors to purchase insurance coverage for prescription drugs. However, many seniors aren't sure whether the bill will save them money or cost them more.

Following are the bare details of the bill and each family will have to "do the math" to figure if the new plan will offer any savings in their particular case.

The Kaiser Family Foundation provides a Medicare Drug Benefit Calculator to help you determine your own costs under the new bill.

Drug Importation Bill is Good News for Home Computer Sellers

November 21, 2003 - The Medicare reform bill headed for final House and Senate consideration before Thanksgiving includes a provision that would allow imports from Canada only if the Health and Human Services Secretary certifies they pose "no additional risk" to public health. Similar bills have twice failed to become law over the years as the HHS has always failed to make such a certification.

The purpose of the bill was to allow large scale importation of drugs by American drug wholesalers and pharmacy chains that would have resulted in citizens being able to purchase lower priced medications at their local drug store. With certification required from HHS this isn't going to happen.

Many seniors have been gaining access to lower priced Canadian medications from "storefront" operations throughout the country that facilitate the ordering process using the stores' computers and fax machines. However, the FDA recently won a ruling from US District Judge Claire Eagan that forced one of the major storefront operations to close its doors. Oklahoma-based Rx Depot and Nevada-based Rx of Canada, the targets of the lawsuit, together had 88 stores operating in 27 American states.

With the new bill having virtually no chance of becoming law combined with the closing of storefront operations around the country citizens will have no choice but to go back to the old methods of receiving their Canadian prescription drugs. For many years, the FDA has been turning a blind eye to individuals importing their own 90-day supply of medications either by making trips to Canada or by ordering them over the internet.

Perhaps foreseeing the FDA trying to cut of individual purchasing of personal medications from out of country the House of Representatives voted 237-176 to bar the FDA from spending any money on enforcement actions against drug imports during the current fiscal year.

Many seniors, however, consider themselves to be "computer illiterate" and therefore have resisted getting one for their home. For many, the cost of purchasing a computer and signing up for internet access would be more than offset by the money they would save from ordering their medications over the internet. This could be a huge opportunity for home computer retailers who could offer seniors the service of coming to their homes, setting up the internet service and showing them how to use search engines to access Canadian internet pharmacies.

Canadian Pharmacy Association Calls for Ban on Drug Exports

November 14, 2003 - A growing number of Canadian pharmacies are exporting prescription drugs to American citizens, creating regulatory challenges for those mandated to protect public safety says National Association of Pharmacy Regulatory Authorities' (NAPRA), Canada's voluntary umbrella association of provincial and territorial pharmacy licensing bodies.

The federal and provincial regulatory systems in Canada were not originally designed to regulate the export of prescription drugs. Provincial self-regulation of the profession of pharmacy and the distribution of drugs is intended to protect Canadians. Similarly, the federal drug approval process is designed so that Canadians will have safe and effective access to drugs.

Some government agencies have encouraged the export of prescription drugs because this trade fulfills the public policy objective of regional economic development. NAPRA believes that this objective may conflict with the public policy objective of Canadians' access to health care, specifically access to drugs and pharmacy services. Because of the conflict resulting from these competing objectives, NAPRA say that those government agencies responsible for their implementation must also be responsible for the consequences.

NAPRA says the export of prescription drugs is not always consistent with their vision of contemporary and indeed, future pharmacy practice. They say that this vision is founded on how pharmacists must respond to the needs of Canadians in the context of the Canadian healthcare system.

NAPRA says that, for these reasons, a Canadian solution is needed and they are requesting that the federal government ban the exporting of drugs from Canadian pharmacies to citizens of other countries until such time as governments can implement systems that will ensure the effective regulation of these practices to protect public safety.

Meanwhile, Health Canada spokeperson Krista Apse stated that to date, there have been no drug shortages in Canada because of this (Internet) practice.

Rx Depot and Rx of Canada Ordered to Close Operations

November 7, 2003 - An American company facilitating the purchase of lower priced Canadian prescriptions has been ordered by a US judge to stop supplying this service until a trial can be held on the matter.

Both Oklahoma-based Rx Depot and Nevada-based Rx of Canada have been charged for the practice of forwarding American prescriptions to Canadian pharmacies to have the orders filled. Both operations combined have 88 stores operating in 27 American states.

Yesterday, US District Judge Claire Eagan rules that the companies have to close down their operations until a trial can be held to determine whether or not they have broken any laws with regard to the importation of foreign and even the re-importation of US made drugs into the country.

The trial will determine which of the two parties is correct in their respective interpretations of the law. The Food and Drug Administration contends that these companies are breaking the law by importing drugs into the country. Meanwhile the companies contend that they are not importing drugs at all, but simply facilitating orders placed with them by individuals and that the medications are delivered directly to their customers' addresses.

Americans have the option of ordering their medications from Canada over the internet themselves however most, if not all, of the customers of these facilitating companies either do not have access to the internet or don't know how to go about placing an order on the internet.

Gutknecht Says Drug Companies Policies Harmful

November 1, 2003 - U.S. Rep. Gil Gutknecht, R-Rochester, is asking the Justice Department to investigate drug manufacturers for manipulating the drug supply by restricting shipments to Canada to block cross-border sales.

"Six major pharmaceutical manufacturers have moved to restrict supply of prescription drugs to Canadian pharmacies and wholesalers," Gutknecht wrote to Attorney General John Ashcroft, in a letter signed by 21 other House members. "It is obvious that these actions are an attempt to prevent American consumers from accessing affordable prescription drugs. This action is putting lives at risk in the United States and Canada."

A month ago, Minnesota Attorney General Mike Hatch filed a suit against GlaxoSmithKline, claiming the drug company was leading an industry-wide conspiracy to keep Minnesotans from buying Canadian drugs.

On Thursday, a bipartisan group of U.S. congressmen from both the Senate and the House of Representatives said they were preparing a bill that would fully legalize the import of Canadian drugs, and would expand the FDA's powers so it would regulate the quality of both domestic and imported drugs. If passed, such a bill could turn Canada, with its government-regulated drug prices, into the major supplier of drugs to the United States.

The weapon the pharmaceutical companies have been wielding recently has been to limit the supply of drugs they will sell to Canadians in order to stem the reimportation of these drugs back into the U.S. But this tactic can only go so far, because Canada has a powerful potential defence under World Trade Organization rules. If drug companies make important drugs too expensive or difficult to obtain, WTO rules say, the government can impose "compulsory licencing" under which domestic companies can be allowed to make generic copies of the previously patent protected drugs.

Lilly to Limit Product Sales to Canada

October 19, 2003 - Eli Lilly and Co. has joined the list of pharmaceutical giants who have decided to prevent its drugs from being sold to American consumers from Canada at prices far below those available in the United States. Lilly has written 24 Canadian drug wholesalers telling them it will limit sales of its drugs based on company estimates of product amounts that should be sufficient to supply the Canadian market only.

Previously, pharmaceutical giants Pfizer of New York and GlaxoSmithKline of Great Britain took similar steps against Canadian pharmacies that sell drugs to U.S. customers.

Battle lines are continually being re-drawn between the two sides, one comprised of millions of senior citizens living on fixed incomes and supported by a growing number of U.S. Governors, members of Congress and presidential candidates who wish to formally legalize the purchasing of Canadian prescription drugs. On the other side are the pharmaceutical giants and their supporters who want this "Canadian alternative" avenue closed off, forcing seniors to purchase their medications from American regulated avenues only.

The FDA meanwhile seems to be maintaining their policy of allowing personal-use prescription purchases from Canada either over the internet or by actually making trips across the border. They have, however, been lending their moral support to the pharmaceutical industry in various testimonies by stating that they cannot insure the safety of medications purchased outside of the U.S.

State of Minnesota Launches Suit Against Glaxo

October 18, 2003 - With Minnesotans facing skyrocketing health care costs and no substantial legislative reforms having been implemented, Attorney General Mike Hatch has issued a report entitled, “Follow the Money. The Pharmaceutical Industry: The Other Drug Cartel,” which describes the pharmaceutical industry’s undue influence over the legislative process at both the State and federal levels.

Hatch also announced the filing of a legal action against GlaxoSmithKline, the world’s second largest drug manufacturer, to compel the company to produce documents in connection with his office’s ongoing investigation into the company’s boycott of Canadian prescription drug imports.

GlaxoSmithKline previously notified Canadian wholesalers and pharmacies that it will stop supplying them with its pharmaceuticals if they sell drugs to United States citizens. In May, 2003 the Minnesota Attorney General’s Office served a Civil Investigative Demand (“CID”) on Glaxo in connection with the office’s investigation into whether the company violated the State’s antitrust laws and illegally restrained trade by forcing Canadian companies to comply with its boycott demands and conspired with other drug companies to block Canadian drugs sales. Glaxo has refused to produce to the Attorney General’s Office documents that are located in Canada, where the boycott occurred, or England, where it is headquartered.

“Glaxo’s arrogance has been demonstrated two-fold: first by boycotting Minnesotans who go to Canada to save money on their drugs, and now by essentially ‘boycotting’ this office by refusing to produce its records in Canada and England,” Hatch said.

In the action against Glaxo, the State requests the Hennepin County District Court to order Glaxo to produce documents regarding its refusal to supply Canadian wholesalers and pharmacies that sell drugs to the United States via the Internet. The Attorney General’s Office, which has been investigating the drug manufacturer for months, was forced to make the request in court after Glaxo refused to supply the documents responsive to the CID.

Glaxo, which has its U.S. headquarters in Philadelphia, Pennsylvania, manufactures a wide variety of well-known prescription drugs, including blockbusters Paxil (for depression), Zantac (for ulcers), Augmentin (an antibiotic), Zyban (for smoking cessation), Advair (for asthma), and Avandia (for diabetes). In 2002, Glaxo reported worldwide sales of $31.8 billion and pretax profits equal to 30.5 percent of sales.

Governor Blagojevich Starts Internet Petition to Allow Canadian Drug Imports

October 14, 2003 - Gov. Rod Blagojevich wants to bring down prescription drug prices to save money for taxpayers and consumers in Illinois. He is asking the U.S. Food and Drug Administration to allow Illinois to explore a plan to import approved medications from Canada for half the price.

You can help Gov. Blagojevich put pressure on the FDA to recognize the drug price crisis in the U.S. and to reverse its policy banning U.S. consumers and local governments from buying their medications for less in Canada.

The Governor is asking consumers to fill out an online petition in support of drug importation at www.affordabledrugs.il.gov

October 31 for Final Submissions in Justice Dept/Rx Depot Lawsuit

October 10, 2003 - U.S. District Judge Claire Eagan has given both sides in the Justice Dept/Rx Depot lawsuit until October 31st to make their final submissions afterwhich she is expected to rule in the case.

The Justice Department is attempting to get the court to rule on a request for a nation wide injunction against Rx Depot, headquartered in Tulsa, Oklahoma, that would prevent them from carrying on the business of facilitating Americans purchasing medications from Canada.

The Justice Department claims that Rx Depot is breaking the law and putting the public at risk by importing drugs from Canada outside FDA scrutiny. Rx Depot contends that it is doing nothing other than facilitating access to Canadian medications similar to what people do all the time either over the internet from their own homes or actually travelling to the country.

FDA officials continue to contend that the safety of Canadian medications cannot be ensured as they don't fall under the scrutiny of American officials. However, Rx Depot says that there are no problems with medications coming from Canada as all such medications are regulated by Health Canada.

Mayor Michael Albano of Springfield, Mass. has stated his city's intentions to purchase medications for city employees through a Canadian source based on FDA comments to Congress that it would not stop individuals who go to Canada to buy drugs or those who buy them over the Internet.

If operations like Rx Depot are forced to close then seniors and other low income citizens with no internet access will again be forced to pay the much higher costs of medications from their local pharmacies. In many cases these people could easily afford to buy a computer and pay for internet access with the money they would save by purchasing their medications from Canada over the internet. Many seniors, however, erroneously believe that operating a home computer is a complicated procedure and prefer to be able to walk into shops like Rx Depot and place their order.

North Carolina Storefront Closes Shop

August 25, 2003 - A North Carolina storefront operation facilitating the ordering of prescription medications from Canada has closed its doors. Rx Price is Right of Winston-Salem had just opened May 1 when only a month later they received a cease-and-desist order from the N.C. Pharmacy Board.

Five North Carolina had received cease and desist notices from the Pharmacy Board however only two have closed their doors to date. Customers of Rx Price is Right who wish to continue having access to Canadian priced medications will have to either find another storefront operation or else find a way to get internet access so they can order their medications directly from a Canadian pharmacy.

Generics Only US Pharmacy Opens Up

August 13, 2003 - In an apparent response to the increasing practice of Americans seeking to find affordable means of acquiring their much needed prescription medications, an internet pharmacy has begun a service that deals in FDA approved generic forms of medications only.

The pharmacy, ShipDrugs, says that generic prescription medications are always less expensive than their brand name counterparts. They also point out that all medications sold through their facilities have the FDA stamp of approval. ShipDrugs is an internet pharmacy that ships all products to customers by courier thus ensuring speedy delivery.

A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use and is chemically identical to its branded counterpart.

Drug companies must submit an abbreviated new drug application (ANDA) to the FDA for approval to market a generic product.

New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug's development by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity expire, manufacturers can apply to the FDA to sell generic versions.

Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug.

Montana Board of Pharmacy Files Suit Against Storefront Operation

August 8, 2003 - The Montana Board of Pharmacy has filed suit against Rx Depot, a storefront operation facilitating the purchase of low cost prescription medicines from a Canadian pharmacy.

The suit, filed last week in the District Court in Helena, claims that the operation is violating a number of federal and state laws and should be shut down immediately. RX Depot claims that it is doing nothing different than people can do over the internet from their own homes but is just assisting people who either have no internet access or who don't know how to use their computers to order over the internet themselves.

Some seniors are concerned that if lawsuits are successful in shutting down storefront operations such as Rx Depot that such rulings could spill over to encompass the internet purchases that people regularly make from their homes. This is not likely to occur as the FDA some time ago decided not to enforce drug imporation provisions as long as the prescriptions were for personal use and for no more than a 90 day supply per order.

Look for Old "Status-Quo" on Canadian Drug Imports

August 4, 2003 - It was a slow and steady progression that started with American tourists who happened to purchase some prescription medications out-of-country and discovered that it was not a problem to bring those medications back into the country. Although it was technically against the law to bring back those medications, the FDA and customs officials realized that the law was not meant to prevent individuals from purchasing their own personal medications in another country and bringing them back on their return home.

Thus the policy of allowing people to purchase up to a 90 day supply of their personal medications out-of-country for home consumption began. But then word spread about the savings that were possible and seniors groups started organizing bus trips to Canada for the express purpose of purchasing lower priced prescription drugs. That was fine for people near the international border but too costly and time consuming for those not so near to the border.

The next progression was the internet which allowed people anywhere in the country to do the same thing as those living close to the border had been doing, buy a 90 day supply of their own personal medications from a Canadian pharmacist at greatly reduced prices. At this point there were no alarm bells ringing in the offices of the pharmaceutical giants' offices. Between personal purchases made on out-of-country visits and internet purchases combined, such purchases represented less than half of one percent of the total American prescription purchases.

But then something a lot bigger started happening and that something was "storefronts" facilitating internet puchases for Americans who didn't have access to the internet from their own homes. Throughout the country, entrepreneurs recognized that there were many millions of people who don't have internet access and so they began opening up "storefront" operations that allowed these people to walk into their outlets where the operators would perform internet purchases on their behalf. That's when alarm bells started to ring.

It was at this point that individual pharmacys were beginning to get upset as storefronts just down the street began offering identical medications at a fraction of the prices they were charging. Complaints were made to various state and federal authorities basically saying that these storefronts were operating unlicensed pharmacies and should be shut down. The problem here was that these storefronts were not actually operating a pharmacy but rather they were only facilitating the same types of purchases that people with internet access were making from their own homes.

The major pharmaceutical companies were also upset with these storefront operations opening up but their concerns at that point were significantly increased when various congresspersons and senators began talking about the full legalization of importing prescription medications into the country, not only from Canada, but from up to 25 other countries as well. If such legislation were to come into effect, not only would individuals be able to legally bring in personal medications from out-of-country but so would pharmaceutical wholesalers. Such a law would result in the loss of billions of dollars each year in revenues and profits.

Prescription medication importation legislation has been passed in both the Senate and the House however there are substantial differences in the wording of each bill and these differences are now in the process of being reconciled. One of the most significant differences is a provision in the House bill which orders the Health and Human Services Department to set up a system to allow importation of FDA-approved drugs from FDA-approved facilities. In past bills the legislation was dependent on the HHS voluntarily certifying the safety of imported medications which they have each time refused to do.

Many pundits predict that such a provision requiring HSS to set up a system will not make it into the final bill in which case the bill will not become law because the HSS is unlikely to voluntarily certify the safety of imported medications. So after all the lengthy discussions and debates on this matter we are almost certain to see this type of legislation fall flat as it has done in the past in which case it will still be illegal to import medications into the country. The bill is now pending in the Senate's Committee on Health, Education, Labor and Pensions.

So what happens then to the storefront operations, internet purchases and people travelling across the border to buy their personal medications? Can the authorities cut off all avenues for seniors and other lower income Americans to acquire affordable medications from out-of-country? Probably not. While they could they probably won't, at least not completely. The seniors lobby is just too strong to allow authorities cut off every single avenue.

The storefront operations are perhaps their largest concern because they are an "in your face" problem for individual pharmacies that may be operating right next door. From the pharmaceutical giants' perspective, these storefronts make out-of-country purchases "too" accessible. As a result, we can probably expect to see either federal or perhaps individual state legislation that will make it illegal to facilitate the importation of controlled drugs through "unlicensed" facilities such as storefront operations.

So, in the end, we can probably look forward to a return to the old status quo where people can either make trips across the border or make individual purchases of their medications over the internet. This level of out-of-country medication purchasing offers seniors and low income Americans at least some access to reasonably priced medications while at the same time almost ensuring that the vast majority of prescription medication will continue to be bought at American pharmacies.

City of Springfield Decides to Buy Canadian Drugs

July 30, 2003 - On the heels of the House of Representatives passing a bill last week that would allow Americans to import out-of-country medications, the City of Springfield, Massachusetts has started buying Canadian drugs for their retirees and employees.

Individuals have been buying Canadian medications for years now, either by taking organized bus trips across the border or simply by ordering over the internet but, to our knowledge, this is the first time that a city has decided to make this money saving decision.

Canadian Pharmacy Group Applauds U.S. House Vote
Approving Imported Prescription Drugs

CALGARY, Alberta, July 28 /PRNewswire/ -- The Canadian International Pharmacy Association, Canada's leading group of pharmacies which provide international prescription services to U.S. patients, applauds the outcome of the vote by the members of the U.S. House of Representatives on the Pharmaceutical Market Access Act of 2003. Members from both sides of the House voted to pass the legislation (243 to 186) last Friday morning.

"We heartily applaud the U.S. House's wise vote to support seniors and America's working poor, who need access to low-cost and safe Canadian drugs," said Andy Troszok, vice president standards of the Canadian International Pharmacy Association. "Despite the drug industry's millions of dollars in lobbying against the bill and conjuring up the wildest accusations against Canada's pharmaceutical distribution system, House members were not persuaded to kill the legislation. The members of the House realized that American consumers desperately need access to more affordable medications and that Canada can deliver a safe alternative."

Troszok says that more than 1 million Americans currently access Canada's safe prescription drugs. "Our members are proud to say that we serve hundreds of thousands of customers each year, and there has never been a major negative incident involving Canadian drugs," added Troszok.

"The drafters of the legislation were mindful of the various straw-man arguments about the safety of imported medications from Canada that the multinational drug companies have used to fight the importation issue. Those issues have been addressed, " said John Myers, CIPA's General Counsel, "as long as the prescription drugs are manufactured in an F.D.A.-approved facility in Canada, the European Union and several other nations."

The legislation will also put in place a series of counterfeit-resistant technologies to the packaging and labeling of imported drugs.

"Although Canada's prescription drug distribution system is as secure as systems in the United States, if these measures provide our patients with additional confidence in the medications they receive from our member pharmacies, then CIPA will support these new requirements", said Troszok. "CIPA hopes to play a role in developing the technologies referred to in the legislation."

To help strengthen the pharmacies' safety message, in June, a U.S. Congressional Research Service Study found that Canadian and U.S. drugs are made and distributed using nearly identical standards.

While the pharmacies sell their drugs at prices up to 30 to 85 percent less than U.S. prices, the major drug manufacturers are not losing that much. After all, Canada's drugs are made by the major pharmaceutical makers including Pfizer, Wyeth and Merck, all of which have subsidiaries in Canada.

To keep Americans paying the highest drug prices, in recent weeks, the pharmaceutical industry lavishly spent millions of dollars to take out a major national media campaign portraying imported drugs as unsafe, encouraged friendly politicians and religious groups to negatively position the move as opening up the country to unwanted medications, and, in an unusual step, may have played a role in having the FDA lobby legislators.

CIPA is hopeful that the U.S. Senate and President Bush will have the foresight to support the House bill. But, it recognizes this is a tough battle that pits it against an all-powerful drug lobby with an unlimited bankroll that affords it one lobbyist per member of Congress, and using lobbying efforts that Rep. Bart Stupak (D-Mich.) referred to as "dishonest and hypocritical."

The bill (HR2427) was led by Reps. Gil Gutknecht (R-Minn.), Jo Ann Emerson (R-Mo.) and Rahm Emanuel (D-Ill.).

The U.S. and New Zealand are the only industrialized nations that do not manage their drug prices.

With member pharmacies across Canada, CIPA is Canada's leading association that represents pharmacies providing services to U.S. patients. CIPA's members serve more than one million uninsured and low-income patients in all 50 states. Before patronizing these pharmacies, many customers had been unable to afford their medications.

Medication Importation Bill Passes House

July 25, 2003 - In a hefty majority vote of 243-186 this morning the House approved a bill which would allow the importation of prescription medications, not only from Canada, but from the European Union and seven other nations.

The major difference between this bill from others in the past is that the new bill, sponsored by Reps. Gil Gutknecht, R-Minn., Jo Ann Emerson, R-Mo., and Rahm Emanuel, D-Ill., orders the Health and Human Services Department to set up a system to allow importation of FDA-approved drugs from FDA-approved facilities. In past bills the legislation was dependent on the HHS voluntarily certifying the safety of imported medications which they have each time refused to do.

But seniors with no internet access shouldn't start breaking out the champagne just yet. Over 600 pharmaceutical industry lobbyists have been working very hard in Washington over the last while in an effort to ensure that importation legislation not become law. Indications are that importation legislation may have problems in the Senate and does not have the support of the Bush administration.

In all likelihood, seniors without internet access will continue to board buses organized to cross over into Canada to pick up their much needed prescriptions at a reasonable price. Meanwhile seniors with internet access can watch the fight from the sidelines and continue as they have been in the past, ordering their medications from Canadian based internet pharmacies.

53 Senators Sign Letter Opposing Drug Reimportation Bill

WASHINGTON, July 25 /CNW/ -- On the heels of an early-morning vote in the House of Representatives to allow the importation into the United States of drugs from 26 countries, 53 Senators from both Parties have signed a letter opposing the provision as House and Senate conferees meet to discuss Medicare prescription drug legislation in the weeks ahead.

It is generally viewed as unlikely that majority Republicans in either House would jeopardize one of President Bush's major domestic priorities -- a prescription drug benefit for senior citizens -- over the relatively obscure and highly controversial drug importation provision.

"The (Health and Human Services) Secretaries of both the Clinton and Bush Administrations have not been able to demonstrate that drug importation is safe or cost effective," the 53 Senators said.

The Senators also noted that "the Senate has three times unanimously supported" legislation requiring that the Secretary of Health and Human Services determine that drug importation could be accomplished safely before importation be permitted, but that the House-passed measure would "eliminate this safety requirement."

"We do not believe it would be prudent to remove these vital safeguards," say the 53 Senators, who note that "drug importation is opposed by the FDA, two Secretaries of Health and Human Services from both Republican and Democratic Administrations, the U.S. Customs Service, and the Drug Enforcement Administration."

A copy of the letter follows:

United States Senate Washington, DC 20510 July 24, 2003

The Honorable Bill Thomas Chairman, Committee on Ways & Means U.S. House of Representatives 1102 Longworth Office Building Washington, D.C. 20515

The Honorable Billy Tauzin Chairman, Committee on Energy & Commerce U.S. House of Representatives 2125 Rayburn House Office Building Washington, D.C. 20515

The Honorable Charles E. Grassley Chairman, Committee on Finance U.S. Senate 219 Dirksen Office Building Washington, D.C. 20510

Dear Chairmen Thomas, Tauzin and Grassley:

As conference begins on reconciling the differences between the House and Senate versions of Medicare prescription drug legislation, we urge you to maintain the strong safety requirements pertaining to importation of drugs that are in both bills. As you know, both the House and the Senate passed legislation to provide Medicare beneficiaries with a prescription drug benefit and improve access to more affordable generic drugs for all Americans. We feel it is unnecessary to change current law and deny the authority of the Secretary of Health and Human Services (HHS) to decide whether drug importation is safe and cost-effective.

Congress has debated the issue of drug importation many times, and in fact, passed the Medicine Equity and Drug Safety (MEDS) Act of 2000, The MEDS Act allows the importation of pharmaceuticals into the U.S. as long as the Secretary of HHS is able to demonstrate to Congress that implementation would: 1) pose no additional risk to the public's health and safety; and 2) would result in a significant reduction in the cost of covered products to American consumers. Since enactment of the MEDS Act, the HHS Secretaries of both the Clinton and Bush Administrations have not been able to demonstrate that drug importation is safe or cost-effective. Therefore, the law has not been implemented to date.

Despite the fact that the Senate has three times unanimously supported passage of this safety/cost-effectiveness contingency trigger on importation legislation, there are those in both the House and Senate who are seeking to eliminate this safety requirement. We do not believe it would be prudent to remove these vital safeguards, especially when Congress is in the process of enacting a Medicare prescription drug benefit that includes improved access to more affordable generic drugs. Moreover, drug importation is opposed by the FDA, two Secretaries of HHS from both Republican and Democratic Administrations, the U.S. Customs Service, and the Drug Enforcement Administration (DEA), even if it is limited only to Canada.

We urge you to oppose efforts to weaken current law that requires the Secretary of Health and Human Services to demonstrate that implementation of drug importation will pose no additional risk to the public's health and safety and result in a significant reduction in the cost of covered products to the American consumer.

Sincerely,

Senator Alexander Senator Corzine Senator Inhofe Senator Santorum
Senator Allen Senator DeWine Senator Kennedy Senator Shelby
Senator Bayh Senator Dodd Senator Kyl Senator Smith
Senator Bennett Senator Dole Senator Landrieu Senator Specter
Senator Bond Senator Domenici Senator Lautenberg Senator Stevens
Senator Breaux Senator Ensign Senator Lott Senator Sununu
Senator Bunning Senator Enzi Senator Lugar Senator Talent
Senator Campbell Senator Fitzgerald Senator McConnell Senator Thomas
Senator Carper Senator Graham (FL) Senator Mikulski Senator Voinovich
Senator Chafee Senator Gregg Senator Murkowski Senator Warner
Senator Chambliss Senator Hagel Senator Murray Senator Wyden
Senator Cochran Senator Hatch Senator Nelson (NE)
Senator Coleman Senator Hollings Senator Nickles
Senator Comyn Senator Hutchison Senator Roberts

 

Pharmaceutical Giants May Not Get "Bang for their Buck"

July 22, 2003 - Even though the pharmaceutical industry doled out over $26 million to political candidates in 2002 there is a growing concern that their lobbying efforts won't be panning out when the House votes later this week on the drug "re-importation" bill. Even though Republican candidates were the largest recipients of drug company contributions it appears that some of their members are leaning towards passage of the bill.

Although similar bills have passed the House in previous sittings they have never been able to be enacted into law as the bills have always required the secretary of Health and Human Services to certify that reimportation can be done safely, something the secretary has always refused to do.

But this time Republican Rep. Jo Ann Emerson, the Missouri congresswoman, has already garnered support for her contention that the bill should include a provision that safety certification by HHS need not be a requirement. Americans have, in fact, been purchasing medications from Canada for years now and, while technically illegal, the Federal Drug Administration has always turned a blind eye to these imports as long as they were purchased by the end consumer themselves and they imported no more than a 90 day supply.

Even though millions of packages pass through from Canada to the US each year Mr. William K. Hubbard, FDA Associate Commissioner of Policy and Planning, testifying before a House Subcommittee in April this year, could not cite one example of a medicine shipped from a Canadian pharmacy which did harm to an American consumer. The growing opinion is that the potential of unsafe or even dangerous drugs coming in from Canada is simply a bogus issue.

It may be that the last line of defense for the pharmaceutical giants will rest with President Bush whose signature is required before the bill becomes law.

The Scare Tactics on Canadian Drugs Continue

July 21, 2003 - It seems that, recently, not a day goes by where one cannot read some article warning seniors about the dangers of ordering prescription medications from outside the country, even from Canada.

These harbingers of doom have given up on actually stating that there is any harm in medications going through the official Canadian medication supply chain. What they are asking now is how seniors can actually know whether or not the internet pharmacy is actually getting their medications from a licensed Canadian pharmacist.

These warnings state that even though an internet pharmacy says they are from Canada they may actually be getting the medications from places like Bangkok or Sri Lanka. That's why internet pharmacies such as Canada Pharmacy, whose prescriptions are all filled by North Pharmacy in British Columbia, have a link to the province's College of Pharmacists where customers can check to see that they are, in fact, fully licensed Canadian pharmacists operating under Health Canada regulations.

So while it may be possible for someone to set up a internet site purporting to be a Canadian pharmacy, when in fact the drugs were actually coming from some other source, it doesn't take much investigation to determine which are and which are not legitimate Canadian based pharmacies. Canada Pharmacy is also a designated Certified Canadian International Pharmacy, a designation that is not possible to be obtained by illegitimate websites.

You'll Have to "Do the Math" on Drug Cost Savings

July 5, 2003 - Already, some seniors have started calculating savings in prescription medication costs under both the House and Senate's proposed drug coverage plans. For seniors who don't have internet access allowing them to purchase medications from Canadian pharmacies the savings can be quite substantial. With an annual medication cost of say, $4,000, a senior without internet access could save between 30-40% depending on which plan gets passed into law. Unfortunately, whichever bill that eventually passes will not take effect until 2006 so seniors without internet access will still be waiting for a few more years to realize any savings.

But some seniors, currently purchasing their medications on the internet from Canadian pharmacies, are saving 50% or more right now. For these people, not only would participation in the new system cost them more money but also any subsidies on prescription medications would increase the overall tax burden.

Emerson Negotiates Elimination of HSS Canadian Drug Safety Certification

June 27, 2003 - It appeared that the Medicare prescription drug bill was going to be defeated until Republican Rep. Jo Ann Emerson, the Missouri congresswoman, came out of a huddle with Speaker Dennis Hastert and other bill proponents to change her vote from no to yes. The final vote was 216-215 in favor of the bill passing.

What Emerson had been fighting for was a promise that the final bill would take away authority from the Food and Drug Administration that allows it to block importation of Canadian drugs. Emerson said the final bill will eliminate the requirement that the secretary of Health and Human Services certify that reimportation can be done safely.

Department of Health Approval is Key to Drug Import Legislation

June 26, 2003 - Both the Senate and House bills in consideration regarding Medicare include a provision that would allow individuals, pharmacists and wholesalers to import U.S.-made drugs from Canada, where they are sold for less because of the Canadian government's price controls. Both bills require the Department of Health and Human Services to certify that the imports would be safe and would save money, something HHS has declined to do.

It's not that anyone actually believes that Canadian medications are not as safe as those produced and sold in the US. But how is HHS supposed to be able to certify to the safety of imports over which they have little ongoing control? The HSS has no authority in other sovereign nations and would therefore have to rely on safety certifications of the exporting nation's Health Departments.

One method open to them might be to make random medication purchases from other countries from time to time and then have those products tested in US facilities. But if HSS is supposed to be able to offer a safety certification under its current mandate where it has full inspection control then it is difficult to see how either the Senate or House bills could become law. What is more likely to happen is that the current system will simply continue whereby seniors and others purchase a maximum three month supply of their medications from Canadian pharmacies and the FDA turns a blind eye to these "illegal" imports.

Senate Votes to Allow Canadian Medication Imports

June 20, 2003 - An amendment to the Medicare bill which would allow for the legal importation of prescription drugs from Canada passed in the Senate today with a vote of 62-28. Many Americans have been ordering medications from Canada in recent years and the FDA has been under pressure from the pharmaceutical industry to put a stop to this practice. But equal or greater pressure has been applied by seniors and other low income advocacy groups to their elected representatives to keep this avenue to affordable medications open.

The amendment, introduced by Sen. Byron Dorgan, D-N.D., was based on the argument that Canada provides safety controls that are just as reliable as the U.S. Just a few weeks ago a Congressional Research Service analysis requested by Representative Bernard Sanders (I-VT) confirmed that the Canadian regulatory system for prescription drugs is comparable in all substantive respects to that in the United States.

Opponents of the amendment stated security concerns indicating that allowing such imports would open up a new avenue for bioterrorism. However the memorandum produced by the Congressional Research Service has already stated that all Canadian prescription drug manufacturing facilities and distribution facilities must meet strict Good Manufacturing Practices and that Canada maintains strict chain of custody requirements.

All prescription drugs on the Canadian market must be approved for sale to Canadian consumers and must include contact information of every company that has handled the product along the chain of distribution. In addition, all prescription drugs approved for sale in Canada carry a distinctive numerical code used to track the product.

CRS Analysis Confirms Canadian Prescription Drugs Safe As U.S.

June 12, 2003 - Representative Bernard Sanders (I-VT) today announced that a Congressional Research Service analysis he requested has confirmed that the Canadian regulatory system for prescription drugs is comparable in all substantive respects to that in the United States. Sanders said this shows that the drug companies' scare tactics about the safety of medicine from Canada are red herrings designed to distract attention from the fact that the pharmaceutical giants charge Americans far higher prices than they charge Canadians.

Sanders said, "The new CRS analysis should put the stake through the heart of the drug companies' lies about the Canadian regulatory system. Now it's time to turn out attention to the real issue. American consumers are charged the highest prices in the world for prescription drugs, and we need to put a stop to it. The U.S. Food and Drug Administration should stop carrying water for the drug companies and work with those of us in Congress who want to give Americans access to safe and affordable medicines from highly regulated Canadian pharmacies. In the long run, this will force the drug giants to start selling their products in the U.S. at lower prices."

The CRS memorandum confirms that all Canadian prescription drug manufacturing facilities and distribution facilities must meet strict Good Manufacturing Practices and that Canada maintains strict chain of custody requirements. All prescription drugs on the Canadian market must be approved for sale to Canadian consumers and must include contact information of every company that has handled the product along the chain of distribution. In addition, all prescription drugs approved for sale in Canada carry a distinctive numerical code used to track the product.

Sanders continued, "Despite industry attempts to scare American seniors away from buying their medications in Canada because of alleged safety concerns, this new CRS analysis reaffirms that the only real difference between prescription drugs in the United States and Canada is the enormous difference in price. The two countries regulate prescription drugs in virtually identical ways from manufacturing and importation to labeling, distribution, and sales. Every prescription drug manufacturer, wholesaler, and distributor in Canada must be licensed by the federal government, and every pharmacy and pharmacist must be licensed by their provincial government."

Medicare Is Fine Model for Single-payer Health System
by Marjorie B. Colson

June 11, 2003 - I am an 80-year-old American enrolled in a 40-million-member single-payer health plan called Medicare. I have been enrolled in Medicare for 15 years, and while I am not 100 percent satisfied with the program, I wouldn't trade it for any private health insurance plan anywhere in the world. I have good company, and lots of it. Roughly 40 million people agree with me.

Here's why:

I know, when I go to the doctor or to the hospital, my bills will be paid. Twice over the past two years, I have been in the hospital as the result of a fall. Once I broke my hip and needed a stay in the hospital, hip surgery and follow-up rehabilitation; and once I fractured an ankle and sprained my feet and one knee, requiring, again, hospitalization and follow-up rehabilitation at a nursing home. For those services, plus many additional weeks of outpatient therapy, I paid nothing.

I feel fairly secure about my health insurance plan, as it is shared by about 40 million people, most of whom are prepared, at the drop of a hat, to take action to foil government officials proposing changes in our plan that might affect us adversely.

I am very familiar with the power of Medicare recipients, being the president of a large senior organization in central Wisconsin, and being responsible on occasion to organize a response to a government action that we feel threatens our health and our quality of life. Something called "Third Rail Politics" has been developed around both the Medicare and Social Security programs as a result of our activism on behalf of ourselves and others like us.

Because my health plan is public, a government plan, I have three elected officials who might be said to sit on the board of my health plan. My representatives are accountable to me and my fellow seniors, and respond to our complaints and problems.

If I were in a private health plan, the board would be made up of individuals appointed by shareholders. Such board members are never accountable to patients of their health insurance or health maintenance companies. Patients, in fact, don't know who board members are and have no right to try to speak to them about the quality of their care.

I suggest that fellow citizens enrolled in smaller splinter groups called private insurance plans might want to look at the ability of senior and disabled people to defend our programs and ourselves, and consider trying to get into our single-payer plan or a similar government health plan. I can guarantee, after 15 years in Medicare, that it will take a huge worry from your mind.

I have absolute freedom to choose my doctor or other health care provider. I have a government-issued card that guarantees me entrance to the clinic or hospital of my choice. And my membership in the huge Medicare club assures me help and support when I need it.

Like many senior and disabled people on Medicare, I do not currently have a prescription drug benefit. That situation, interestingly, is being remedied (at least partially and temporarily) by the small free market that happens to still exist in the nation. Storefronts and Internet sites selling drugs at Canadian prices are proliferating so rapidly that retail pharmacists are trying to organize to force seniors and disabled people to return to their own more pricey U.S. pharmacy counters. It won't happen, as more and more Medicare recipients find their own cut-rate pharmacies with Canadian prices. We are creating our own remedy, e-mailing each other as we find new and better drug prices in Canada - a country with a single-payer health care system that serves all of its citizens.

When people talk about how hard it is to repair the broken health care system in the United States, I respond by reminding them that a rational and realistic solution exists:

Single-payer anyone? Join the club.

Marjorie B. Colson lives in Madison, Wisconsin and is active with many local groups, including the Dane County SOS Senior Council.

Storefront Operators Face-off with Pharmacy Board in Florida

June 10, 2003 - Passions were running high as a number of storefront operators who offer to facilitate access to Canadian discount medication met for the first time yesterday with pharmacists and state regulators during a Florida Pharmacy Board meeting.

Apparently, storefront operators attending the meeting were looking for some way to to reach an amiable arrangement whereby the two parties could co-exist in some degree of relative harmony. But board members were not in any mood to come to an arrangement of any kind reiterating their position that these types of operations put consumers at risk of getting unsafe or counterfeit drugs.

Storefront operators contend that saftey isn't a real issue with medications imported from Canada. Medicines dispensed in Canada come under the control of Health Canada, the Canadian equivalent to the FDA. There has never been an incident where a prescribed medication dispensed from a licensed Canadian pharmacy has caused harm to an American. Just like American pharmacists, their Canadian counterparts are bound to dispense whatever formulations that are prescribed by the customer's physician.

The FDA does not appear to be making any moves towards removing access to Canadian medications through the placement of personal internet orders however they have been lending their moral support to states that are attempting to shut down these American storefront operations offering to facilitate such orders.

While the state of Florida has been investigating storefront facilitation operations they have given no indication either if or when any such operations will be prosecuted. With no official state action in sight, the board indicated that they plan to embark on a $750,000 media campaign to warn consumers about the dangers of ordering Canadian medications over the internet or from storefront operations.

Good News for Philadelphians with No Internet Access

June 6, 2003 - A new storefront operation has opened up in Philadelphia offering facilitation services to seniors and others who are most in need of medications whereby they can receive more reasonably priced medications from Canada. The storefront operation, called Ameri-Can Discount Drugs, opened up in April this year and has since been providing this service to people who don't have internet access in their own homes

Like other storefront operations that have been opening throughout the country in recent months, Ameri-Can simply places the internet order on behalf of these people. The financial transaction remains between the Canadian pharmacy and the customer and the medicines are then delivered directly to the customer's home.

So far, we are unaware of any response to this storefront operation by the state Pharmacy Board. Other state boards have gone as far as to issue orders for these types of operations to cease and desist their sales contending that such storefronts are operating as unlicensed pharmacies.

Bipartisan Senate Plan in Works for Seniors Prescription Insurance Coverage

June 5, 2003 - Senators Max Baucus, D-Montana and Charles Grassley, R-Iowa, leading members of the Senate Finance Committee, today outlined a new measure designed for seniors that would offer preventive health coverage as well as protection against catastrophic health care expenses, neither of which is currently available under the government-run program.

The benefit would be the same for everyone, whether in traditional Medicare or in the enhanced Medicare they're working on. Starting in 2004, beneficiaries would be eligible for a discount card that would allow them to purchase prescription drugs at a discount. Two years later, the insurance coverage would begin.

Under the proposed plan beneficiaries enrolled in traditional Medicare could purchase stand-alone drug coverage for a premium of about $35 a month. The plan would have a deductible of $275, after which the individual would pay 50 percent of the bill until total costs reached $3,450. From $3,451 to $5,300 the individual would pay 100 percent of the bill. For all prescription costs beyond $5,300 the plan would pay 90 percent, and the individual 10 percent.

While it is unknown at this point to what degree this measure will receive support it is nevertheless a positive sign that our representatives are working on initiatives that would help to alleviate the burden that many face as a result of the high cost of prescription medications. The panel will be meeting again on June 12th to vote on the measure.

Medi-Save Storefront Closes Its Doors

June 3, 2003 - After initially planning to remain open after receiving a letter from the Tennessee Board of Pharmacy (see story below) Medi-Save has decided to close its doors, at least temporarily.

The storefront operation, which facilitated customers wishing to purchase Canadian prescription drugs, had been open for only one day before they received the letter telling them to cease and desist from this practice. Apparently their operation was further compromised because they had not yet been issued with business licenses from either the city of Knoxville or Knox county.

Tennessee Pharmacy Board Gets Tough with Storefront

June 3, 2003 - The Board of Pharmacy in Tennessee has sent a letter to a newly opened store in the Knoxville area which facilitates prescription ordering from a Canadian pharmacy telling them to cease and desist from this practice.

The storefront, called Medi-Save, just opened up last week and had been actively promoting their new business when they received this letter yesterday. Medi-Save feels that the letter does not hold the same weight as an actual court order and they intend to remain in operation while the legality issues are sorted out.

It will be interesting to see how these battles between storefront prescription facilitators and officials in each of the states work out in the coming months. Just last week the State Attorney's office for Palm Beach County in Florida, after investigating a number of similar storefront operations in their jurisdiction came to the conclusion that these stores were not doing anything illegal in that they didn't actually handle any drugs nor did they give out pharmaceutical advice to customers.

American purchases of prescription medications from outside the country represent less than half of one percent of total medication purchases in the country. The FDA and pharmaceutical industry didn't seem to be too concerned when these orders were restricted only to personal internet purchases or from people actually visiting the other countries to make their purchases. But, in recent months, storefront facilitators have been opening up all over the country and this appears to have the pharmaceutical industry concerned.

Perhaps if out-of-country prescription purchases had remained strictly a personal matter, with people ordering directly from their homes, the industry may not have become as anxious as they appear today. But if storefront operations which act as facilitators of these purchases continue to proliferate then local pharmacies could well begin losing greater and greater percentages of their sales volumes to such storefronts.

Drug Industry Lobbyists Gearing Up to Spend Millions

May 31, 2003 - Read article in the New York Times

Canadian Law May Be Answer to Drug Importation "Problem"

May 30, 2003 - If a Canadian law could be found or if one could be crafted and passed which would legislate against the exportation of prescription medications to the U.S. then American federal and state officials would be off the hook with regard to the "problem" of seniors and low income citizens without drug coverage purchasing their medications from Canadian internet pharmacies.

As it stands, officials are being pressured on one side by the American pharmaceutical industry to put a halt to these importations and on the other side by American advocacy groups who are demanding that this avenue remain available to citizens, many of whom would otherwise go without these often life-saving medications because of the high expense.

If a Canadian law could be brought into effect then American officials would be able to say, "Don't blame us, it's Canadian law." The only other somewhat palatable way of stopping these imports would be on the basis of the "safety" issue. If a "Canadian law" solution can't be found then the only other solution is to cease the drug importation practice for the reason that the FDA cannot ensure the safety of medicines dispensed by pharmacies outside of its control. Canadian prescription dispensing is controlled by Health Canada, the Canadian equivalent to the FDA.

The only problem with the "safety" issue is that it isn't an issue. Americans have been importing Health Canada approved medications for years already and there has not been even one incidence reported where any harm occurred to an American citizen using these medicines. Health Canada drug safety laws are applicable whether the medications are to be consumed in Canada or anywhere else.

So the easiest, politically correct way to end pharmaceutical importations from Canada is for Canadian authorities to either find an existing law or come up with a new law that would stop exports from the country. In Canada, the lobby on such a law may be virtually one-sided as the American seniors and low income advocacy groups do not typically make their views known or appeal to foreign governments.

There are, however, reasons why Canadian authorities may give due consideration to American citizens' concerns. There are countless stories of American seniors who previously had to choose between life-saving drugs and the basic necessities of life prior to their having access to lower priced drugs from Canada. Americans can send a message to Canadian authorities appealing to their compassionate side.

Another message that can be sent concerns the Canadian national pocketbook. Canada loves American tourists and many of those tourists are seniors. Some seniors may get angered with Canadian authorities if they restrict drug exports to the U.S. and decide not to travel to Canada in the future. Other Americans may not have any money to travel to Canada given that any extra money they used to have would now be spent of costly prescription medicines if Canadian drug export restrictions were put in place.

Anyone who wishes to state their position to Health Canada regarding this situation can do so here.

Pharmaceutical operations are also regulated by each province and territory in Canada. There are 11 such provincial and territorial pharmaceutical regulatory bodies that together form the National Association of Pharmacy Regulatory Authorities (NAPRA). Each one of these provincial and territorial regulatory bodies have the authority to disallow exports from their own province or territory. You can let your feelings be known to the national body by emailing them at info@napra.ca

If you currently receive your prescription medicine from a pharmacy in the province of British Columbia and you want this avenue to remain available to you in the future you can contact the College of Pharmacists of British Columbia to state your position at info@bcpharmacy.ca

Mark Up a Victory for Florida Seniors

May 29, 2003 - The State Attorney's office for Palm Beach County has determined that storefront operations facilitating the purchase of medications from Canadian pharmacies are not doing anything illegal.

Their office has been investigating the storefront operations based on complaints received from local pharmacies complaining that they were losing business to these facilitators. The investigation sought to determine whether or not the storefront operations were acting as "unlicensed pharmacies" however it was determined that the stores carried no drugs and also offered no pharmaceutical advice to customers.

While the state health department continues to warn people that they cannot guarantee the safety of medications purchased from Canadian pharmacies there have been no reports of anyone being harmed by using medicines ordered from licensed pharmacists in Canada over the internet. Health Canada enforces strict rules regarding the dispensing of pharmaceuticals regardless of whether they are to be consumed in Canada or anywhere else.

While state and federal authorities have been under considerable pressure from the American pharmaceutical industry to curtail the practice of allowing citizens to purchase their medications from Canada they have been under even greater pressure from advocacy groups representing seniors and other low income Americans to allow this process to continue.

Mark Up a Victory for New Jersey Seniors

May 23, 2003 - An amendment to a bill being considered in the New Jersey state Assembly that would have prohibited citizens from importing less expensive medications from Canada has been removed.

Advocacy groups representing low income citizens without drug insurance coverage were outraged when this proposed drug import ban was added to the bill last week. Had the amendment been left as part of the bill and if the bill was passed, New Jersey would have become the first state to actually legislate a ban on Canadian medicine imports.

Rhode Island House Approves Anguilla Bill on Canadian Prescription Imports

May 14, 2003 - In an attempt to address the high cost of prescription drugs, and in conjunction with the Rhode Island Medical Society, Rep. Fausto C. Anguilla (D-Dist. 68) of Bristol and Warren sponsored legislation this session to allow Rhode Islanders access to lower-priced drugs from Canadian pharmacies.

The House of Representatives today unanimously approved that bill and sent it to the Senate for its consideration.

"Americans are paying two, three or even four times as much for their prescriptions as residents of Canada," said Representative Anguilla upon introduction of the bill. "My preference to correct that disparity would be for prices in the American marketplace to be lower. Until that changes and some un-inflated reality comes to the price of pharmaceuticals, Americans need options."

"My constituents are very concerned about the cost of drugs," said Representative Anguilla. "That is why I introduced a similar bill last session and re-introduced the bill and worked hard for it this year. I am pleased to have the assistance of the Rhode Island Medical Society on this consumer-friendly legislation. Rhode Islanders should have the choice to purchase pharmaceuticals at the lowest possible price."

"Every day patients in Rhode Island face the very real difficulty of how to pay for the prescription drugs that their doctors have prescribed for them," said Dr. K. Nicholas Tsiongas, President of the RI Medical Society. "If the cost of the drug prohibits or compromises our patients' ability to follow the prescribed drug therapy, then we must do something to help them."

"We cannot solve the (drug) price disparity in our General Assembly. This bill is the next best way to get affordable drugs to the patients who need them the most," said Dr. Tsiongas.

The Anguilla bill (2003 - H5478A) is co-sponsored by Rep. Elizabeth M. Dennigan (D-Dist. 62) of East Providence and Pawtucket; Rep. Brian Patrick Kennedy (D-Dist. 38) of Hopkinton and Westerly; Rep. Robert E. Flaherty (D-Dist. 23) of Warwick, and Rep. Paul E. Moura (D-Dist. 2) of Providence and East Providence.

American/Canadian Pharmacy Associations Warn Consumers of Imported Drugs

May 13, 2003 - CNW - Today, the American Pharmacists Association (APhA) joined with 44 other U.S. pharmacist groups and the Canadian Pharmacists Association (CPhA) to endorse a landmark Cross-Border Communique between the U.S.-based National Association of Boards of Pharmacy (NABP) and the Canadian National Association of Pharmacy Regulatory Authorities (NAPRA) on the issue of cross-border importation of prescription drugs.

"The U.S. and Canada each have regulatory systems in place to protect consumers," stated John A. Gans, PharmD, Executive Vice President of APhA. Gans noted that not all medications sold under the Canadian flag -- e.g., via Internet pharmacies claiming to operate in Canada -- actually originate in Canada. Such products could be contaminated or could have been degraded due to poor storage and shipment conditions, or could even be counterfeit altogether.

Jeff Poston, Executive Director of CPhA while emphasizing the integrity of the Canadian drug supply, as did his U.S. counterpart, acknowledged that, "With the Internet, it's definitely a buyer-beware situation. There is no substitute for the pharmacist-patient relationship in securing effective medication management. Some of the Web sites may not be pharmacies at all, in that no licensed pharmacist is at the helm."

Gans added that, "Cheaper isn't better, if the price-tag includes compromising patient safety. Taking the pharmacist out of the picture -- a situation directly related to, and worsened by, illegal importation -- is something we all agree is harmful."

When Americans are ordering their prescriptions from Canada over the internet they should ensure that the drugs are being dispensed by a fully licensed Canadian pharmacist.

"Safety Concerns" the Strategy of Anti-import Proponents

May 11, 2003 - In the battle to stop imports of lower priced prescription medicines into the US there is a recurring theme that is usually put forward. The recurring theme is that federal and state authorities cannot guarantee the safety of the drugs imported from other countries which operate outside of federal and state law and safety requirements.

It's not that Canada does not have strict guidlines with regard to the manufacture and distribution of pharmaceuticals themselves but rather that they obviously are not responsible to report to US federal and state authorities. The fact is that Canadian law requires pharmacies filling prescription orders from Americans, or anyone else for that matter, to supply drugs with a formulation that matches their prescription. Health Canada is the Canadian pharmaceutical watchdog similar to the FDA in the US.

But more and more we are hearing that authorities are having concerns over the safety of imported medicines due to the fact that they have no opportunity to inspect these drug deliveries at federal or state facilities and therefore cannot guarantee their safety. While this may be the case, there has not been one incidence reported where a medicine shipped from a Canadian pharmacy did harm to an American consumer, many of whom have obviously decided to trust Canadian inspection and distribution systems.

Health Canada Approves New Diabetes Related Kidney Disease Drug

May 7, 2003 - CNW - Health Canada has approved the drug COZAAR(R) (losartan potassium) to delay the progression of kidney disease in people with type 2 diabetes, kidney disease and high blood pressure. Losartan continues to be indicated for the treatment of high blood pressure.

The new indication is based on the results of the landmark RENAAL study, published in the New England Journal of Medicine, in September 2001. The study demonstrated that treatment with losartan, an angiotensin II receptor antagonist (AIIA), significantly delayed the progression of kidney disease as measured by the incidence of doubling of serum creatinine (a marker indicating more than 50 per cent loss of kidney function), end-stage renal disease (the need for long-term dialysis or kidney transplantation for survival), or death.

In RENAAL, losartan also demonstrated a significant reduction in proteinuria and a cardio-protective benefit by significantly reducing the rate of first hospitalization for heart failure in this patient population.

"With no proven treatments for delaying end-stage renal disease available on the market, we are very pleased to now have losartan as a new tool to combat this debilitating and potentially fatal disease in people with type 2 diabetes, kidney disease and high blood pressure," said Dr. Scholey, staff nephrologist at the Toronto General Hospital, as well as professor of medicine in the Department of Medicine at the University of Toronto. "End-stage renal disease, the point at which the kidney ceases to function, is costly both in terms of quality of life and health care dollars."

Sanders Calls for Prohibitions on Limiting Canadian Drug Supplies

May 6, 2003 - At a morning Burlington press conference today, Representative Bernard Sanders, the first member of Congress to take constituents over the Canadian border to purchase lower-priced prescription drugs, called on Congress to take a stand against companies who are discriminating against American consumers.

Sanders strongly criticized the drug industry for gouging American consumers, "The drug pricing policies of the pharmaceutical industry are a serious threat to patients here in the United States, who are forced to pay up to ten times more for the same medicines than do consumers in Canada. Unfortunately, the Bush Administration appears more interested in protecting the profits of the drug industry than the well being of American seniors and others who are in desperate need of affordable medicine."

This year GlaxoSmithKline, one of the largest pharmaceutical companies, began limiting their supplies to Canada in order to prohibit pharmacies there from selling their products back into the United States. More recently, AstraZeneca, another major drug company has started limiting their drug sales to Canada as well. Further, the Bush Administration's FDA has begun threatening businesses who are helping Americans purchase low cost prescription drugs in Canada.

In response to these implied sanctions, on February 27, 2003, Congressman Sanders, along with co-sponsors Rep. Dan Burton (R-IN) and Rep. Joseph Crowley (D-NY), introduced the tripartisan bill H.R. 847, "Preserving Access to Safe Affordable Canadian Medicines Act of 2003" to prohibit drug companies from limiting supplies or otherwise interfering with U.S. consumers who purchase medicines in Canada. Sanders is working on other legislation as well, in addition to helping to hold hearings in Congress on this issue.

Sanders concluded, "The real, long-term solution to this issue is not everyone running across the border to buy medicine in Canada. My goal is to see the pharmaceutical industry substantially lower the cost of prescription drugs in this country so that Americans are not forced to pay significantly more than the people of other countries. Further, we need to pass a strong prescription drug benefit under Medicare. But in the meantime, until we are successful in accomplishing that goal, Americans cannot be denied the opportunity of purchasing safe and affordable medicine in Canada."

Congresspersons in Favor of Prescription Re-importation

May 6, 2003 - Congressman Gil Gutknecht, along with his colleagues Congressman Jack Kingston of Georgia and Congresswoman Jo Ann Emerson of Missouri, have formed the Republican Caucus for Affordable Pharmaceuticals (RCAP). The group will be a conduit for Republican Representatives to voice their concerns and seek solutions to one of our nation's most pervasive problems - high prescription drug prices. As a point of gravity for the House's efforts to reduce the price of prescription drugs in America, the Republican Caucus for Affordable Pharmaceuticals will be a resource and a rallying point.

The RCAP say that only closed markets stand between Americans and affordable prescription drugs. They say that we can, however, open markets by "allowing our constituents access to FDA-approved pharmaceuticals, made in FDA-approved facilities, from abroad."

The Congressional Budget Office (CBO) estimates that Americans over 65 will spend $1.8 Trillion on prescription drugs over the next ten years (CBO Testimony, Director Dan Crippen, March 7, 2002). Importing prescription drugs from abroad can lower prices at least 35 percent, or $630,000,000 of savings from the CBO estimate.

South Dakota Warns Storefront Operation

May 5, 2003 - The South Dakota State Board of Pharmacies has told a businessman operating a Canadian prescription order service in Watertown called Dakota Canadian Discount Medical to discontinue the service.

The State Board consulted with the Federal Drug Administration who apparently told them that it was illegal to "advise" people about drugs unless one is a licensed pharmacist.

The warning came by way of a telephone call and the storefront, believing that it is not breaking any laws, has decided it will stay in operation until it receives official documentation ordering it to shut down.

Seniors and other with no drug insurance have for years been able to order their prescriptions from Canadian pharmacies over the internet and have them delivered directly to their homes. But, in recent months, storefront operatings have been opening up throughout the country offering the same ability to acquire less expensive medications from Canada to people who don't have internet access.

Up to 65 million Americans lack insurance for medicines, including about one-third of the estimated 40 million senior citizens and people with disabilities on Medicare, which doesn't cover prescription drugs. The Bush administration and Congress have talked about adding a Medicare drug benefit, but have yet to do so.

The FDA has apparently chosen, at least for the time being, not to put a stop to individuals ordering their medications over the internet for fear of a major backlash from angry seniors. But there does appear to be a great deal of concern from state and federal officials over the emergence of these new storefront operations which facilitate the practice.

Pharmaceutical Companies Offer Discounts

May 3, 2003 - In an apparent effort to stem the increasing practice of American seniors and low income individuals purchasing their medications at often enormous discounts from Canadian pharmacies many pharmaceutical companies have started offering discounts themselves to people who meet their qualifications.

The companies accept applications from individuals who can prove that their income falls below standards which vary from company to company. If the individuals meet these income standards they are issued with prescription drug discount cards which they can present to local pharmacies when purchasing their prescriptions.

The pharmaceutical companies appear to be frustrated by the inaction of state and federal authorities to put a stop to people purchasing their prescription medications from Canada and hope that people will opt to use these discount cards rather than continue with their Canadian medication purchases.

Medco Health Solutions, Inc., a subsidiary of Merck & Co., Inc., operates a plan called the YOURxPLAN which costs $25 per year for an individual and $40.00 per year for a family to join. People who qualify to join can realize substantial savings from the prices that they would normally pay without the card.

GlaxoSmithKline has a discount card called The Orange Card for low-income seniors who have no prescription coverage. Those eligible are senior citizens age 65 and older and the disabled who are enrolled in Medicare and who have annual incomes at or below 300% of the federal poverty level (annual incomes at or below $26,000 single or $35,000 for a couple)5 and lack public or private insurance programs or other pharmaceutical benefit programs, such as Medicaid.

Pfizer Inc. operates a discount program called the Pfizer for Living Share Card. To be eligible for the free Pfizer card, your income must be below $18,000 as an individual or $24,000 as a couple and be enrolled in Medicare .

Another discount card program, called Together Rx, is actually sponsored by 8 pharmaceutical companies. The income guidelines for this program make the card available only to seniors making less than 300 percent of the federal poverty level.

While discounts offered by Canadian pharmacies selling over the internet are still, for the most part, less expensive than the prices of medications purchased using these discount cards, many seniors and lower income individuals don't have access to the internet so these cards will offer them at least some discount from what they would otherwise have to pay.

Federal District Court Upholds GlaxoSmithKline Ceftin Patent

May 2, 2003 - CNW - GlaxoSmithKline today announced that a federal judge for the United States District Court for the Northern District of Illinois in Chicago has ruled in patent litigation involving GSK's drug Ceftin(R) (cefuroxime axetil), a member of the cephalosporin class of antibiotics. Judge Robert W. Gettleman ruled in GSK's favour, saying two patents in question are valid and would be infringed by the product which Apotex plans to market. He said the infringement was willful and GSK is entitled to its costs and attorneys' fees.

One of the patents claims an amorphous form of cefuroxime axetil and the other claims a spray drying process. The patents do not expire until July 2003.

The ruling means Apotex cannot launch a generic form of Ceftin in the U.S. until the patents expire. Another generic company, Ranbaxy, launched its generic form of Ceftin in March 2002. GSK filed suit against Ranbaxy and that trial is set for July 8, 2003, in New Jersey.

Chain Drug Stores Meet to Discuss Canadian Drug Importation

April 30, 2003 - Although American consumption of foreign imports of prescription drugs represents less than 0.4% of the total U.S. drug market, the National Association of Chain Drug Stores is showing concern as such purchases take a nibble out of their member drug stores sales. The Association took up this issue at its annual meeting held in Florida this week.

For some time now, seniors and other low income citizens without drug insurance have been taking advantage of the huge savings that are often possible by purchasing their prescription medications from foreign pharmacies. NACDS has been working diligently on this issue, both through their government relations department in Washington, and as part of the Cross Border Pharmacy Working Group, a coalition convened to devise a strategy to stop the "illegal" flow of foreign drugs into the U.S. market.

One of the issues raised by those opposed to the importation of foreign prescription medications is that there is no guarantee as to the "safety" of these drugs. But Mr. William K. Hubbard, FDA Associate Commissioner of Policy and Planning, in testimony before the House Government Reform Subcommittee on Human Rights and Wellness earlier this month stated that he could not cite one example of a medicine shipped from a Canadian pharmacy which did harm to an American consumer.

Federal and State legislators, while rattling their sabers over this issue, appear to be somewhat reluctant to actually put a complete stop to the importation of less expensive medications from Canada fearing a backlash from angry seniors.

New Storefront Opens in Florida

April 29, 2003 - Bucking threats from the Food and Drug Administration, another discount prescription outlet storefront operation has opened up shop in Florida, this time in Citrus County.

The new store, called Can-Save RX, allows people to bring in their prescriptions from American doctors and have them processed through a licensed Canadian pharmacist in Winnipeg, Manitoba.

While the FDA has long turned a blind eye to individuals purchasing their personal prescriptions in Canada either over the internet or by actually travelling to the country they are frowning on American storefront operations that facilitate this practice.

U.S. Foreign Prescription Purchases Very Small for Now

April 22, 2003 - Business Wire - Jupiter Research, a division of Jupitermedia Corporation (Nasdaq: JUPM), estimates that U.S. consumers spent $700 million online to purchase prescription drugs from foreign online pharmacies, including Canada, in 2002. While sizable, this amount represents less than 0.4% of the total U.S. drug market. Among other factors, unanswered promises of drug benefits for seniors and the uninsured are likely to keep FDA enforcement to a minimum, leading to increased growth of this market mainly through online storefronts.

Based on a March 2003 consumer survey fielded by Jupiter Research, Jupiter Research's new report "Foreign Online Pharmacies: Sizing the U.S. Market for Imported Prescription Drugs" found that less than 3% of online chronic drug users purchase prescription drugs directly from foreign online pharmacies. The current threat to the U.S. prescription drug market is limited because inadequately insured seniors and low-wage workers -- the consumers with the greatest motivation to seek out low-cost drugs -- are underrepresented online. However, kiosk-facilitated channels pose the most immediate threat to U.S. prescription drug sales; inexperienced online consumers and some offline consumers use these online storefronts to process their prescriptions to save costs. According to Monique Levy, Analyst at Jupiter Research, "Although the current market size for cheap prescription drug imports is less than 0.4% of the overall market, the biggest worry to U.S. pharmaceutical manufacturers and retail pharmacies is the potential of the kiosk and Internet cafe-facilitated channel because of lax enforcement by the FDA."

Given the political sensitivity of drug benefits for seniors it is likely that FDA enforcement will be minimal, despite the strong influence of the pharmaceutical lobby. The most effective lever that U.S. pharmaceutical manufacturers have for limiting foreign trade is to continue to restrict supply for example to Canadian wholesalers. "Defining the potential growth of this market will be unclear until conflicting political, commercial, legal and consumer interests are resolved," stated Levy.

HDMA Applauds AstraZeneca

April 22, 2003 - PRNewswire - Healthcare Distribution Management Association (HDMA) applauds AstraZeneca's recent notification to wholesalers and pharmacies in Canada that it will establish a new allotment program to ensure that increased sales are not affecting Canadian citizens access to drugs. AstraZeneca is one the world's largest pharmaceutical drug manufacturers and an HDMA member.

HDMA applauds the actions of AstraZeneca, and as earlier reported GlaxoSmithKline, as an important step in combating the incidence of counterfeit drugs entering the U.S. supply chain. In spite of HDMA's and the industry's concerted efforts to create a closed distribution system to assure patient safety, some U.S. patients rely on foreign Internet pharmacies to fill their prescriptions. Many of these Internet pharmacies operate in countries where the incidence of counterfeit products is extraordinarily high. HDMA supports additional FDA funding to address the incidence of counterfeit drugs reaching U.S. patients via these Internet pharmacies. In addition HDMA's Product Safety Task Force is working on industry guidelines for the industry to ensure the safe purchase of products.

Recently, the Food and Drug Administration (FDA), and the states of Florida, Oklahoma and Tennessee have begun to take enforcement against Canadian prescription storefronts in the United States including sending letters to "cease and desist" the illegal activity of importing drugs from a foreign country.

"HDMA is proud of these HDMA members who have taken these important steps toward combating counterfeiting, and we hope that other manufacturers will soon follow suit," said Ronald Streck, chief executive officer, HDMA. "HDMA and its Product Safety Task Force are committed to reducing the incidence of counterfeit drugs in the U.S. supply chain to ensure patient safety."

Glaxo Under Fire Again Over Medication Pricing

April 21, 2003 - PRNewswire - AIDS Healthcare Foundation (AHF) today has filed an amended federal patent piracy case in United States Federal Court for Central District of California (Western Division) against British drug giant GlaxoSmithKline plc (GSK) over the patent for AZT, the first AIDS drug, and other subsequent derivative AIDS drugs. AHF's initial complaint had been dismissed in March 2003, "without prejudice," allowing the nation's largest AIDS organization to amend and re-file its action against GSK.

"Despite GlaxoSmithKline's attempts to dismiss our lawsuit as 'frivolous' our complaint is very serious, indeed," said Michael Weinstein, AIDS Healthcare Foundation President. "The dominos are falling: Wellbutrin, Paxil, Augmentin, and soon, AZT. Legal gymnastics are not a substitute for actually inventing drugs and charging fair prices for them."

The initial anti-trust lawsuit was first filed on July 1st 2002 in the United States Federal Court for Central District of California (Western Division, Case No. 02-5223 TJH Ex). AIDS Healthcare Foundation -- represented by the law firm of Manatt Phelps & Phillips -- challenged the pharmaceutical giant's patents and their right to exclude competition in the markets for its anti-viral prescription drugs AZT, Ziagen and 3TC and to price these drugs well above competitive rates. GlaxoSmithKline (GSK) controls 40% of the lucrative U.S. AIDS drug market. Glaxo's current worldwide market for its AIDS medications is estimated to be approximately $5 billion dollars annually. Combivir and Trizivir, Glaxo's best selling AIDS drugs today, are reformulations of existing AIDS drugs that offer patients the convenience of two-in-one and three-in-one pill dosing.

The amended complaint filed today in California removes Bayh-Dole Act claims from the initial complaint and concentrates on the patents for AZT and subsequent derivative AIDS drugs and GSK's monopolization of the market for these life-saving drugs. The drugs in the complaint include AZT, Abacavir, 3TC, Combivir and Trizivir.

AHF -- a non-profit that provides medical services to over 12,000 with HIV/AIDS in the U.S., Africa and Honduras -- is suing for damages created by artificially high prices for these AIDS drugs. "It's patent piracy that has cost untold numbers their lives and is denying treatment to millions today," said Weinstein, "all in the name of corporate greed."

Glaxo, long under fire by AIDS advocates over its AIDS drug pricing and policies, has also recently been under intense public scrutiny for blacklisting Canadian pharmacists who sell to US seniors via the internet. In addition, groups including the governments of Japan, Italy and the U.S. are also now investigating Glaxo for bribery, tax evasion, corruption and fraud. The attorneys general of both Connecticut and New York have also filed suit against Glaxo for Medicaid pricing fraud.

The amended patent piracy lawsuit against GSK was filed in United States Federal Court for Central District of California (Western Division) on Friday April 18, 2003. Manatt attorneys Ronald S. Katz, Robert D. Becker, J. Bruce McCubbrey and Noel S. Cohen represent AHF in this action.

New Pharmacy Storefront Opens in California

April 16, 2003 - A new pharmacy storefront operation was opened up this week in San Leandro, California. Bucking warnings from both federal and state authorities that they may be doing something illegal the new storefront, called American Drug Club Oakland, is offering to facilitate people who need to access lower priced prescriptions from Canada.

People with internet access have been able to access medications costing up to 80% less than U.S. prices for some time now but many people, especially seniors, don't have access to the internet themselves. This is where storefront operations like American Drug Club come in. Seniors and others without drug coverage who don't have internet access can simply walk into their store and have them send in the internet order.

The California Board of Pharmacy is not too happy with American Drug Club and others like them contending that it's illegal for Americans to buy their drugs from foreign pharmacies because those pharmacies do not follow the exact guidelines established by the U.S. Food and Drug Administration.

American Drug Club doesn't actually stock any medications at all and doesn't even accept payment for the orders. All it does is offer the same access to lower priced medications that those with internet access have been enjoying for years. The drugs are delivered directly to the customer's home.

The FDA has previously admitted it doesn't have the inclination to go after individual citizens buying Canadian prescription drugs for personal use. But while it has stayed away from personal internet purchases, the FDA announced in February that it is cracking down on storefront operations that try to make money by helping people buy drugs that fall outside its regulation.

These operations have started showing up all across the country in recent months. Late last month, the FDA issued a warning letter to a company called Rx Depot Inc. of Lowell, Arkansas, accusing it of being illegal and posing a risk to the public. The FDA also lent its support to state action against the same company in Oklahoma.

AstraZeneca Plans to Limit Canadian Sales

April 15, 2003 - U.S. drug manufacturer AstraZeneca has sent a letter to Canadian phamaceutical wholesalers and retailers indicating that it has plans to begin an allotment program due to increases in demand for many of its products.

Some time ago, an allotment strategy was put into place by drug giant GlaxoSmithKline in an attempt to prevent Canadian pharmacies from selling their products back into the U.S. American seniors and other lower income citizens without drug insurance coverage have for some time now been able to access lower priced prescription drugs from Canada either by travelling to the country or by ordering over the internet.

AstraZeneca have not stated that preventing Canadian sales to the U.S. is behind this move but rather that they are concerned about "supply problems" and backlogs. Whatever their reasons, the effects will be the same as with Glaxo in that these drugs will become unavailable for lower income Americans wanting to purchase them on the internet from Canadian pharmacies.

So far there has been no official response to this move of AstraZeneca by Congressman Dan Burton, Chairman of the House Government Reform Subcommittee on Human Rights and Wellness who have previously expressed displeasure with GlaxoSmithKline's efforts to cut off access to much less expensive Canadian medicines for American seniors and others without medicine insurance coverage.

The affected drugs manufactured by AstraZeneca include hearthburn medications Nexium and Losec(Prilosec in the U.S), the prostate cancer drug Casodex and the breast cancer treatment Arimidex.

Fifty Percent of Internet Pharmacies Not Licensed

April 7, 2003 - PRNewswire - PharmacyChecker.com, a new website that evaluates online pharmacies and compares their prices, finds that only 50% of the pharmacy sites it has evaluated dispense through a licensed pharmacy. The U.S. Food and Drug Administration (FDA) has cautioned that consumers using unlicensed online pharmacies may receive poor quality or incorrectly dispensed medications.

Tod Cooperman, M.D., President of PharmacyChecker.com said, "Americans are flocking to foreign online pharmacies to save money but often without knowledge of who these companies are, how they operate, and whether they offer the best prices. PharmacyChecker.com's information will help consumers avoid unnecessary risks and maximize their savings." Dr. Cooperman is also the founder ConsumerLab.com, a popular site for evaluating brands of dietary supplements and nutritional products.

PharmacyChecker.com evaluates pharmacy sites based on five objective criteria. Among the twelve sites already evaluated, only five have received the highest rating. The following shows the percentage of sites satisfying each of PharmacyChecker.com's criteria:

PharmacyChecker.com also maintains a continually updated, comparative database of drug prices from the pharmacy sites it evaluates. Analysis of current prices shows:

Dr. Cooperman offered the following tips to consumers: "Canadian pharmacy sites can save Americans a great deal of money, particularly when an order includes multiple prescriptions. However, some Canadian sites are more qualified than others. If you want to stay with U.S. sites, it pays to compare prices, even among well-known, licensed sites. If you are seeking medication without a prescription, which is risky, there are unlicensed Mexican sites with prices comparable to licensed U.S. sites and there are many heavily promoted, unlicensed U.S. sites but their prices are the highest of all."

International Prescription Drug Parity:
Are Americans Being Protected Or Gouged?

April 4, 2003 - Congressman Dan Burton Chairman of the House Government Reform Subcommittee on Human Rights and Wellness, held a hearing yesterday entitled, “International Prescription Drug Parity: Are Americans Being Protected or Gouged?”

With approximately 108 million Americans managing at least one chronic health condition such as heart disease, diabetes, asthma, or high blood pressure - dependence on prescription drugs has risen dramatically in the United States. In order to avoid the higher prices in the U.S. marketplace, an estimated 1 million American consumers now purchase between $500 Million and $1 Billion dollars worth of prescription drugs from Canadian pharmacies annually. The U.S. Food and Drug Administration (FDA) estimates that more than 2 million shipments of prescription drugs will cross the border from Canada into the U.S. this year.

Burton said, “Drug manufacturers like GlaxoSmithKline, a leading pharmaceutical company in the international drug market, have long been charging substantially more, in some cases up to 90% more, for their products in the United States than in Canada. It is important that the estimated 1 million Americans currently buying prescription drugs from Canada continue to enjoy affordable access to the prescription medications they need in order to sustain good health.”

Rep. Bernard Sanders (I-VT), a senior Member of the Committee and the first Member of Congress to accompany U.S. seniors over the border to buy lower-priced medicines in Canada, strongly criticized the drug industry for gouging American consumers, "The drug pricing policies of the pharmaceutical industry are a serious threat to patients here in the United States, who are forced to pay up to ten times more for the same medicines than do consumers in Canada. Unfortunately, the FDA now appears to be working closely with the pharmaceutical industry to put the health of industry profits over the health of American patients."

Sanders is calling for a federal investigation into the number of deaths among the elderly because they couldn't afford life-saving medications. He said he will ask the General Accounting office to conduct a study to provide an estimate of how many Americans are dying because prescription drugs are beyond their financial abilities.

In 2000, Congress overwhelmingly passed - and the President signed into law - legislation that permits U.S. consumers, pharmacists, and wholesalers to purchase FDA-approved prescription drugs on the international market (the “MEDS Act”). However, the law has never been implemented. While the FDA has raised some concern about counterfeit or mislabeled products being marketed in various countries, this is not the case in Canada. In a hearing just last week before the full Committee on Government Reform regarding Internet pharmacies, Mr. William K. Hubbard, FDA Associate Commissioner of Policy and Planning, testified that he could not cite one example of a medicine shipped from a Canadian pharmacy which did harm to an American consumer. Mr. Hubbard had also been invited to testify at yesterday’s Subcommittee hearing.

Hubbard, testifying before the committee, told members his agency cannot guarantee the safety of foreign-bought drugs, and discourages the practice. Hubbard said his agency has investigated Internet companies claiming to sell FDA-approved medications, only to discover they are distributed from overseas, frequently Thailand, where standards of quality are vastly different. "If we don't know where (the Internet companies) are, we don't know where their drugs come from," Hubbard testified.

Rep. Sanders lashed out at Hubbard for using "scare tactics" to discourage Americans from buying Canadian sold drugs -- where standards are on par with those in the U.S., and at significantly lower prices. "You want to educate Americans?" Sanders asked Hubbard rhetorically. "You should put out pamphlets telling Americans to go to Canada for affordable drugs. How about you put out some charts about that."

Committee members accused the federal agency of being influenced by the powerful drug industry, which has 600 lobbyists and has contributed more than $20 million in the past two election cycles. There are currently several pieces of drug reform legislation before Congress. One bill, submitted by Sanders, Burton and Tierney, would fine drugmakers if they discriminate against American consumers who buy medicines in Canada.

 

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