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HealthBiz: Canada pharmacies face shortage

By ELLEN BECK, United Press International

WASHINGTON, April 13 (UPI) -- Pharmacies in Canada are running short of key drugs as major pharmaceutical companies punish them for selling to U.S. seniors by cutting off supplies.

"Our pharmacies are under incredible pressure right now. The supply issue is drastic," Dave Mackey, president of the Canadian International Pharmacist Association, told reporters at a briefing Monday. "Unfortunately, the situation is rather dire."

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In January, Pfizer cut off shipments of its drugs to more than 70 Canadian pharmacies that sell to U.S. customers. Company officials, who did not return phone calls by UPI's HealthBiz, have said they are concerned about their Canadian pipeline and that allowing the reimportation of drugs could lead to counterfeit products on the market, resulting in a health safety issue.

Pharmaceutical companies also consider the issue one of intellectual property rights.

Mackey said Pfizer has been joined in what he called "blacklisting" by Eli Lilly, AstraZeneca and other major drugmakers, placing U.S. seniors in a serious predicament trying to afford the prescriptions they need but are too expensive to buy at U.S. pharmacies.

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"If Pfizer is truly interested in helping therapeutically their customers and their patients they wouldn't cold-turkey peel the products from their hands," he said. "We are turning (customers) away."

He said Pfizer's Lipitor is among the drugs in greatest shortage, as pharmacies are drawing down inventories and pharmacists are telling patients to ask their physicians to prescribe an alternative for the cholesterol-lowering medication.

Mackey said Canadian pharmacy sales represent only a 0.5 percent market penetration in the United States, but seniors who desperately need but cannot afford medicines consider the Canadian pipeline crucial.

Meanwhile, Canadians are being asked by a non-profit group called Results for America to document instances in which they they cannot obtain prescription drugs because of supply cutbacks. Consumers can make reports at resultsforamerica.org/health/medmail.php.

Pam Solo, president of the Civil Society Institute in Newton Centre, Mass., 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."

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ON THE OTHER SIDE OF THE ISSUE

The Food and Drug Administration is teaming with the Virginia Pharmacists Association in the "Looks Can Be Deceiving" campaign. More than 1.5 million pieces of consumer educational materials are going to 1,500 pharmacies throughout Virginia, warning about the risks of buying medicines from Canada and other foreign sources that do not fall under FDA regulations.

"The FDA stands firm on our long-held position that importing prescription drugs from Canada and other foreign countries is unsafe," said Thomas J. McGinnis, director of Pharmacy Affairs in FDA's Office of Policy, said in a statement.

The FDA has said its concerns with reimportation of drugs from Canada or buying foreign-made drugs include potential counterfeiting, use of untested substances, lack of quality assurance and the use of drugs without the guidance of a physician.

This campaign already is underway in Illinois, Texas, California and Maryland.


ANOTHER REIMPORTATION TWIST

Canadian healthcare organizations that are opposed to Canadian pharmacies selling medications to U.S. consumers will give their side of the story Wednesday to the Food and Drug Administration's reimportation task force. The task force was set up to look at creating a regulatory process in the United States to allow for the safe reimportation of drugs from Canada and other countries.

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The groups, who claim to represent the interests of millions of Canadian patients, are concerned about what effect reimportation will have on their access to prescription drugs and healthcare providers, as well as Canada's drug pricing system.


SENIORS TRY TO 'PFIX PFIZER'

The Minnesota Senior Federation has begun its "Pfix Pfizer" campaign in protest of the company's decision to cut off supplies of its medications to Canadian pharmacies that fill prescriptions for U.S. seniors.

The protest involves "10 days of Outrage" leading up to Pfizer's annual meeting in St. Louis April 22 and will include protests in St. Louis and at the company's New York headquarters, stockholder resolutions led by Minnesota Gov. Tim Pawlenty, congressional lobbying against Pfizer, potential legal actions through state Attorneys General and a boycott of Pfizer's over-the-counter healthcare products.

Barbara Kaufman, federation president, told reporters during a conference call questioned Pfizer's stated safety concerns over reimported drugs.

"We don't believe them. We think Pfizer is really worried about its profits," she said. "The high cost of American prescriptions can lead to the very problems that Pfizer says it worries about-- increased contaminated or counterfeit pharmaceuticals."

Kate Stahl, Pfix Pfizer campaign leader, said a number of states are participating in events to protest Pfizer's actions and attorneys general in several states are considering legal action.

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Pfizer did not return calls for comment.


PFIZER, MEANWHILE, SUES OVER LIPITOR COPY

Pfizer issued a statement that said it is suing the operators of "look4generics.com," an Internet site it accuses of selling an unapproved copy of of its cholesterol drug Lipitor. The suit, filed in U.S. District Court in Delaware, claims patent and copyright violations and seeks an injunction against further sales of a product called Storvas, which is advertised as being manufactured by Ranbaxy Pharmaceuticals Inc. in India.

Pfizer also asked that references to Lipitor in advertising materials for Storvas be removed, along with computer links that direct patients who might use Lipitor to the other product. Pfizer claims Storvas is not approved by the Food and Drug Administration and therefore is sold illegally in the United States.


FDA SETTLES DRUG REPACKAGING CASE

Phil and Kathy's Inc., of Richton Park, Ill., a drug repackager -- has settled a case with the Food and Drug Administration involving thousands of imported but unapproved drugs seized by the regulatory agency last year.

The company was doing business as Local Repack, Alliance Wholesale Distributor and Local Pharmacy. During a 2003 inspection the FDA found Phil and Kathy's was importing and repacking drug products labeled in Spanish and Portuguese and did not comply with current good manufacturing practice requirements.

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A consent decree signed by the company owners stipulates it is prohibited from manufacturing or repackaging any products until it meets FDA standards.

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