Washington Editor

WASHINGTON - Pfizer Inc.'s decision to require 46 of 7,200 Canadian pharmacies to purchase drugs directly from the company rather than through wholesalers set off another round of strong criticism against an industry considered greedy by certain consumer groups and politicians who believe Americans pay too much for prescription drugs.

Nevertheless, New York-based Pfizer joins other large pharmaceutical companies, including GlaxoSmithKline plc - the company that started it all - in adopting policies to prevent their products from being exported back into the U.S.

London-based GSK actually got the ball rolling in February when it announced a policy to limit Canadian sales to just enough product to support the needs of Canadians. (See BioWorld Today, Feb. 18, 2003.)

The mere mention of such a plan inflamed Rep. Bernie Sanders (I-Vt.), who makes no secret of his distaste for the drug industry.

Sanders referred to the Pfizer decision as a declaration of war against American senior citizens and the chronically ill. "As a result of Pfizer's actions, many Americans will suffer and some will die," he said in a prepared statement.

Regarding its decision, a Pfizer spokesman referred BioWorld Today to a prepared statement that said: "Pfizer is taking steps to safeguard the integrity of the pharmaceutical supply system by ensuring that its medicines are supplied through authorized channels that meet all regulatory requirements. The company is taking these steps to help protect the safety of patients and ensure an adequate and ongoing supply of Pfizer products."

When GSK announced its plan, Sanders, along with Reps. Joseph Crowley (D-N.Y.) and Dan Burton (R-Ind.), responded with legislation (HR 847) designed to stop GSK and others that would follow by categorizing such business decisions as discriminatory against U.S. consumers. (See BioWorld Today, Feb. 28, 2003.)

In recent weeks, Reps. Gil Gutknecht (R-Minn.) and Jo Ann Emerson (R-Mo.) persuaded a majority (243-186) in the House to support prescription drug reimportation legislation that includes an element meant to stop business tactics like the ones being practiced by Pfizer, a spokesman from Sanders' office told BioWorld Today. (See BioWorld Today, July 28, 2003.)

By way of an agreement with Emerson, the Gutknecht legislation is supposed to become the official position of the House in the Senate-House conference committee discussions on Medicare reform.

The Gutknecht-Emerson reimportation legislation contains what many in the industry refer to as a "poison pill," that is, it eliminates the requirement of Health and Human Services Secretary Tommy Thompson to certify that reimporting FDA-approved drugs from other countries is safe. Previous legislation has included this requirement, which essentially has prevented earlier attempts to be implemented.

One of the strongest arguments against reimportation is that safety cannot be guaranteed.

But Daren Jorgenson, president of the American Drug Club, a Canadian prescription service firm, doesn't buy that argument for a minute.

He told BioWorld Today the FDA and Pfizer can't even guarantee Americans that they're getting safe drugs, referring to the 70,000 90-pill containers of counterfeit Lipitor that recently turned up in U.S. pharmacies.

The American Drug Club claims billions of U.S. dollars worth of Canadian prescriptions have entered the U.S. over the past four years and there's been no evidence of counterfeit drugs, no one has died and research funds have not dried up.

"It's funny how American consumers mandate the FDA to regulate safety issues but the FDA allows this [reimportation] to go on," Jorgenson said, adding that drug companies are now taking it upon themselves to enforce the law.

While reimporting prescription drugs is illegal, the FDA has allowed the practice under certain circumstances, for example, if an AIDS patient needs medication that is not yet approved in the U.S.