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Illinois Residents Sue FDA As Debate Over Drug Importation Heats Up

BY Admin  February 26, 2004 at 5:54 PM EDT

Illinois residents Ray and Gaylee Andrews on Thursday filed the suit, which seeks class-action status, in Washington, D.C.

“If this lawsuit succeeds, the state of Illinois can go ahead and import prescription drugs from Canada,” Democratic Gov. Rod Blagojevich told reporters.

The FDA told Reuters it believes the Illinois suit is probably the first of its kind by an individual on the issue.

The suit comes as the debate on the issue of drug importation is heating up on Capitol Hill, where lawmakers who support legalizing drug importation are criticizing Wednesday’s announcement that FDA Commissioner Mark McClellan, a vocal opponent of importing drugs from Canada, will lead a study of the issue.

“It’s unbelievable,” said Sen. Byron Dorgan, D-N.D. “Dr. McClellan has made it known that he believes reimportation is unsafe, which obviously reflects the interests of the pharmaceutical industry. If ever there were a fox in the chicken coop situation, this is it.”

The study is required by the new Medicare law, which left in place government rules that ban the importation of drugs unless Health and Human Services Secretary Tommy Thompson certifies their safety – something he has not done.

Thompson, who chose McClellan to chair the Task Force on Drug Importation, said the commission will determine whether and how drugs could be imported safely from Canada and perhaps other countries.

“The importation of drugs remains a long-standing safety concern for the Department of Health and Human Services, as we currently cannot guarantee the safety of these medicines,” Thompson said.

“This task force will study what it would take in terms of oversight and resources to safely import drugs. It will hear from all sides of the issue in a public, transparent manner. I’m confident that it will produce a balanced picture of the costs and benefits of drug importation.”

McClellan has repeatedly warned that drugs bought from other countries, particularly via the Internet, may be unsafe.

After a January 2004 blitz of inspections of drugs being sent to the United States, McClellan said, “We’re once again alerting consumers of the risks associated with buying medications from foreign sources outside of the safe, regulated systems of the United States and other nations … Compromising safety for price is not in the best interest of the American public.

Disagreements with McClellan over drug importation are threatening to hold up his nomination to head the Centers for Medicare and Medicaid Services, which is responsible for putting into place the sweeping Medicare bill that President Bush signed into law in December.

Dorgan, Sen. John McCain, R-Ariz., and Sen. Debbie Stabenow, D-Mich., said Wednesday that they will delay McClellan’s nomination until he explains to Congress his opposition to importing drugs.

“Will he continue to side with the pharmaceutical industry, or will he be willing to work with us on opening the borders to bring back prescription drugs?” Stabenow asked.

McCain, speaking at the same event, said he felt McClellan had “done a great disservice … by frightening people about drugs in Canada.”

Meanwhile, drug makers are continuing to take matters into their own hands as they attempt to reduce the amount of drugs shipped from Canada to U.S. consumers.

Pfizer Inc. confirmed Thursday it had cut off sales to two Canadian drug wholesalers. The move will make it more difficult for Canada’s Internet pharmacies to buy products made by Pfizer, including the popular cholesterol-lowering drug Lipitor.

Pfizer said the action was designed to protect patient safety, and the company might resume sales to the wholesalers if they could prove they would comply with contract terms.

Pfizer faxed letters Thursday to Praire and to Procurity Pharmacy Services Inc., in which it said they could no longer buy drugs from Pfizer because they had sold the company’s products to unauthorized customers. Pfizer had previously sent a letter to Canadian wholesalers forbidding them to sell its drugs to companies that might be exporting them.