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Ex-FDA official endorses bill to legalize prescription-drug imports

WASHINGTON—A bill to legalize prescription-drug imports from Canada and elsewhere would make the practice safer for U.S. consumers, a former Food and Drug Administration commissioner testified Tuesday.

The endorsement by Dr. David Kessler, who headed the FDA under former President George H.W. Bush—President Bush's father—and President Clinton, contrasted with stark warnings from other witnesses who appeared before the Senate Committee on Health, Education, Labor & Pensions. They said the proposed measure would bring more counterfeit drugs into the United States and would slow U.S. drug companies' research and development by cutting into their revenue.

Under the bill, sponsored by Sens. Byron Dorgan, D-N.D., and Olympia Snowe, R-Maine, individuals could buy and import drugs from Canadian pharmacies registered with the FDA, starting 90 days after the legislation passes. One year after enactment, it would permit commercial imports from licensed pharmacies and wholesalers in Canada, the European Union, Switzerland, Australia, New Zealand and Japan. The number of licensed importers would be limited for the first two years.

The bill authorizes imports only of FDA-approved drugs manufactured in FDA-approved facilities.

The measure, and similar legislation by Sen. David Vitter, R-La., is intended to address concern over U.S. drug prices, which are the highest in the world. The FDA currently doesn't seek prosecution of U.S. residents who fill personal prescriptions at Canadian drugstores in person or through mail order and the Internet. But the agency and the drug industry oppose widespread commercial importation, claiming that foreign drugs may be unsafe, counterfeit or improperly labeled, stored and shipped

The Dorgan-Snowe legislation, co-sponsored by Sen. Debbie Stabenow, D-Mich., requires that imported drugs be labeled in English and packed in tamper-proof packages, and that their chain of possession be accounted for from manufacture to distribution. A fee of 1 percent each from drug importers and exporters would fund the safety requirements.

Kessler, who's the dean of the School of Medicine at the University of California, San Francisco, said the bill would make importing drugs safer for consumers, who now do it with almost no government oversight or safety assurance.

"Congress, I believe, has a responsibility to fix this serious problem," Kessler testified. "This legislation goes farther than previous attempts at addressing this issue."

He praised the bill for limiting the number of pharmacies and drug wholesalers that would be eligible to import medications during the first two years. In written testimony, Kessler said Congress "should consider whether similar limits should be included in the legislation for subsequent years, in order to keep the program manageable and of the highest quality."

A 2004 report by the Department of Health and Human Services found that assuring the safety of imported medications would be so costly that consumers would see a price break of only about 1 percent. Legalizing imports also would cut drug-companies' profits, which pay for research and development, resulting in three or four fewer approvals each year of innovative new medications, the report warned.

Several witnesses at the hearing cited other concerns. Thomas Arthur, the dean of the Emory University School of Law in Atlanta, said allowing drug imports was tantamount to importing foreign price controls. Graham Satchwell, who heads a London firm that helps drug companies implement anti-counterfeiting measures, said the United States would be a prime target for counterfeiters if importation were legalized.

Supporters of the bill think the proposal has the votes to pass in the Senate. The idea has had strong support in the House of Representatives in the past.

Senate Majority Leader Bill Frist, R-Tenn, while supporting hearings on the measure, hasn't committed to a full floor vote. Frist's spokeswoman, Amy Call, said the senator supported importation if safety could be assured. She said she was unclear whether he thought the Dorgan-Snowe bill met that test.

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To read the Pharmaceutical Market Access and Drug Safety Act of 2005 online, go to http://thomas.loc.gov/cgi-bin/query/z?c109:S.334:

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(c) 2005, Knight Ridder/Tribune Information Services.

ARCHIVE PHOTOS on KRT Direct (from KRT Photo Service, 202-383-6099): David Kessler

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