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Back To Vidyya Former FDA Commissioners Warn Of Dangers Of Drug Reimportation

All Former FDA Commissioners Since 1969 Say Reimportation Is Risky

Eleven Food and Drug Administration Commissioners -- who have served Presidents from Johnson to Clinton -- have written to members of Congress that the reimportation of prescription drugs poses grave risks for American patients.

The letters, from consecutive former commissioners and acting commissioners dating back to 1969, warn that removing the protections in current law regarding reimportation of drugs could expose U.S. patients to dangerous, counterfeit or adulterated medicines.

The reimportation issue is at the forefront of the news because there is legislation pending before a House/Senate conference committee that would overturn a consumer protection law enacted in 1988. The pending legislation would lower safety standards for imported prescription medicines. The conference committee is expected to act quickly in reconciling the House and Senate versions of reimportation legislation. A vote could come in early September.

Michael A. Friedman, M.D., Acting Commissioner in the Clinton Administration (1997-1998), wrote to Senator Orrin Hatch that "the Jeffords amendment adopted in the Senate and the Coburn, Crowley and Gutknecht amendments adopted in the House to the Agriculture appropriations bill would lower safety standards for prescription medicines imported or re-imported into the U.S. ... (T)hese measures would significantly increase risks to patients on prescription medicines because their drugs might be adulterated, counterfeit or sub-potent."

Donald Kennedy, Ph.D., FDA Commissioner under President Carter and current Editor-in-Chief of Science, wrote to Senator Trent Lott, "At a time when science is making new discoveries and consumers are demanding more and better medicines, we should be focusing on efforts to decrease, rather than increase, health and safety risks. The entire thrust of the Jeffords amendment is to relax the standards for medicines imported or re-imported into the U.S. below those applied today by the FDA under the Federal Food, Drug and Cosmetic Act ... If we lowered the safety standards for prescription medicines now, precisely when the use of medicines continues to rise and be more pivotal to health care, the effects on patient health and safety could be 'devastating' ... "

Arthur Hull Hayes, Jr., M.D., FDA Commissioner under President Reagan, wrote to House Minority Leader Richard Gephardt, "After my review of the proposed (Crowley, Coburn and Jeffords amendments) legislation, I am amazed that the Congress would consider emasculating provisions of the Food, Drug & Cosmetic Act and The Prescription Drug Marketing Act. Both these laws were adopted to protect those living in the U.S. from ineffective or unsafe drugs ..."

Alan F. Holmer, President of the Pharmaceutical Research and Manufacturers of America (PhRMA), said that these warnings from former FDA Commissioners should act as a red flag to members of Congress.

"Congress should heed these warnings from people who know the dangers of counterfeit and adulterated drugs and stop this legislation before it can harm American patients," he said.

Other commissioners writing letters to warn of reimportation dangers are: David Kessler, M.D. (Bush, Clinton), James Benson (Bush), Frank Young, M.D., Ph.D. (Reagan, Bush), Mark Novitch, M.D. (Reagan), Jere Goyan, Ph.D. (Carter), Sherwin Gardner (Nixon, Ford, Carter), Charles Edwards, M.D. (Nixon), James Goddard, M.D. (Johnson).

Copies of the letters can be downloaded at the following sites .

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Editor: Susan K. Boyer, RN
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