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Paul Kiesel
Paul Kiesel
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FDA Promises More Focus on Drug Safety

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FDA pledges to improve its safety program. New promises from the FDA.

Last week the Food and Drug Administration promised to make significant changes to the U.S. drug safety program. Its pledge comes as a result of last falls scathing report issued by a blue ribbon panel that found the FDA’s drug safety program is in serious need of change. Specifically, the panel found that FDA officials were more concerned about approving new drugs than investigating risks and requiring follow up to identify serious side effects.

FDA commissioner Andrew von Eschenbach stated that the improvements would assist the agency in regaining the “trust and confidence” of patients and doctors after a series of astounding safety lapses. These lapses included the withdrawal of Vioxx, a popular painkiller, after company sponsored studies confirmed heart attack risks associated with use of the medication. Particiularly embarrassing was the fact that FDA experts had attempted to warn the FDA of Vioxx’s risks but had not been taken seriously.

The FDA now plans to initiate a pilot program to assess the safety record of new drugs 18 months after approval. The program will start with just a small number of medications and the results will be made public.

Last weeks announcement was the second time in two years that the FDA has promised to make changes to its safety program. In 2005, the agency set up a drug safety oversight board.

Agency critics call the new promises too little, too late. It will be up to the new Congress to increase funding and approve an increase in the pharmaceutical industries user fees which would finance new drug safety efforts.

Kiesel Boucher Larson specializes in litigation involving unsafe drugs and works to ensure compensation for those injured by defective drugs.