The Vioxx withdrawal put the Food and Drug Administration (FDA) under the spotlight. There were allegations that the FDA was in cahoots with Merck in keeping Vioxx problems under wraps (see, for example, Will COX-2 Inhibitors Crash and Burn?). A New York Times story reported “Members of Congress, an internal F.D.A. whistleblower and prominent medical journals have said the agency is incapable of uncovering the perils of drugs that have been approved and are in wide distribution.”
Other critics, such as Dr. Angell (see “The Truth About the Drug Companies: What To Do About It“), have broader issues with the FDA. Among the suggestions for revamping the FDA are the following:
- Repeal the Prescription Drug User Fee Act, which authorizes drug companies to pay fees to FDA for each drug reviewed.
- FDA advisory committees should not include experts with financial ties to the drug industry.
- Restructure the FDA to separate the job of monitoring safety of approved drugs from the job of approving drugs in the first place.
- FDA should seek additional authority to suspend the sale of drugs already on the market.
- Improve safety surveillance of approved drugs (e.g., establish patient registries and/or require drug companies to undertake new safety tests once a drug is approved).
Pharma Marketing News is hosting a new survey of pharmaceutical professionals, healthcare professionals, and the general public to get a better idea which reforms, if any, are likely to be at the top of peoples’ lists.
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