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The FDA

Institute of Medicine report calls for sweeping changes at the FDA

Monday, September 25, 2006 by: Jessica Fraser
Tags: the FDA, Institute of Medicine, drug approval process


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(NewsTarget) A new report by the Institute of Medicine (IOM) calls for major changes within the U.S. Food and Drug Administration (FDA), including restrictions on drug advertising and increased drug safety measures.

The IOM report says the FDA is plagued by internal quarrels, outdated regulations, lack of financing and poor management. FDA panel members report deep concerns about the agency's "organizational heath," as well as its ability to guarantee the safety of the drugs it approves.

The report calls for a number of changes -- most of which would require passage by Congress -- including a requirement that new drugs display a black triangle for two years to warn consumers that the drug's safety is less certain than older drugs; a restriction on drug advertisements for the two years during which drugs display a black triangle; increased authority for the FDA to issue fines, withdrawals and injunctions if drug companies fail to complete safety studies -- which happens frequently; a six-year term for the FDA commissioner; a thorough drug safety review of all drugs at least once every five years; and a requirement that drug firms publicly post the results of nearly all human drug trials.

"This is a damning report of the FDA's utter failure to protect the American public from the profit motives of drug companies," says natural health advocate Mike Adams, author of "The Five Habits of Health Transformation." "But it doesn't go nearly far enough. Any honest FDA reform must include banning all direct-to-consumer drug advertising, conducting criminal investigations into the top decision makers at the FDA, and creating an office of internal affairs at the agency."

The report criticizes the FDA's "lack of stable leadership," since over the past 10 years no commissioner has served more than two years, although the term is open-ended.

"Without stable leadership strongly and visibly committed to drug safety, all other efforts to improve the effectiveness of the agency or position it effectively for the future will be seriously, if not fatally, compromised," the report states.

The IOM report also highlights what it calls one of the FDA's biggest problems: a deal struck in 1992 between Congress and the pharmaceutical industry in which drug firms pay millions in fees to speed up drug reviews. Congress and the drug industry are currently in the process of reauthorizing the 1992 financing deal.

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