Efforts to Overhaul FDA Should Focus on Consumers, Not the Pharmaceutical Industry

By Christine Cupaiuolo — April 17, 2007

Recent bills aimed at overhauling the Food & Drug Administration don’t go far enough in protecting the public from potentially dangerous drugs and medical devices, OBOS Executive Director Judy Norsigian and Diana Zuckerman, president of the National Research Center for Women & Families, argue in an op-ed published in today’s Boston Globe.

Last year, Mike Enzi, a conservative Republican from Wyoming, was in charge of health legislation in the Senate, and [Sen. Edward] Kennedy was in the minority party. The two senators introduced a drug safety bill that pleased the pharmaceutical industry considerably more than consumer advocates. This, supposedly, was the best these advocates could get from a Republican Congress.

The bill was delayed, luckily, and much has happened since then. Kennedy is now in charge of health legislation in the Senate. Nevertheless, he and Enzi introduced the same bill this year.

When drugs are allowed into the market before their side effects are fully evident, the potentially deadly results are all too familiar: think of drugs like Vioxx, Trasylol, and Ketek, and devices such as drug-eluting stents and defibrillators.

Preventing unnecessary deaths will take more congressional muscle. For example, when new drugs are widely advertised to consumers before the risks are known, thousands of those who take them may be harmed. Most could have been treated by older, safer, cheaper drugs. That’s why the American Medical Association, most physicians, and the Institute of Medicine — a respected nonprofit that offers advice on biomedical issues — recommend a two-year moratorium on direct-to-consumer advertising of all new drugs.

That sounds like a great idea, but the Senate bill rejects it. Instead, it would allow (but not require) the FDA commissioner to impose a moratorium only when there is clear evidence that advertising to consumers would harm patients. This is hard to prove because new drugs lack data on widespread use. Even worse, Kennedy’s bill doesn’t even require the FDA to review new drug ads for accuracy.

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