Senators step in to the drug safety debate

Senators Dodd and Grassley have introduced legislation to establish a Center for Postmarket Drug Evaluation and Research reporting to the FDA Commissioner. The idea is to separate drug approval from ongoing safety monitoring.

According to the Boston Globe, the Center….

…could require safety studies that most drug companies now fail to complete, update drug labels, and alert consumers to high-risk drugs and restrict their use. In extreme cases, the director could ask the FDA commissioner to pull a drug from the market.

A key function of the Center would be to regulate advertising of newly approved drugs and drugs deemed risky. As I’ve written recently, the pharmaceutical industry has been too aggressive in promoting its drugs to some people who don’t really need them, and some of those people have been subjected to unnecessary risk. In my opinion, this is what doomed Bextra and Vioxx and threatens drugs in other classes as well. The best solution for all would be industry self-restraint, but in its absence we can expect legislative remedies that may be heavy handed.

April 28, 2005

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