Saturday, September 23, 2006

Straightening out the FDA

The Institute of Medicine has found significant management problems in the division within the agency that reviews new drugs. The FDA itself has had extensive executive turnover; no commissioner in the past ten years has served more than two years. Part of the problem with the review process is due to the fact that more than half the money the FDA spends to review the safety of drugs comes from the companies who create the drugs.

The report has a number of recommendations to improve the process of drug review, two of which are obvious: initially approve a drug for a limited time period (five years) and then check it again; punish companies that do not complete safety studies.

Will Congress do anything with this?

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