The FDA and Regulatory Capture: What the New Avandia Restrictions Mean

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The FDA yesterday imposed some fairly strong restrictions on the use of the controversial diabetes drug Avandia. The handling of the matter by Obama’s FDA chief, Margaret Hamburg, and her deputy, Joshua Sharfstein, offers one take on the administration’s approach to regulation and it’s not black and white. Those interested in the debate over federal regulation–is it burdensome to business or a necessary protection for consumers–may be interested in our story on Avandia here.

The point of the story was not that the drug was proven dangerous, needed to be pulled and stayed on the market thanks only to regulators who were in the pockets of industry. Rather, we found that the drug maker gamed uncertainty about the drug’s safety to its advantage, sometimes with regulators’ help, sometimes by out-maneuvering them, potentially endangering patients.

What’s interesting about the FDA’s decision yesterday is that it resists the more strident calls for an outright ban on the drug. Use of the drug will be severely restricted, but doctors who find it helpful when other drugs don’t work can weigh the risks in consultation with patients and prescribe it. There are plenty of examples of unnecessary, burdensome or ineffective regulation. And there are plenty of examples of dangerous regulatory capture. In this case, the FDA tried to avoid both.