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Thursday, May 31, 2007

Identifying the Drug Safety Problem at FDA

An article in today's New York Times follows up on the controversy of another botched FDA drug approval (Avandia). With an unfortunately large number of case examples to study, drug safety experts and lawmakers are beginning to come to a consensus on the nature of the problem at FDA.

Common sense would tell us that drug safety and drug approval are inextricable issues. In reality, this is not the case. The Times article discusses how safety is marginalized in the name of expeditious approvals. The resulting organizational culture at FDA is leading to safety mishaps, not to mention some bad blood:

[A Congressional] hearing next week may highlight the growing internal dissension between officials who approve drugs and those who track the safety of drugs after they have been approved. Tension between the groups has long been common, but in recent months it has erupted into sniping.

Congressional investigators said the safety group recommended months ago that the drug agency put its severest warning on Avandia. The review group, which holds sway, has not done so.

Sen. Chuck Grassley (R-IA) attempted to attach a provision to the Senate's recent FDA reform bill which would have addressed this issue. The Grassley amendment would have involved the Office of Surveillance and Epidemiology (safety folks) in post-market safety reviews, instead of leaving all the responsibility to the Office of New Drugs (approval folks). The amendment was rejected 47-46.

There is still a chance for such legislation when the House tackles FDA reform this summer. America needs an FDA focused on proving safety first, not presuming safety first. Stay tuned to Reg•Watch for more.