Strange Behavior at the F.D.A.

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Strange Behavior at the F.D.A.

New York Times Editorial, November 15, 2005

Congressional investigators have documented some highly suspect maneuvering behind the Food and Drug Administration's decision last year to reject over-the-counter sales of the controversial morning-after contraceptive known as Plan B. The investigation, by the Government Accountability Office, stopped short of asserting that political considerations had led agency officials to overrule their own experts and outside advisers. But the most plausible inference one can draw is that politics or ideology was allowed to trump science as higher-ups at the agency searched for rationales to keep access to the contraceptive restricted.

The investigators looked only within the F.D.A. and did not consider any communications between agency officials and other parts of the executive branch, so they had no way to determine whether political pressure was exerted from elsewhere. But they did find four unusual aspects of the decision-making process that look hard to justify.

First, directors of the offices that would normally handle the issue disagreed with the decision and did not sign the rejection letter. Second, high-level managers intervened more in this case than in any other case involving a switch from prescription to nonprescription status.

Third, and most shocking, the heads of several key offices said they had been told by high-level management that the switch would be denied months before their reviews of the application were even completed, a contention that high officials deny. Fourth, the rationale used to justify the rejection was a novel one: the agency expressed concern that younger adolescents might engage in unsafe sexual behavior with Plan B available, an age-based criterion never before raised for an over-the-counter contraceptive.

It seems pretty clear that those running the agency were looking desperately for a reason - any reason - to prevent easy access to a contraceptive that is a red flag to the administration's conservative base. In doing so, they tarnished the reputation of an agency whose decisions are supposed to be based on science.

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