Editorial: Science falls victim to politics

Thursday, Nov. 17, 2005 | 7:06 a.m.

A federal report suggests the U.S. Food and Drug Administration's failure to approve the "morning-after" emergency contraceptive pill for over-the-counter sales was a political rather than scientific decision.

In a report released Monday, the Government Accountability Office says the acting director for the FDA's Center for Drug Evaluation and Research sidestepped the usual process by rejecting agency experts' recommendations and signing the letter that prevented the drug, Plan B, from being sold without a prescription.

The drug can be used to prevent an unintended pregnancy when contraception fails or isn't used, such as in cases of sexual assault. The FDA, the GAO says, departed from its usual over-the-counter approval process in four aspects it deemed "unusual."

Typically, all FDA directors sign the letter that rejects switching a drug from prescription to over-the-counter status. But they had refused to sign the one submitted for Plan B, the GAO says.

The review also included an "unusual" level of involvement from high-ranking FDA officials compared to other over-the-counter applications, the GAO says, and investigators found conflicting stories as to whether the decision to reject the application was made before the review was completed.

Finally, the GAO describes the rejection decision as "novel" and concluded it "did not follow FDA's traditional practices." The process was different than that used for the 67 other drugs proposed for over-the-counter switches from 1994 through 2004.

The FDA's acting director for drug evaluation and research told the GAO he blocked over-the-counter sales of Plan B because he was concerned about its "potential behavioral implications for younger adolescents." But FDA drug reviewers told the GAO that the agency does not consider behavioral implications in its recommendations.

The far-right conservatives who oppose abortion, and who have a stranglehold on the Bush administration, consider Plan B akin to abortion and fear that making it readily available will promote sexual promiscuity. But these considerations don't belong in a scientific review of a drug's safety and marketing guidelines.

The GAO's investigation suggests Plan B was subjected to the same type of wrong-headed, unscientific and politically motivated review the Bush administration has used to tell the American public that it is safe to build a nuclear waste dump in Nevada, that global warming is a myth, that our old-growth forests should be opened to commercial logging and that restrictions should be loosened on corporations that pollute our water and air.

Decisions affecting the public's health and our environment should be based on scientific reasons, rather than political ones.