Plan B politics

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Plan B politics

Editorial, Boston Globe, November 20, 2005

IN MAY 2004, the Bush administration had a chance to reduce the frequency of unplanned pregnancies and abortions by letting the Food and Drug Administration approve over-the-counter sales of Plan B, an emergency contraceptive. The proposal had the full support of the FDA's staff and outside scientific advisers, but it was blocked by an administration loath to rile conservative supporters who consider contraception only slightly less deplorable than abortion.

On Monday, the Government Accountability Office reported on an investigation it did at the behest of members of Congress into the circumstances of the 2004 decision. The GAO report found there were ''unusual" practices in the rejection of the Plan B sales proposal by the FDA, including the refusal of three FDA officials to sign off on the decision -- because they disagreed with it -- and the involvement in the decision-making process of high-level FDA officials. The GAO report said there were conflicting accounts of whether agency officials had heard from higher-ups that a ''No" decision had been made on the case months before the scientific review was completed. The destruction of e-mails and written communications made it impossible to resolve all the questions surrounding the decision.

Still, the evidence in the report is strong enough to justify the accusation by members of Congress that the decision was politically motivated. Congress should now explore ways to ensure the independence of the FDA, an agency critical to the health of Americans. The report is also likely to buttress the federal-court suit filed against the FDA by the Center for Reproductive Rights. That suit calls on the agency to approve nonprescription sales of Plan B, a step that the FDA's scientific advisers found would reduce by 50 percent the 3 million unintended pregnancies each year in the United States. Plan B, which uses high-dose birth control pills, has been available since 1999 by prescription. Taken within 72 hours, it is 89 percent effective in preventing pregnancy.

The FDA based its rejection in 2004 on concern that younger adolescents might be encouraged by Plan B's over-the-counter availability to engage in unsafe safe. As the GAO report notes, that was an age-based criterion never before invoked in the approval of over-the-counter sales of other birth-control methods. Plan B's maker, Barr Pharmaceuticals, then came up with a plan to sell it over the counter to females 16 and older, but in August the FDA's commissioner postponed a decision on the proposal indefinitely, saying the FDA needed to research ways to enforce an age limit.

What the FDA really needs is enough independence from political pressure to make its decisions based on science.

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