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Morning-after, months later

November 15, 2005

EVERYBODY KNEW IT ANYWAY, but it's worthwhile to have a respected government office make it official: Anomalies surrounded the decision to refuse over-the-counter status to the morning-after pill. All of them point to top managers at the Food and Drug Administration who expressed more concern about the moral views of religious conservatives than the questions of health and science that are supposed to guide their decisions.

In a report released Monday, the Government Accountability Office probed the FDA's May 2004 decision on the pill, marketed as Plan B. It found that the ruling deviated from agency practice and was highly unusual in many respects.

Forty studies and 15,000 pages of documents, reviewed and approved by FDA staff, made Plan B's safety and effectiveness clear. Yet Dr. Steven Galson, then the acting director of the agency's Center for Drug Evaluation and Research, focused instead on whether easy availability of Plan B would make younger teens more promiscuous or more likely to have unprotected sex. In rejecting over-the-counter status, Galson overruled advisory panels and sub-directors of FDA offices. But he invited Barr Laboratories Inc. to come back with a proposal to make the pill available only to older teenagers and adults.

The drug company did that. Then, less than three months ago, the FDA delayed a decision, saying in true "Catch-22" fashion that it wasn't sure availability could be split up that way.

The Plan B ruling was the only one of 68 over-the-counter decisions made by the agency in a decade to raise age as an issue. There are no similar age-related marketing restrictions on other approved contraceptives, the GAO said, and the FDA never offered reasons why this should be an exception. Studies have found that easing availability of the drug does not make teenagers more likely to have unprotected sex.

There is a compelling medical reason to make Plan B readily available. The pill is most effective when used within 24 hours after intercourse. Restricting access only makes it less likely that women will get a chance to take it in time.

Religious conservatives consider Plan B a form of abortion, and abstinence to be the only acceptable form of contraception for teenagers. The first belief conflicts with studies that find no evidence the pill interferes with a fertilized egg. Its effectiveness lies in preventing fertilization. Further, restricting Plan B probably just leads to more abortions -- women who might have used the drug to avoid a pregnancy are forced to terminate it later. And the notion that abstinence trumps birth control conflicts with the reality of how many teens behave.

With the Bush administration happy to let this issue drag on unresolved, Congress now has justification -- if it was ever needed in the first place -- to move it forward. The FDA is supposed to be a health and science agency, not the moral arbiter for women or teenage girls.

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