GLOBE EDITORIAL
Morning-after roadblockREJECTING the overwhelming opinion of its own panel of experts, an official of the Food and Drug Administration last week blocked a bid by a drug company to make its morning-after contraceptive available over the counter. This politically driven decision will almost certainly result in more unintended pregnancies and more abortions.
While advocates of reproductive choice acknowledge that morning-after pills do not provide the protection condoms do against sexually transmitted diseases, they support easier access to Plan B. Late last year, Barr's request for approval of over-the-counter sales of Plan B, which is now available by prescription, was supported 23-4 by the FDA's expert panel. Over-the-counter sales have also been backed by the FDA's own staff, by the American College of Obstetricians and Gynecologists, and other physicians' organizations. Plan B has been available in several states through pharmacists who have agreements with physicians. Normally the FDA follows the guidance of its advisory panels and staff, especially when there is a consensus. The official who disapproved over-the-counter sales, Steven Galson, acting director of the FDA's Center for Drug Evaluation, denied he made the decision for political reasons. He told Barr he disapproved the request because only 29 of the 585 women studied by the company were under age 16 -- too small a sample, in his opinion, to prove its safety with teenagers. Galson has said he was concerned that easy availability of Plan B might make young women more likely to have sex without condoms, exposing themselves and their partners to diseases. Often in cases in which research provided by a drug maker is deemed by the FDA to be inadequate, the agency tells the firm its drug is "approvable" if it takes further steps. Galson, instead, chose to call Barr's plan "not approvable," which left no doubt about his position to the Bush administration's supporters among social conservatives.
In January, 60 of the nation's leading scientists criticized the Bush administration for systematically suppressing or misrepresenting science in making decisions. The Union of Concerned Scientists issued a report detailing such politicization of science. The White House denied the charge. By its action on Plan B, the administration has given the scientists new evidence to back their accusation. © Copyright 2004 Globe Newspaper Company.
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