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In a disheartening case of politics trumping science, the Food and Drug Administration (FDA) recently repudiated its own expert advisory panel and rejected over-the-counter sale of the emergency contraceptive Plan B, more commonly known as the “morning after pill.” We have long supported the over-the-counter sale of Plan B, and we hope that the FDA will reconsider its unfortunate ruling.
This year, the FDA’s expert advisory panel voted 27 to 0 in favor of allowing Plan B to be sold over-the-counter. Despite the overwhelming support for widespread access to emergency contraception, however, the FDA’s handlers claim that the drug has not yet proven safe for younger teenagers. This unexpected decision came right after President Bush received a letter from 49 conservative Congress members pleading that the proposal be rejected—access to emergency contraception without a prescription would undoubtedly increase promiscuity among America’s daughters, conservatives claimed.
Under U.S. law, the FDA is required to approve drugs for sale so long as their safety and efficacy are confirmed. However, in the case of Plan B, it seems that the FDA disregarded protocol in hopes of gratifying conservative interests. In fact, two FDA officials, acting director of the FDA’s Center for Drug Evaluation and Research Steven Galson and acting FDA commissioner Lester M. Crawford are being urged to resign for playing politics at the FDA. Some congressmen are also calling for an investigation of the FDA in order to determine whether their dealings were, in fact, politically motivated.
Aside from the questionable sincerity of the FDA’s proceedings, the rejected proposal is a medical tragedy for women across the nation. Emergency contraception is a safe and effective method of reducing a woman’s risk of becoming pregnant with and effectiveness of between 75 to 99 percent. According to the Alan Guttmacher Institute, over-the-counter availability of Plan B would result in 1.7 million fewer unwanted pregnancies and 800,000 fewer abortions each year. Moreover, a recent study published in the Journal of Pediatric and Adolescent Gynecology has shown that providing sexually active teenage girls with emergency contraception in no way makes them more likely to have unprotected sex—conservative concerns about increased promiscuity were thus proved unfounded and irrelevant. But as long as Plan B is a prescription drug, access is limited—doctors are hard to get a hold of on weekends and during holidays, and biased pharmacists often refuse to sell it.
Whereas 26 other countries including Sri Lanka, Albania and Madagascar have made emergency contraception available without prescription years ago, the U.S. government continues to put politics ahead of women’s health. The FDA should take politics out of science and rescind its decision.
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