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Baltimore Sun (US), January 28, 2005 FDA's Decision on Morning-After Pill Is Delayed Agency misses
deadline for ruling on OTC sale of emergency
contraceptive
WASHINGTON - The government is continuing to delay a ruling on nonprescription sales of a "morning-after pill," highlighting a bitter clash over sex and reproductive rights between the White House and medical and women's groups. Under federal guidelines, the Food and Drug Administration was supposed to reach a decision last Friday on whether to make an emergency contraceptive pill available over the counter for women 16 and older. But in a highly unusual move, according to those familiar with the agency, the FDA missed its deadline and told Barr Pharmaceuticals, manufacturer of the drug known as Plan B, only that it hoped to complete its review in the "near future." Women's groups and health professionals have condemned the delay, accusing the agency of bowing to social conservatives in the Bush administration who believe emergency contraception will lead to increased teenage promiscuity. "It's absolutely another example of ideology trumping science in the area of women's reproductive health," said Nancy Northup, president of the Center for Reproductive Rights, a nonprofit legal advocacy group. Her group is suing the FDA for its failure to act. Others, such as Planned Parenthood Federation of America, say they intend to take similar action if the agency ultimately rules against over-the-counter access. Advocates of the drug - including the American Medical Association, the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists - say research shows that Plan B is a safe and effective way to reduce the nearly 2 million unwanted pregnancies and hundreds of thousands of abortions in the country each year. But opponents, including groups such as Concerned Women for America, argue that easy access to emergency contraception will lead to more risky sexual behavior, especially among teens, and more sexually transmitted disease. "Already there's tremendous pressure on kids who don't want to be sexually active," says Wendy Wright, senior policy director for Concerned Women for America. "This would only add to it." The debate over Plan B, which was approved by the FDA in 1999 for prescription use, has been percolating since the start of the Bush presidency. In the past year, it has become a contentious political matter, underscoring the administration's embrace of an abstinence-only approach to sex education and contraception, at odds with much of the medical community. Last May, the FDA came under criticism after the acting director of the FDA's Center for Drug Evaluation and Research, Dr. Steven Galson, rejected the strong recommendation of two advisory committees and his own scientific staff that favored making Plan B fully available over the counter. The advisory panels had voted 23-4 in favor of nonprescription use and were unanimous in their opinion that the drug was safe and effective in preventing pregnancy. In overruling them, Galson said there had not been enough data presented to suggest how easy access to emergency contraception would affect the sexual behavior of girls under 16. He thus echoed 49 Republican members of Congress who had written a letter to President Bush urging him to have the FDA reject the advisory panels' recommendation. Last July, the drug maker reapplied for over-the-counter approval, amending its application to address the agency's concerns about adolescent use of Plan B. As the FDA suggested, the company's new petition required girls under 16 to have a doctor's prescription. Members of the FDA's reproductive health drugs advisory committee have been open about their disdain for the agency's decision last year and their skepticism about its motives. An internal memo by the agency's director of the Office of New Drugs, John Jenkins, raised questions about whether the agency was applying a different standard to its evaluation of Plan B, since it never before drew a distinction between different age groups in considering contraceptive hormones. Dr. Michael F. Greene, director of maternal fetal medicine at Massachusetts General Hospital, who participated in last year's debate and vote on the drug, says the agency, for the first time, appears to be giving in to political pressure: "People have criticized the FDA for a lot of things - that it's been too slow to approve new drugs, that it's been too fast, not quick enough to recognize problems - but never before has the FDA been accused of being political or having decisions manipulated by politics." Last May, Galson acknowledged that his rejection of the recommendation of his advisers was not "common or usual," but he denied that his decision had anything to do with ideology or politics. A Government Accountability Office inquiry into the decision, requested by Capitol Hill Democrats, continues. An FDA spokesman, Susan Cruzan, said she could not comment on the agency's delay in ruling on Plan B because the application is still pending. The drug, a higher dose of the hormone in daily birth control pills, is 89 percent effective in preventing pregnancy if taken up to 72 hours after unprotected sex and more effective if taken within 24 hours, according to Barr. It works primarily by preventing an egg from being released or fertilized, much like other types of contraception. Since Plan B prevents a pregnancy from starting, the drug is different from mifepristone, or RU-486, which is an abortion pill. Still, because it might also work by preventing a fertilized egg from attaching to the uterus, some religious groups that disapprove of any interference with a fertilized egg, such as the U.S. Conference of Catholic Bishops, object to it. The Bush administration has shied away from wider use of emergency contraception. In its first set of guidelines for treating rape victims, recently issued by the Justice Department, there was no mention of emergency contraception, which many women's health and medical groups consider a standard precaution against pregnancy after a sexual assault. The administration has substantially increased the budget for abstinence-only sex education programs in which contraception may be mentioned only in discussions of its flaws. << Baltimore Sun -- 1/28/05 >>
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