Both sides of the debate were quick to decry the FDA's ruling as political. "Clearly in this case corners were cut," says Family Research Council health policy analyst Moira Gaul, claiming the FDA overlooked what her group calls a lack of safety evidence. Backers of Plan B, on the other hand, were angered by the FDA's age restrictions on the drug: patients under 18 must still have a prescription to get the drug, even though the FDA's own scientific advisers never recommended such a policy. "They have been playing politics with this issue for 40 months," says Jackie Payne, director of government relations for the Planned Parenthood Federation of America, of FDA leadership. "They're continuing to play politics with teens."
Plan B is a synthetic form of progesterone, a hormone commonly used in birth-control pills, and it works by by preventing ovulation, preventing fertilization of the egg, or stopping a fertilized egg from lodging in the uterus. The FDA first approved Plan B, now owned by Delaware's Barr Pharmaceuticals Inc., for use with a prescription in 1999, but the controversy erupted in 2003. That's when FDA officials rejected the recommendation of their scientific advisers and refused to grant Plan B approval for over-the-counter use. The acting director of the Center for Drug Evaluation and Research at the time, Dr. Steven Galson, said the drug should not be sold over the counter because there was insufficient evidence to suggest that teenagers would be able to self-administer the drug safely. Critics slammed Galson and other FDA officials, and said going against the medical experts' opinion was a sign that FDA leadership had caved to conservative political pressure.
In fact, the FDA considered exactly the same studies when it approved the drug Thursday as it did when it denied the drug over-the-counter sales in 2003. The difference? When Barr resubmitted the application for over-the-counter approval, it limited its request to those patients 16 and older. (A Barr spokeswoman tells TIME it was hard to recruit many girls aged 15 and younger for the kind of studies the FDA wanted, since young teens make up such a small segment of the population needing emergency contraception.) The decision to limit over-the-counter sales to women 18 and up was a compromise reached by the FDA and announced by von Eschenbach and it's a decision that Barr still intends to challenge. "We'd like to continue to do clinical work now to address the younger patients," says spokeswoman Carol Cox. In the meantime, Cox says, Barr plans to have its brand-new single-purpose prescription and over-the-counter packaging ready to ship out by the end of 2006.
The ethical debate, however, is going nowhere fast. Pro-lifers who believe life begins at conception, consider the contraceptive tantamount to abortion, and social conservatives fear that emergency contraceptives will encourage promiscuity. (A California study published in 2005 in Obstetrics and Gynecology found no link between the availability of the morning-after pill and sexual activity.) Meanwhile, even as groups like Planned Parenthood are heralding yesterday's decision as a victory for reproductive rights, they are angered that teens still face obstacles to getting emergency contraceptives. Perhaps the one thing they all agree on is that Plan B could have been handled better.