FDA to decide morning-after pill’s fate soon

FDA says pills safe, few side effects
Contraceptive advocates and doctors’ groups say easier access could halve the nation’s 3 million annual unintended pregnancies. FDA’s own scientists call the pills extremely safe, used by more than 2.4 million Americans and millions more women abroad with few side effects. FDA’s independent scientific advisers overwhelmingly backed over-the-counter sales in December 2003.

But FDA rejected that move, citing concern about young teens’ use of the pills without a doctor’s guidance.

Maker Barr Laboratories reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription while younger teens continue to get a doctor’s note. When FDA missed a January deadline to decide, members of Congress refused to seat the agency’s new commissioner until he pledged a new deadline — Sept. 1.

Opponents argue that unfettered access to Plan B could increase teen sex and are pushing states to restrict prescription access, too, such as by blocking requirements that emergency rooms or pharmacies sell it.

If the drug is sold without a prescription, FDA has no way to enforce an age restriction, says Wendy Wright of the conservative Concerned Women for America. “The person who buys the drug is not necessarily the person who takes the drug,” she says. “It’s a ludicrous proposal.”

Plan B’s proponents don’t like the age restriction, either, saying teens are most in need of a second chance at avoiding pregnancy — and that there’s no evidence easier access increases teen sex or makes women of any age more careless about regular contraception.

If FDA rejects even age-staggered nonprescription sales, Planned Parenthood may sue, says president Karen Pearl.

“The FDA really ignored the scientific evidence,” Pearl says. “This is absolutely the best way of assuring that when something does go wrong, that people have that second opportunity to prevent the unintended pregnancy.”

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