Had unprotected sex? Condom break?
Later this year, women who fear an unwanted pregnancy can go to a pharmacy and pick up the morning-after pill without first seeing a doctor. That’s not true, however, for girls age 17 and younger, who will still need a prescription to buy the emergency contraceptive.
The drug’s manufacturer, lawmakers and women’s groups vow to try to lift that age restriction even as they applauded Thursday’s decision allowing some over-the-counter sales of the pills, called Plan B.
The Food and Drug Administration’s decision is a compromise in a three-year battle over easing restrictions on the drug, which has been available only by prescription since 1999.
"The battleground now shifts to availability for women under 18, and that is likely to prove very contentious since it is tied to strongly held beliefs about abstinence education and parental rights," said Art Caplan, director of the Center for Bioethics at the University of Pennsylvania.
The restrictions could hinder efforts to halve the nation’s annual 3 million unplanned pregnancies, supporters of unrestricted over-the-counter sales say.
“While we are glad to know the FDA finally ended its foot-dragging on this issue, Planned Parenthood is troubled by the scientifically baseless restriction imposed on teenagers,” Planned Parenthood President Cecile Richards said. “The U.S. has one of the highest rates of teen pregnancy in the Western world. Anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy.”
Studies show Plan B cuts the chances of pregnancy by 89 percent if taken within 72 hours of sex. It works best when used within 24 hours.
Barr plans studies to back non-prescription use by a broader age group, said company spokeswoman Carol Cox. The Center for Reproductive Rights said a lawsuit filed last year to do away with all age restrictions would continue.
U.S. opponents worry that greater availability of the pills will increase promiscuity and sexually transmitted diseases and promote use of the pills by sexual predators. The Family Research Council, a Christian lobbying group, said the FDA overreached and it would pursue legal and legislative options.
Conservative groups argue that plans for age enforcement are impossible.
“If the FDA thinks that enacting an age restriction will work, or that the drug company will enforce it ... then they are living in a dream world,” said Wendy Wright, president of Concerned Women for America, which led the opposition.
As a condition of approval, the drug’s manufacturer, Barr Pharmaceuticals Inc., agreed to use anonymous shoppers and other methods to check whether pharmacists are enforcing the age restriction.
FDA approval came three days after Bush said he supported the age limit on nonprescription sales.
“The FDA made clear that it will insist on stringent conditions and restrictions on access to reduce both health risks and opportunities for abuse, especially to protect minors,” White House spokeswoman Dana Perino said.
An estimated 41 countries allow emergency contraceptives to be sold without a prescription, Planned Parenthood said. It wasn’t immediately clear how many, if any, have age restrictions. Nine U.S. states already allow access by those of any age through pharmacists.
"In one sense the controversy is over," said Caplan, who also writes the Breaking Bioethics column for MSNBC.com. "With the ready availability of Plan B it would take a public health disaster to pull the drug out of pharmacies and put it back on prescription. I just don't see that happening."
For now, many proponents of the morning-after pill see the FDA's decision as a partial victory.
" I think support for making the drug more readily available to younger women without a prescription will grow as the safety of the drug becomes clear and its ability to reduce the number of abortions becomes evident," Caplan said.
Barr hasn’t said what the nonprescription pills will cost when they go on sale, perhaps as early as November. They now cost $25 to $40 in prescription form.
The pills will be sold only from behind the counter at pharmacies, not at convenience stores or gas stations. Pharmacists will check photo identification. Adult men also will be able to purchase them for their partners.
Plan B contains a concentrated dose of the same drug found in many regular birth control pills.
The FDA’s long delay in deciding on Barr’s application ensnared President Bush’s nominee to head the regulatory agency, Dr. Andrew von Eschenbach. Following the FDA’s announcement Thursday, Sens. Hillary Rodham Clinton, D-N.Y., and Patty Murray, D-Wash., said they would lift their block on the nomination, making it likely von Eschenbach will win confirmation as FDA chief, perhaps next month.
The Associated Press and Reuters contributed to this report.