WASHINGTON, Aug. 24 — The Food and Drug Administration today approved over-the-counter sales of the “morning after” contraceptive pill to those 18 and older, resolving one of the most contentious issues in the agency’s 100-year history.
The drug, an emergency contraceptive called Plan B that is manufactured by Barr Pharmaceuticals, will be sold only in pharmacies and health clinics. Buyers will have to show proof of age. Anyone under the age of 18 will still need a prescription to buy the pills.
Nationwide over-the-counter sales will begin by the end of the year, Barr said. The prescription drug presently sells for $25 to $40. The price could change, the company said. Men may purchase Plan B.
The F.D.A.’s acting commissioner, Andrew C. von Eschenbach, wrote that he decided that 18 was the appropriate cutoff for sales because pharmacies already restrict nicotine and cold medicines sales at that age.
“This approach builds on well-established state and private-sector infrastructures to restrict certain products to consumers 18 and older,” Dr. von Eschenbach wrote in a memorandum.
Dr. von Eschenbach’s predecessor, Dr. Lester M. Crawford, said last year that science supported giving over-the-counter access of the drug to women as young as 17, but that he could not figure out how to ensure that such an age restriction was enforced.
The agency has now decided that it will depend upon Barr to enforce the rules. Barr’s chairman, Bruce L. Downey, said in an interview that the company would rely on pharmacists to abide by the restrictions. Barr will not sell the pills to convenience stores, and the company will conduct surveys to measure whether the restrictions are being followed, Mr. Downey said.
Abortion rights advocates hailed the F.D.A. decision, although many bemoaned the age restriction. “We are pleased that a common-sense, common-ground agenda for reducing unintended pregnancy and the need for abortion finally won out,” said Kirsten Moore, president of the Reproductive Health Technologies Project in Washington.
Abortion opponents threatened political retribution.
“Let there be no mistake about it, today’s decision lies at the feet of President Bush and has created a lasting rift with the Catholic faithful who compromise a large part of his support base,” said the Rev. Thomas J. Euteneuer, president of Human Life International, an anti-abortion group based in Virginia.
President Bush was asked at a news conference on Monday whether he supported Dr. von Eschenbach’s intention to approve over-the-counter sales of Plan B — a rare moment when a president addressed an application pending before the F.D.A. He replied, “I support Andy’s decision.”
The F.D.A.’s approval was widely expected and led to a flood of prepared press releases from Capitol Hill offices, advocacy and medical groups.
“This long overdue decision is a victory for women’s health and for the American people who have been waiting for years for the F.D.A. to act,” Senators Hillary Rodham Clinton of New York and Patty Murray of Washington, both Democrats, said in a joint statement. The two also held a press conference.
Senator Tom Coburn, a Republican of Oklahoma, denounced the decision. “Exposing women to the high-dose hormones in Plan B without the guidance of a physician will put them at risk,” he said.
Anti-abortion groups strongly opposed Barr’s application for over-the-counter sales, saying the medicine is an abortion pill whose widespread availability could lead to an increase in sexually transmitted diseases. Abortion rights advocates pushed equally hard to get the application approved, contending that easy access to Plan B would sharply reduce the nearly one million abortions performed each year in the United States.
Both sides are wrong, studies suggest. Couples in the United States have so much unprotected sex — half of all pregnancies are unplanned — that even if the pills were very easy for anyone to obtain, they would be unlikely to cause a major change in abortion and disease rates.
“Emergency contraceptives don’t work if, like condoms, they’re left in the drawer,” said Dr. James Trussell, director of the office of population research at Princeton University. “And studies show that even if women have the pills on hand, the drawer is where they remain.”
Still, Dr. Tina Raines, associate professor of obstetrics and gynecology at the University of California San Francisco, said that over-the-counter access to Plan B will help some women avoid getting pregnant.
“Unintended pregnancy rates have been dropping over the last decade, lots of things have contributed to that, and this will, too,” Dr. Raines said.
Plan B’s effect on the F.D.A. and its image may well overshadow its public health impact.
The F.D.A. has regulatory authority over a quarter of the American economy. Despite this huge portfolio, three different F.D.A. commissioners for three years devoted countless hours to considering whether to switch a small-selling, decades old medicine to over-the-counter status.
“I cannot recall any other issue in my 45 years of watching F.D.A. that has garnered this much attention at all levels of government,” said Peter Barton Hutt, a former general counsel for the agency who now teaches drug law at Harvard.
The director of the agency’s office of women’s health resigned last year to protest what she said was the “abortion politics” behind the delay in approving Plan B. An investigation by the Government Accountability Office concluded that top agency officials had decided to reject the initial Plan B application months before a scientific review was complete.
Sworn depositions taken by lawyers for the legal advocacy organization the Center for Reproductive Rights show that some of the agency’s staff members were convinced that no amount of scientific evidence would have persuaded the agency’s political appointees to approve the application.
Dr. John Jenkins, director of the agency’s office of new drugs, said in a deposition that his boss, Dr. Steven Galson, told him “that he felt he didn’t have a choice” but to reject the application, according to transcripts provided to The New York Times.
“And he characterized that in a sense that he wasn’t sure that he would be allowed to remain as center director if he didn’t agree with the action,” Dr. Jenkins said. Dr. Galson, director of the agency’s drug center, is Dr. Jenkins’ boss.
Dr. Florence Houn, director of the office that evaluated the Plan B application, said that she was told by Dr. Janet Woodcock, a deputy F.D.A. commissioner, that a rejection was necessary “to appease the administration’s constituents, and then later this could be approved,” according to the transcripts.”
Dr. Galson and Dr. Woodcock both said in their own depositions and public statements that scientific considerations drove their decisions. In an interview, Dr. Galson refused to address the apparent inconsistencies.
“I’m extremely happy to put this phase of the decision-making process behind me and to move on to other priorities,” Dr. Galson said.
But the issue may not go away for long.
Barr will launch a study of Plan B’s use in young adolescents in hopes of getting the agency’s age restrictions lifted, Mr. Downey said. “In my mind, if we go back and have an adequate study that includes the younger group, the basis for any age restriction goes away,” he said.
Senators Clinton and Murray placed a legislative hold on Dr. Crawford’s nomination last year as F.D.A. commissioner to pressure the agency to make a decision on Plan B. They lifted their hold after Health and Human Services Secretary Michael O. Leavitt promised a decision by Sept. 1 of last year. Dr. Crawford was confirmed, and the F.D.A. announced yet another Plan B delay.
When Dr. Crawford unexpectedly resigned weeks later, the senators said that they refused to let Dr. von Eschenbach’s nomination as commissioner to advance without a Plan B decision. Today, the senators said that they would lift their hold.
The Plan B application has seeped into popular culture. It was the subject of a passionate argument earlier this month on the popular TV talk show, “The View.”
Still, confusion about the medicine is widespread. Many women’s health clinics pass out cards explaining the difference between Plan B, a contraceptive, and RU-486, the abortion drug.
Plan B is made from a synthetic hormone found in regular oral contraceptives. There are two pills, the first of which should be taken within 72 hours of unprotected sex and the second 12 hours later. Like regular contraceptive pills, Plan B generally acts by preventing ovulation or fertilization, according to the F.D.A. Plan B may in rare circumstances prevent a fertilized egg from becoming implanted — something abortion opponents decry. But regular oral contraceptives do that, too.
RU-486, on the other hand, causes a woman to miscarry a well-established pregnancy.
