By GARDINER HARRIS
Published: August 24, 2006
WASHINGTON, Aug. 24 The Food and Drug Administration today approved over-the-counter sales of the morning-after contraceptive pill to women 18 and older, resolving one of the most contentious issues in the agencys 100-year history.
The drug, an emergency contraceptive called Plan B that is manufactured by Barr Laboratories, will be sold only in pharmacies and health clinics. To buy it, women will have to show proof of age. Girls under the age of 18 will still need a prescription to get the drug.
Acting F.D.A. Commissioner Andrew C. von Eschenbach said in a memorandum released this morning that he had decided that 18 was the appropriate cut-off age for sales because pharmacies already restrict nicotine and cold medicines that way.
This approach builds on well-established state and private-sector infrastructures to restrict certain products to consumers 18 and older, Dr. Andrew C. von Eschenbach wrote.
Dr. von Eschenbachs 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 decided to rely on voluntary compliance with the rules, since neither federal drug regulators nor Barr plans to police the age restriction. A memorandum written by Dr. Steven Galson, director of the F.D.A.s drug center, said that Barr should send to state pharmacy boards any reports that it happens to receive of pharmacists who repeatedly sell Plan B to minors. Barr has agreed not to sell the pills at gas stations or convenience stores, to ensure better compliance with the rules.
Anti-abortion groups strongly opposed Barrs application to switch Plan B from prescription to over-the-counter status, saying that 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 1 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 passed out like lollipops, they would be unlikely to cause a major change in abortion and disease rates.
Emergency contraceptives dont work if, like condoms, theyre 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.
Indeed, Plan Bs effect on the F.D.A. and its image may well overshadow its public health impact. The agency has been considering the switch for three years, through three different commissioners.
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 agencys office of womens 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 show that some of the agencys science staff members were convinced that no amount of scientific evidence would have persuaded the agencys political appointees to approve the application.
Dr. John Jenkins, director of the agencys office of new drugs, said in a deposition that his boss, Dr. Steven Galson, told him that he felt he didnt 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 wasnt sure that he would be allowed to remain as center director if he didnt agree with the action, Dr. Jenkins said. Dr. Galson, director of the agencys 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 administrations constituents, and then later this could be approved.
Drs. Galson and Woodcock both said in their own depositions and public statements that scientific considerations drove their decisions. One memorandum that has since been made public states that Dr. Woodcock told agency employees that she feared that Plan B could take on urban legend status that would lead adolescents to form sex-based cults.
Sen. Hillary Clinton, a Democrat from New York, and Sen. Patty Murray, a Democrat from Washington State, became so concerned about the delays surrounding Plan B that they placed a legislative hold on Dr. Crawfords nomination last year as F.D.A. commissioner.
The senators lifted the hold after Health and Human Services Secretary Michael O. Leavitt promised that the F.D.A. would act on the Plan B application by Sept. 1 of last year. Dr. Crawford was confirmed.
The agency then announced a further delay in the application, something Ms. Murray said in an interview amounted to the worst double-cross Ive ever seen in my time in the Senate. Mr. Leavitt responded that the delay amounted to an action.
When Dr. Crawford unexpectedly resigned weeks later, the senators said that they would not be fooled again. They have held up Dr. von Eschenbachs nomination to become commissioner, saying that this time they want a Plan B decision first.
The agency added to this strange history today when it released several documents supporting its Plan B decision, including an extraordinary 7-page memorandum by Dr. Galson that clarifies some of his earlier statements.
The memo explains why he now agrees with Dr. von Eschenbach that 18 is a better age restriction than 17, and offers a detailed rebuttal of a previously undisclosed suggestion by subordinates that complaints about noncompliant pharmacists be sent to the federal agency instead of state pharmacy boards.
In a press briefing on Monday, President Bush was asked whether he supported Dr. von Eschenbachs intention to approve over-the-counter sales of Plan B a rare moment when a president addressed an application pending before the agecny.
Mr. Bush said that minors should need a prescription to obtain Plan B.
And I support Andys decision, he said.
The Plan B application has also seeped into popular culture. Earlier this month, Plan B was the subject of a passionate argument on the popular TV talk show, The View.
Still, confusion about the medicine is widespread. Many womens 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. It should be taken within 72 hours of unprotected sex, and like The Pill, it generally acts by preventing ovulation or fertilization, according to the agency. Plan B may in rare circumstances prevent a fertilized egg from becoming implanted something abortion opponents decry. But regular oral contraceptives would prevent implantation in the same way.
RU-486, on the other hand, causes a woman to miscarry a well-established pregnancy.