Plan B okayed for non-prescription (but if you're under 18 with some guy's splooge in your vag, you'll have to ask an older chick to get you some)

1. ‘Morning After’ Pill Is Cleared for Wider Sales -- by GARDINER HARRIS

WASHINGTON — 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 agency’s 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 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 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 Barr’s 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 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.”

Indeed, Plan B’s 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 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 show that some of the agency’s science 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.”

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. Crawford’s 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 I’ve 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 Eschenbach’s 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 Eschenbach’s 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 Andy’s 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 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. 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 .

Plan B is sold only in the United States and Canada. Similar drugs are available over the counter in India, Norway, Sweden and the Netherlands, and can be bought in pharmacies without a prescription in several dozen other nations, including Australia, New Zealand and about 11 European nations, according to an online listing maintained at Princeton University.


2. Easier Access to Morning-After Pills (NY Times editorial)

After more than two years of obfuscation and procrastination, the Food and Drug Administration has finally approved nonprescription use of the morning-after contraceptive pills. Yesterday’s decision will not please advocates of unrestricted access to the pills, but it is an acceptable compromise that will at least make them readily available to women 18 and older.

The news is also a reminder of how long the administration has blocked this sensible move simply to placate religious and social conservatives who consider the pills akin to abortion or an inducement to unprotected sex.

The morning-after pill, which is actually two pills taken in sequence, is an emergency contraceptive that can head off a pregnancy if taken within 72 hours of intercourse, or preferably earlier. That makes it imperative to have quick access to the pills without waiting for a doctor’s appointment to obtain a prescription.

Under the plan announced yesterday, the pills will be held behind the counter at pharmacies and health clinics. Women who show proof that they are 18 or older will be able to buy them without a prescription. Younger girls will still need a doctor’s OK. The cutoff was set at 18 because that is the age that pharmacies and other retailers already use for other restricted products.

The fight over the morning-after pill has a long and sorry history. The F.D.A.’s professional staff and its advisory committees have long held that the pills could safely be sold over the counter. There was never any good explanation for delay beyond the Bush administration’s desire to placate its political base among social conservatives.

The change of heart seems to be due to a combination of factors, including a threat by Congressional Democrats to hold up the nomination of Andrew C. von Eschenbach as F.D.A. commissioner until a decision was made, and a lawsuit forcing the agency to reveal the machinations behind the delay. The White House may also have decided that it had milked enough political advantage from the issue and could let the F.D.A. judge the issue on its merits.

Once that occurred, the call was easy. Since virtually all the scientific evidence shows that the pills are safe, no self-respecting F.D.A. commissioner could reject over-the-counter sales without looking foolish and craven.