FDA hints at shifting stance on Plan B

WASHINGTON — The Food and Drug Administration said yesterday it was ready to engage in discussions with the maker of the "morning-after pill," sold as Plan B, that could lead to over-the-counter sales of the emergency contraceptive to women 18 and over.

The shift in stance, conveyed in a letter sent Monday to a subsidiary of Barr Laboratories of Pomona, N.Y., stopped far short of a promise that the agency is ready to allow nonprescription sales of Plan B, which can prevent conception if taken within 72 hours after unprotected sex.

But by reversing an earlier suggestion that it might lack the legal foundation for an approval, the FDA raised hopes among the drug's proponents that the agency's unusually glacial review of Plan B might soon accelerate.

The letter from acting FDA Commissioner Andrew von Eschenbach to Duramed Research of Bala Cynwyd, Pa., came just one day before von Eschenbach's Senate confirmation hearing, scheduled for this morning. The timing led many of the drug's supporters, including several members of Congress, to discount the agency's announcement as a political ploy timed to defuse what was widely anticipated to be a difficult interrogation.

The timing "is not a coincidence," said Sen. Hillary Rodham Clinton, D-N.Y., who with Sen. Patty Murray, D-Wash., has promised to block a vote on von Eschenbach's confirmation until the FDA makes a decision on Plan B.

"I think they are slow-walking this," Clinton told reporters in a hastily arranged conference call, referring to the White House and conservative social and religious groups that oppose nonprescription sales of the emergency contraceptive. "They're trying to get their nominee through the political process."

FDA spokeswoman Susan Bro acknowledged that today's hearing had provided the impetus to invigorate the nearly three-year review. She said von Eschenbach did not want a prolonged discussion of Plan B to swamp his hopes of conveying to Congress his new vision for the agency.

"He wants to focus on what is his very ambitious agenda for this agency and get support for moving it forward," Bro said, adding that if upcoming talks with the manufacturer went well, approval could come within a few weeks.

Duramed spokeswoman Carol Cox said she was surprised to get the letter after about 11 months of hearing nothing from the agency. She expressed reservations about some of the restrictions the letter suggests would be necessary for approval, but said the company would be "pleased to set up a meeting as soon as possible with the FDA."

Plan B has come to symbolize what many critics of the Bush administration say is a pattern of politics trumping science.

An FDA expert-advisory committee, whose advice the agency usually accepts, recommended approval of over-the-counter sales of the contraceptive for women of any age more than two years ago. Dozens of professional societies, including the American Medical Association and the American Academy of Pediatrics, also came out in favor of nonprescription sales, saying there is no evidence backing conservatives' claims that easier access to Plan B would lead to an increase in promiscuity.

Yet the FDA has repeatedly refused to approve the switch.

That refusal has persisted even as the manufacturer offered to restrict sales to women at least 16 years old; require that the drug be sold only at pharmacies and not at convenience stores or other nonmedical outlets; and that it be kept behind a pharmacy counter so purchasers would have to ask for it and show proof of age. The company also proposed a plan to ensure that pharmacies enforced those rules.

Nine states — including Washington — allow the emergency contraceptive to be dispensed without a prescription at some pharmacies.

Murray and Clinton yesterday reiterated their intention to keep their "hold" on von Eschenbach's nomination until the FDA makes a decision on Plan B, saying they had been fooled before by the agency's intimations that it was ready to make a decision.

"Fool me once — we're not going to go there again until we get a decision on Plan B," Murray said.

Material from The Baltimore Sun is included in this report.