U.S. FDA nominee faces senators after Plan B move

The acting Food and Drug Administration chief meets U.S. senators on Tuesday armed with a new plan for wider sales of an emergency contraceptive drug in an effort to move his stalled confirmation forward.

Two Democratic senators have pledged to block a vote on Dr. Andrew von Eschenbach until the FDA makes a final decision on allowing nonprescription sales of Barr Pharmaceuticals Inc.‘s Plan B, which can prevent pregnancy if taken within 72 hours of sexual intercourse.

Under a plan announced on Monday, the set of two pills would be kept behind pharmacy counters and available for adult women who ask for it, while those younger than 18 would still need a prescription.

FDA officials said they hoped to resolve the matter within weeks and asked to meet with the drug’s manufacturer.

Sens. Hillary Clinton of New York and Patty Murray of Washington said the FDA’s move was not enough to lift their pledge to block von Eschenbach’s nomination, especially after similar assurances were made last year.

Last year, the pair dropped their objections to a vote on the FDA’s previous nominee, Lester Crawford, after Bush officials assured them the agency would act.

Afterward, the FDA indefinitely postponed its decision on the drug, already sold as a prescription.

“The FDA’s announcement today really is once again a nondecision. We find ourselves at the same place we did a year ago,” Murray said. “Fool me once - we’re not going to go there again.”

Bush could give von Eschenbach a recess appointment while the Senate is in recess but has not threatened to do so.

Other Plan B supporters, including several women’s groups, questioned the timing of the FDA’s move. “While we hope the FDA has finally decided to stop playing politics with Plan B, we remain skeptical,” said Center for Reproductive Rights President Nancy Northup, whose group has sued the agency over the Plan B issue.

Health and Human Services Secretary Mike Leavitt said the FDA plan was a good faith effort to resolve the issue and move the nomination forward.

Barr’s bid to sell Plan B without a prescription has lingered at the FDA since 2003, spurring intense lobbying from both sides of the issue.

Supporters maintain easier access would help prevent abortions while opponents, mostly conservatives, argue it would spur promiscuity.

“An 18-year-old man, a 19-year-old woman could buy it, then turn around right in the store and give it to a 13 year-old girl. The person who buys it means nothing,” said Concerned Women for America President Wendy Wright.

Sen. Mike Enzi, chairman of the Senate Health, Education, Labor and Pensions Committee holding the hearing, said Tuesday’s meeting offered senators a chance to ask questions. The committee is not expected to vote on the nomination.

“My objective is to ensure that the FDA gets a highly-qualified, Senate-confirmed commissioner who will advance public health and safety based upon sound science, free from political pressures,” said Enzi, a Wyoming Republican.

Despite the FDA’s announcement, nonprescription sales are not certain. If the company’s plan is not “sufficiently rigorous” to keep younger girls from buying the drug without a doctor’s order, “Plan B will remain (prescription)-only for women of all ages,” von Eschenbach said in a letter to Barr.

Provided by ArmMed Media
Revision date: July 4, 2011
Last revised: by Janet A. Staessen, MD, PhD