FDA nominee indicates Plan B contraceptive near approval

WASHINGTON – The nominee to become the next commissioner of the Food and Drug Administration indicated Thursday that the agency is close to approving a proposal to allow customers to buy the emergency contraceptive Plan B without a prescription.

Speaking at his Senate confirmation hearing, acting FDA Commissioner Lester Crawford did not formally announce a decision, but he left little doubt how the agency will ultimately rule.

“The science part is generally done,” Crawford told Sen. Hillary Rodham Clinton, D-N.Y., who had pressed him on the issue. “We’re just now down to what the label will look (like). This is going to be a very unusual sort of approval.”

The agency has been roiled in recent months by issues including drug safety, the speed of new drug reviews, possible conflicts of interest, and abortion, but it was the Plan B controversy that drew the most attention Thursday.

Both FDA staff and an advisory panel of outside experts have strongly endorsed the proposal to make emergency contraception more easily available – in part as a way to reduce the number of abortions – but the agency turned down the first application last year. Two months ago it failed to meet its deadline for ruling on a revised application. Conservative members of Congress have lobbied President Bush to reject the proposal, submitted by Barr Laboratories, because of concerns that it could lead to greater teen promiscuity.

Clinton and several other senators said the agency’s protracted struggle with the Plan B proposal has raised increasingly sharp questions about whether the FDA remains a science-based organization. “I am hopeful that we will reverse what appears to be a dangerous slide into political opinion rather than scientific evidence,” Clinton said.

Sen. Patty Murray, D-Wash., also questioned Crawford aggressively, asking whether a formal decision on Plan B would be announced before the Senate Committee on Health, Education, Labor and Pensions votes on his nomination, probably on April 13. Crawford said he doubted a decision would be forthcoming by then because of the application’s complexity, and Murray said that “troubles me greatly.” Crawford and several senators later agreed to meet in private to discuss aspects of the application that could not be discussed in public.

Crawford, 66, has served as acting commissioner twice in the past four years, for a total of almost two years. Trained as a veterinarian and pharmacologist, he has worked at senior levels for the FDA on four separate occasions.

While the sharpest questioning involved emergency contraception, he was also asked frequently – and sometimes skeptically – about the FDA’s plans to create a drug safety review panel. Crawford announced he would set up an enhanced safety review board after last year’s withdrawal of the arthritis drug Vioxx and later revelations of potential problems with similar COX-2 inhibitor painkillers, which led to broad criticisms that the agency had been lax on drug safety.

The structure of the new board is still being debated, and senators had conflicting advice for Crawford. Committee Chairman Michael Enzi, R-Wyo., warned Crawford against setting up a panel that would overemphasize safety concerns and underemphasize the benefits of drugs. But Sen. Barbara Mikulski, D-Md., said it was essential that the board be completely independent of the officials who approve drug applications in order to restore confidence in the agency.

Enzi also asked Crawford about a controversy over the medical abortion pill, RU-486. A citizens group that opposes abortion petitioned the agency to take the drug off the market for safety reasons, but supporters say the effort is political and that the drug is safe. Crawford said the agency is in the “final stages” of crafting a response to the petition.