Plan A: Approve Plan B

It's past time for the FDA to allow over-the-counter sales of emergency contraception.

FUNNY HOW a confirmation hearing can prod the Food and Drug Administration into action. Almost-action, that is. The FDA has been dithering for more than three years about whether to allow the Plan B emergency contraceptive to be sold without a prescription, as it is in 45 countries and nine states. Now it may be, finally, on the verge of permitting such sales to those 18 and older, a move that could help prevent enormous numbers of unintended pregnancies every year. Or this could be just another FDA gambit, dangling the prospect of action in hopes of getting the acting commissioner confirmed -- and overcoming the threat of Democratic senators to hold up the nomination until there is a decision. We hope it's the former.

Reason for skepticism lies in the tortured history of Plan B at the FDA. The application to make it available without a prescription was first submitted in April 2003. An FDA advisory panel overwhelmingly recommended approval in December 2003. But in May 2004 the agency overruled the panel, finding that the medication was "not approvable" for over-the-counter sales because there was not enough data on use among girls younger than 16.

That was reasonable: Although the drug -- which contains the same ingredients as birth control pills -- had been proved safe and effective, and studies showed that its availability did not lead to an increase in sexual activity, there was little hard information measuring the drug's impact on young women.

But that issue is moot in any event, because the manufacturer revised its application to limit over-the-counter sales to those 17 and older while still requiring a prescription for younger teens. At his confirmation hearing to become commissioner in March 2005, Lester M. Crawford promised that a decision was forthcoming. But when the deadline for deciding arrived that August, Mr. Crawford did not decide at all. Instead, he announced that "unique regulatory issues . . . need to be addressed" and that the agency was therefore embarking on a cumbersome rulemaking proceeding.

Mr. Crawford left the agency the following month. Now his replacement, former National Cancer Institute director Andrew C. von Eschenbach, on the eve of his own confirmation hearing this week, announced that he was junking the rulemaking and planned to talk to the manufacturer about how to make an 18-and-over restriction work. Given that retailers routinely require ID for selling alcohol and cigarettes, that should not be too difficult.

This could be good news -- or yet another feint. As Mr. von Eschenbach's letter ominously concluded, "If . . . we conclude that the . . . program isn't sufficiently rigorous" to prevent the over-the-counter product from being used by young girls, "Plan B will remain Rx-only for women of all ages."

That would be a shame. Making emergency contraception widely available could prevent up to 1.5 million unintended pregnancies and 600,000 abortions a year in the United States. Plan A for the FDA should be making Plan B available over the counter.