TIME FOR PLAN B

While it is encouraging that the federal Food and Drug Administration says it is moving closer to approving the “morning after” pill for sale without a prescription, the Senate should await final approval for the pill before voting on the new head of the agency.

The administration has been down this road before. In December 2003, an FDA panel voted 23-4 to recommend that the emergency contraception, also called “Plan B,” be sold over the counter. Six months later, the acting director of the Center for Drug Evaluation rejected this recommendation saying the drug was “not approvable” for over-the-counter sales citing concerns about the use of the drug by girls under 16.

The Plan B decision was unlike the 67 proposed prescription to over-the-counter decisions made by the FDA from 1994 through 2004, according to a Government Accountability Office review. The Plan B application was the only one that was not approved after the advisory committee recommended approval.

The FDA officials who should have been responsible for the decision disagreed with the center’s action and refused to sign the “not approvable” letter. The GAO also said the acting director’s decision was “novel” because he based the denial in part

on concerns about consequences of the drug’s marketing on younger adolescents, something the agency hadn’t considered in any of the other applications during that time.

The drug’s maker, Barr Pharmaceuticals, resubmitted its application in July 2004 with provisions to restrict sales to those over 18. Last year, Sens. Hillary Clinton and Patty Murray blocked the nomination of Lester Crawford to head the agency until the FDA issued a decision on the emergency contraceptive. After being assured the FDA would soon act on the contraceptive, the senators dropped their objections.

The FDA then indefinitely postponed a decision on Plan B, which consists of two pills that can prevent pregnancy if the first is taken within 72 hours of intercourse. The pills are not intended to end an existing pregnancy. Proponents of the drug say it will prevent unnecessary abortions while opponents worry it will promote sexual promiscuity.

Under an FDA plan announced this week, the emergency contraception would be kept behind pharmacy counters and sold to adult women who asked for it. The agency says it needs more assurances that the drug won’t be sold to those under 18, an issue it expects to resolve in a few weeks.

The renewed action on the application surprised the drug company, which reported that it had not heard from the FDA for nearly a year. The new plan was announced the day before a Senate hearing on the nomination of Andrew von Eschenbach to head the agency.

Rather than going through the same cycle again, the Senate should wait for the FDA’s approval of over-the-counter Plan B sales before voting on Mr. von Eschenbach’s nomination.