Update on Plan B and the FDA

Pressure against the Food and Drug Administration to make a long-awaited decision on whether to approve the sale of Plan B (levonorgestrel) without a prescription has been increasing lately-from the courts and the U.S. Senate.

The U.S. District Court for the Eastern District of New York has refused to dismiss a lawsuit brought by the Center for Reproductive Rights (CRR) against the FDA for its failure to approve the Barr Laboratories' contraceptive drug for over-the-counter use. As a result of this decision, the plaintiffs will be allowed to take depositions from senior agency leaders, and question them on the role that outside groups have on the agency's decision-making process, according to Drug Industry Daily Online (3/1/2006). Critics of the FDA, including the CRR, believe that the agency has succumbed to outside influences and is delaying its ruling on Plan B based on moral, not scientific grounds. Moreover, the judge in the case has noted that the FDA's delay brings to question "whether they're acting in good faith," reported Medical Marketing & Media (2/2006).

In a related story, in March, President Bush announced his nomination of acting FDA commissioner, Andrew C. von Eschenbach, to take over the job permanently. Soon after the announcement, Sens. Hillary Rodham Clinton (D-NY) and Patty Murray (D.-Wash.) put up a roadblock. According to the Washington Post (3/16/06), the senators announced that they would not allow a vote on the nomination until the FDA provides a ruling on Plan B.