The Family Research Council and other groups on Thursday filed a lawsuit against FDA for its decision in August 2006 to approve Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B, the Washington Times reports. The approval means Barr can sell Plan B without a prescription to women ages 18 and older. Girls ages 17 and younger need a prescription for Plan B, which can prevent pregnancy if taken up to 72 hours after sexual intercourse (Fagan, Washington Times, 4/13). FDA's approval of Barr's application requires the company to monitor the effectiveness of the age restriction. Barr has agreed to send "anonymous shoppers" into pharmacies to test compliance with the age restriction, to distribute with the drug a booklet about its proper use, and to exclude gas stations and convenience stores from selling the drug (Kaiser Daily Women's Health Policy Report, 12/8/06). FRC -- along with the Association of American Physicians and Surgeons, Concerned Women for America and Safe Drugs for Women -- are suing the agency and FDA Commissioner Andrew von Eschenbach over the decision, the Times reports.

Lawsuit Details, Reaction
According to the lawsuit, FDA had no authority to approve the same drug and labeling for simultaneous nonprescription sales and prescription-only distribution. The lawsuit also claims that the agency cannot treat the drug differently based on the age of the buyer because "FDA lacks the authority to enforce Plan B's age limitations." In addition, the decision to approve Barr's application was made under "improper political pressure" from Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.), according to the lawsuit (Washington Times, 4/13). Murray and Clinton last year said they would place a hold in the Senate on Von Eschenbach's confirmation as FDA commissioner until FDA made a decision on the Plan B application. The senators dropped the hold after the application was approved (Kaiser Daily Women's Health Policy Report, 8/25/06). Charmaine Yoest, vice president of external relations for FRC, said the decision to approve Barr's application is "very clearly caught up in political dynamics, and I would go so far as to say there is electoral politics involved here." Susan Wood, a research professor at George Washington University School of Public Health and Health Services and former director of FDA's Office of Women's Health, said the senators simply urged the agency to make a decision one way or the other and "didn't say what the decision should be." According to the lawsuit, FDA also produced a misleading label; failed to prove the safety of the drug for use by teenagers; and failed to take some of the steps required during the decision-making process. Chris Gacek, an attorney for FRC, said, "We don't think moving [Plan B] to over-the-counter is like moving a cold medicine," adding, "There are a lot of concerns." An FDA spokesperson in an e-mail said that the agency does not comment on pending litigation. Calls to the offices of Murray and Clinton were not immediately returned, the Times reports (Washington Times, 4/13).