FDA Expects To Make Emergency Contraception Available Without Prescription, Acting Agency Commissioner Says

Main Category: Women's Health / Gynecology
Article Date: 20 Mar 2005 - 0:00 PDT


FDA Acting Commissioner Lester Crawford on Thursday at his confirmation hearing told the... Senate Committee on Health, Education, Labor and Pensions that the agency is close to approving Barr Laboratories' application to allow the emergency contraceptive Plan B to be sold without a doctor's prescription, the Washington Post reports (Kaufman, Washington Post, 3/18). The agency in May 2004 issued a "not approvable" letter in response to Barr's original application that would have allowed Plan B to be sold without a doctor's prescription. The agency based its recommendation on a decision made by Steven Galson, acting director of the FDA Center for Drug Evaluation and Research. However, his decision contradicted the recommendations of two agency advisory panels, cited inadequate data on the use of the pills among girls ages 16 and younger. In response to the initial rejection, Barr Laboratories submitted a revised application proposing that the pills be sold without a doctor's prescription only to women ages 17 and older but be dispensed only with a doctor's prescription for girls ages 16 and younger. In January, when FDA was expected to rule on the revised application, the agency instead announced that its decision on the application would be delayed (Kaiser Daily Reproductive Health Report, 1/24).

Senate Questions Crawford
At the Senate hearing, Democratic lawmakers questioned Crawford about the delayed decision on Barr's application, the New York Times reports (Harris, New York Times, 3/18). Sen. Edward Kennedy (D-Mass.) said FDA's failure to approve Barr's original application, despite the advisory committee's recommendation for approval, could indicate that FDA is "guided by ideology instead of science" (CQ HealthBeat, 3/17). Sen. Hillary Rodham Clinton (D-N.Y.) proposed that "politics rather than science" was the reason behind the delay, according to Reuters. "It's deeply disturbing to me," Rodham Clinton said, adding, "We rely on the FDA for everything we take. I'm hopeful we will reverse what appears to be a dangerous slide into political opinion" (Richwine, Reuters, 3/17).

Crawford Response
Crawford said that FDA would issue its decision of Barr's application "within weeks," according to the Wall Street Journal (Wilde Mathews, Wall Street Journal, 3/18). He added, "The science part is generally done. We're just now down to what the label will look (like). This is going to be a very unusual sort of approval." Crawford said he "doubted" that a decision would be made before the April 13 Senate vote on his nomination for commissioner of the agency because of the "complexity" of Barr's application, according to the Post (Washington Post, 3/18). However, Crawford said, "I can assure you this decision will not be based on politics," according to Dow Jones Newswires (Corbett Dooren, Dow Jones Newswires, 3/17). He added that he could discuss details of the approval with senators "in private," according to CQ HealthBeat (CQ HealthBeat, 3/17).

"Reprinted with permission from kaisernetwork.org kaisernetwork.org. You can view the entire Kaiser Daily Reproductive Health Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/repro The Kaiser Daily Reproductive Health Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

• Additional
• References
• Citations