Federal Judge Grants CRR Subpoenas For White House Documents, Testimony In Plan B Lawsuit

Federal Magistrate Viktor Pohorelsky on Monday ruled that the Center for Reproductive Rights can seek more than three years of White House documents related to FDA's rejection in 2004 of Barr Laboratories' application for nonprescription sales of the emergency contraceptive Plan B, the AP/Washington Post reports (AP/Washington Post, 11/9). CRR on behalf of the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health and others filed the suit, claiming FDA did not follow procedure when the agency in 2004 sent a "not approvable" letter in response to an application originally submitted by pharmaceutical company Women's Capital for nonprescription sales of Plan B. Women's Capital later was purchased by Barr. FDA in the "not approvable" letter cited inadequate data on Plan B's use among girls younger than age 16, and Barr subsequently submitted a revised application to make the drug available without a prescription only to girls and women ages 16 and older. In a July 31 letter to Barr subsidiary Duramed Research, acting FDA Commissioner Andrew von Eschenbach wrote that 18 is the "appropriate age" to allow women to buy Plan B without a prescription and asked Barr to raise the age restriction in its application from 16 to 18. Barr in August resubmitted its application and FDA approved it later that month. CRR in October during two hearings at a U.S. District Court in New York City asked federal judges to grant a subpoena of White House documents and officials in the lawsuit against FDA (Kaiser Daily Women's Health Policy Report, 10/12).

You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy 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.

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