FDA Attorneys seek dismissal of Plan B lawsuit

Oct 16 2006

The Center for Reproductive Rights on Wednesday 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 its lawsuit against FDA over the agency's rejection of Barr Laboratories' first application for nonprescription Plan B sales, Long Island Newsday reports (Kerr, Long Island Newsday, 10/12).

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 in May 2004 the agency sent a "not approvable" letter in response to an application originally submitted by pharmaceutical company Women's Capital for nonprescription sales of Plan B. Plan B can prevent pregnancy if taken up to 72 hours after sexual intercourse. 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 (Kaiser Daily Women's Health Policy Report, 8/25).

Franklin Amanat, an assistant U.S. attorney representing FDA, on Wednesday said FDA plans to file a motion for dismissal now that the "vast majority who would purchase the drug" without a prescription may do so. However, federal Magistrate Viktor Pohorelsky, who is hearing arguments in the lawsuit, said, "I'm inclined to permit discovery [in the case] be completed," adding, "How much, I don't know." CRR is seeking subpoenas for testimony from former White House policy aide Jay Lefkowitz and FDA Deputy Director Sandra Kweder (Driver, Reuters, 10/11). CRR attorney Simon Heller said if the government has "nothing to hide, they shouldn't be fighting it" (Long Island Newsday, 10/12). Amanat said CRR has not produced evidence required to force presidential records to be released (Caruso, AP/SiLive.com, 10/11). U.S. District Judge Edward Korman during a hearing in the case earlier in the day said that the FDA's rejection and delays of Barr's application "reeks with bad faith" (Long Island Newsday, 10/12).