Former FDA Commissioner Lester Crawford on Friday did not appear for a federal court-ordered deposition in a lawsuit attempting to force the government to allow nonprescription sales of Barr Laboratories' emergency contraceptive Plan B, and his attorney said Crawford might invoke his Fifth Amendment rights if he is required to testify, the Long Island Newsday reports (Kerr, Long Island Newsday, 4/29). FDA in May 2004 issued a "not approvable" letter in response to an original application submitted by Barr to authorize nonprescription sales of Plan B -- which can prevent pregnancy if taken up to 72 hours after sexual intercourse -- citing inadequate data on its use among girls age 16 and younger. After FDA rejected Barr's first application, the company submitted a revised application to make nonprescription Plan B available only to girls and women age 17 and older. In January 2005, FDA announced a delay in its decision on the revised application, after which the Center for Reproductive Rights -- on behalf of the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health and others -- filed a lawsuit against FDA in a U.S. District Court in New York, claiming the agency did not follow procedure when it first denied the application. The lawsuit also said that by not approving nonprescription sales, the agency violated women's rights to equal protection and privacy as guaranteed by the U.S. Constitution. Crawford, FDA Deputy Operations Commissioner Janet Woodcock and Steven Galson, director of FDA's Center for Drug Evaluation and Research were scheduled to testify last week (Kaiser Daily Women's Health Policy Report, 4/25). According to CRR attorney Simon Heller, Galson and Woodcock testified that Crawford excluded them from the process of deciding on Barr's application beginning in January 2005 (Long Island Newsday, 4/29).

Crawford's Attorney's Comments
Barbara Van Gelder, Crawford's attorney, on Thursday via a telephone hearing told U.S. Magistrate Viktor Pohorelsky, who is overseeing the lawsuit, that she would instruct Crawford to invoke his Fifth Amendment rights against self-incrimination if he is forced to testify in the case, the New York Times reports. Van Gelder also told the judge that Crawford is under criminal investigation by a federal grand jury involving allegations of financial misconduct and giving incorrect statements to Congress, according to a transcript of the telephone conference. Crawford did not reply to messages from the Times seeking reaction, and FDA spokesperson Kathleen Quinn also did not comment (Harris, New York Times, 4/29).

Los Angeles Times Examines the Hold on FDA Commissioner Nomination
The Los Angeles Times on Sunday examined the "standoff" between some Senate Democrats and the Bush administration over the continued delay in a decision on Barr's Plan B application and the hold on the nomination of acting FDA Commissioner Andrew von Eschenbach to permanently head the agency (Alonso-Zaldivar, Los Angeles Times, 4/30). Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) last month said they were placing a hold on a confirmation vote for von Eschenbach in the Senate because of the delay in the Plan B application (Kaiser Daily Women's Health Policy Report, 3/21). According to the Times, many experts say the "impasse" over the "unresolved question of what role religion and ideology should play in making science policy" could "continue for the rest of [President] Bush's term" (Los Angeles Times, 4/30).