Former Head Of FDA To Be Desposed On Tuesday In "Morning-After Pill" Case As Agency Rejects Five-Year-Old Citizen’s Petition

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New York, NY—On Tuesday, June 13, 2006, attorneys from the Center for Reproductive Rights will question former U.S. Food and Drug Administration (FDA) Commissioner Dr. Mark B. McClellan in a court-ordered deposition about the FDA’s continued failure to make the emergency contraceptive Plan B available without a prescription.

The deposition comes as the FDA announced this past Friday, June 9, that it rejected the Center’s 2001 citizen’s petition requesting emergency contraceptive products be granted over-the-counter status. Five years ago, the Center filed the petition on behalf of numerous health care and reproductive rights organizations and until last week, the FDA claimed that it was still actively considering the petition.

"The FDA’s rejection of our citizen’s petition in the midst of this lawsuit simply confirms what we have believed all along. The FDA, in the thrall of the Bush administration’s anti-science agenda, has put aside its mission to promote public health in favor of depriving women of easier access to this important drug," said Simon Heller, staff attorney at the Center for Reproductive Rights and lead attorney in the case.

The McClellan testimony will be the fourth in a series taken by the Center as part of its lawsuit against the FDA. Last month, the Center deposed three other key figures associated with the agency’s refusal to allow women to buy Plan B over-the-counter—former Commissioner Dr. Lester Crawford, Deputy Commissioner Dr. Janet Woodcock, and the Director of the Center for Drug Evaluation and Research Dr. Steven Galson.

Next month, the Center will question another former FDA official, Dr. Susan Wood, the director of the Office of Women’s Health, who resigned last August in protest of the agency’s handling of Plan B.

In December 2003, an FDA Advisory Committee voted 23-4 to approve Barr Laboratories’ application to the FDA to make Plan B available over-the-counter, rather than just by prescription. The agency’s scientific staff supported approval, but in May of 2004, FDA senior management overruled them and rejected the application, citing concern about the pill’s use by teenagers under the age of 16.

Every year, three million women experience unplanned pregnancies in this country—one every 10.5 seconds—according to the non-partisan research organization The Guttmacher Institute. Experts estimate that better access to emergency contraception could prevent as many as half of these pregnancies.

"Decades of scientific research and years of international use of the "morning-after pill" among women of all ages have proven that it is safe, effective and belongs on drug store shelves," said Nancy Northup, President of the Center for Reproductive Rights. "We are now more determined than ever to use the courts to force the FDA to do its job and make Plan B available without prescription."

The lawsuit Tummino v. von Eschenbach was filed on January 21, 2005, by the Center for Reproductive Rights in the U.S. District Court for the Eastern District of New York on behalf of the Association of Reproductive Health Professionals (ARHP), National Latina Institute for Reproductive Health, and individuals from a grassroots advocacy group, the Morning-After Pill Conspiracy.