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Woodcock and Galson Depositions Released

Ex-FDA Chief Yanked Authority from Senior Staff in "Morning-After Pill" Decision, Officials Testify

New York, NY— Since January 2005, former Commissioner for the Food and Drug Administration Dr. Lester Crawford repeatedly yanked decision-making powers on Plan B from all other high-level officials, according to testimony given by the FDA's Deputy Commissioner, Dr. Janet Woodcock, and the Director of the FDA’s Center for Drug Evaluation and Research, Dr. Steven Galson, on April 26 and April 27.

"Dr. Crawford’s interference in the Plan B decision is yet another major departure from the FDA’s usual process. A commissioner has never made this kind of decision alone. The more we learn about the FDA’s decision-making around Plan B, the more we know that the agency violated its own precedents in order to deny women the means to avoid unwanted pregnancies and to reduce the need for abortions," said Simon Heller, staff attorney at the Center for Reproductive Rights, and lead counsel for the plaintiffs in the case.

Center attorneys deposed Woodcock and Galson as witnesses in a lawsuit against the FDA for failing to make the emergency contraceptive Plan B available without a prescription.

"These officials have been keeping the morning-after pill from us for years," said Erin Mahoney, an individual plaintiff in the case and coordinator of the Morning-After Pill Conspiracy. "Now they have to answer to women."

According to the depositions, in January 2005, Galson planned to issue a letter approving Plan B for over-the-counter status for women 17 years and up, but that plan was mysteriously derailed by Crawford. He "told me that he was concerned about where we were heading because he knew that I was heading towards this recommendation, and he told me that he was going to make the decision on what to do with the application," testified Galson.

The FDA was scheduled in January 2005 to announce its decision on whether it would approve Plan B for over-the-counter sales for women ages 16 and older. Instead, the agency informed Plan B’s manufacturers that it would delay a decision indefinitely. From that point on, Galson and Woodcock were kept in the dark. Woodcock testified that she asked Crawford "repeatedly" about the status of the Plan B application, but "he just said it was under evaluation."

On August 26, 2005, the FDA further delayed the decision, announcing a 60-day public comment period and an administrative rulemaking process with no specified deadline regarding the practical implications of approving a dual label product. According to testimony, neither Galson nor Woodcock were informed of that decision until shortly before the announcement, nor were they consulted. Woodcock also testified that Galson "speculated that there might be pressures on Dr. Crawford," possibly from "Congress, the administration, and so forth."

Lester Crawford will be questioned under oath on Wednesday, May 24.

The Center for Reproductive Rights filed suit against the FDA January 21, 2005, on behalf of the Association of Reproductive Health Professionals (ARHP), National Latina Institute for Reproductive Health, and nine individuals from a grassroots advocacy group, the Morning-After Pill Conspiracy. All of these groups strive to reduce unintended pregnancy rates, including teen pregnancies, by educating women about EC and increasing access to it. The individual women have experience taking and trying to get emergency contraception.

"I needed the ‘morning-after pill’ when my boyfriend, who is now my husband, and I had sex and the condom came off. The next morning, which was a Saturday, I braved the football game day traffic to go to the campus infirmary but it was closed," said Stephanie Seguin, a plaintiff and President of the Gainesville (Fl) Area National Organization for Women. "I had no idea where else to get it so I just crossed my fingers and hoped I didn't get pregnant."