GAO investigator Marcia Crosse said the GAO did not look into White House involvement. The investigation "specifically did not look at interactions outside of the FDA -- with the White House or HHS," she said. "That is not part of what we agreed to review."
The GAO report also found significant discrepancies in what lower- and higher-ranking FDA officials recalled about the process.
The report said, for instance, that the leaders of some FDA science divisions and offices recalled that top officials, including Steven Galson and Deputy Commissioner for Operations Janet Woodcock, told them months before the rejection that the application would not be approved. Woodcock and Galson, then acting director of the Center for Drug Evaluation and Research, recalled that they only discussed the possibility of a rejection and what might be missing from the application. It was Galson who signed the Plan B rejection in May 2004 after the lower-ranking officials who would normally have signed off refused.
In a formal response to the report, Woodcock said the agency followed normal procedures for a controversial drug application.
The report led some lawmakers, including Rep. Louise M. Slaughter (D-N.Y.), to call for hearings. "This report is the 'smoking gun' which clearly demonstrates that the FDA based its decision on politics, and not science," she said.
But Wendy Wright, executive vice president of Concerned Women for America, said the GAO report showed that the FDA had made the correct decision. "Making Plan B over the counter would needlessly expose adolescents to risks and reduce access to health care to those in need of it," she said.
A subsequent application to make Plan B available over the counter only to women older than 17 was also indefinitely postponed by the FDA in August. At the time, then-Commissioner Lester M. Crawford said it was unclear whether the agency had the legal authority to make a drug available without prescription only to older women.
Crawford was reported earlier to have declined to speak to the GAO investigators. The GAO report said that although he did not respond before leaving his job in September, his attorney subsequently sent a written statement saying that Crawford played no role in the first Plan B review.
