FDA's 'unusual' decision on Plan B

The Food and Drug Administration's rejection of an application to make Plan B emergency contraception available over-the-counter was the result of an "unusual" decision-making process at the agency, the Government Accountability Office reported Monday.

"I think it proves the exact thing we were saying for a long time now, that this was a highly unusual process and they were putting politics ahead of science," said Sen. Patty Murray, D-Wash. "It goes completely counter to the mission of the FDA."

Murray was one of 47 congressional Democrats who, along with independent Sen. James Jeffords of Vermont, requested the GAO report.

The FDA public affairs office did not respond to a request for comment from Acting Commissioner Andrew von Eschenbach or Steven Galson, director of the Center for Drug Evaluation and Research (CDER), on the new report.

The GAO report identifies FDA staff by position, not name, but Galson was the CDER director who rejected Barr Laboratories' application to switch Plan B from prescription to OTC in May 2004. In doing so, Galson took the rare step of going against recommendations from FDA advisory panel members and his own staff.

The GAO, the investigative arm of Congress, cited four "unusual" aspects of the FDA's review of the initial OTC application for Plan B:

*Center directors like Galson normally do not sign approval or "non-approvable" letters. However, the FDA told the GAO that the two Galson subordinates who, in this case, would ordinarily sign such letters thought Plan B should go OTC.

*"High-level" FDA management became more involved than usual in the review of the Plan B OTC switch application. The report says Galson told the GAO that "management needed to be comfortable with review staff's final decision because of the high visibility and sensitivity" of the application.

*Some Galson subordinates told the GAO that "high-level" FDA management said months before agency scientists finished their review that the Plan B application would be rejected. But Galson told the GAO he made his decision "shortly" before signing the non-approvable letter.

*Galson's rationale for rejecting the Plan B switch, namely differences in cognitive development between younger and older adolescents, was "novel and did not follow FDA's traditional practices." FDA reviewers disagreed with Galson and noted that the agency had never before considered cognitive differences in deciding OTC switches.

In his May 2004 "non-approvable" letter to Barr Laboratories, Galson said the company had inadequate data about Plan B use by younger women.

Before the application could be approved, Galson wrote, Barr would have to take one of two steps: Demonstrate that girls 15 and under could safely use Plan B without a health-care professional's supervision or amend the application to allow for marketing of Plan B OTC only to females over 15.

Yet according to the GAO report, FDA reviewers two years earlier had actually denied a proposal by Women's Capital Corp. -- which later sold Plan B's marketing rights to Barr -- to study the use of prescription Plan B in girls as young as 12. Women's Capital Corp. had hoped to receive an additional six months of market exclusivity in exchange for conducting two pediatric studies, as permitted under the federal Food, Drug, and Cosmetic Act.

Barr submitted an amended application in July 2004. But then-commissioner Lester Crawford announced this past August that the FDA wasn't sure an age cutoff was legal or enforceable.

"This has developed into a cause celebre as it relates to Plan B," Vanderbilt University pharmacologist Alastair Wood, a member of the FDA's non-prescription drugs advisory committee, said Monday. "But the real issue, which is much more disturbing ... is that FDA decisions can be made based on political pressure."

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