Row over Plan B unearths suspicion of political manipulation

Nov 16 2005

Congressional investigators are saying there is a suspicion that senior U.S. Food and Drug Administration (FDA) officials may have decided to reject a politically sensitive request for over-the-counter sales of a "morning-after" contraceptive months before agency scientists finished reviewing the scientific data.

In a report from the Government Accountability Office (GAO) it was found that found the FDA's May 2004 rejection of Barr Pharmaceuticals' bid for the Plan B contraceptive was "unusual," because of the involvement of high-level managers.

The investigation requested by the congressional Democrats say it provides evidence that opposition from political conservatives had swayed the FDA review.

The FDA has of course disputed the claims that the decision was made months in advance, declaring that senior officials' involvement was not out of the ordinary for complicated or controversial applications.

The GAO report says that according to officials in the FDA's Office of New Drugs, senior managers told them in December 2003, after an advisory panel supported over-the-counter sales of Plan B, that Barr's application would be rejected.

They say they were also told that the direction for this decision came from the Office of the Commissioner.

In minutes from an internal meeting on January 2004, the acting director of the FDA's Center for Drug Evaluation and Research (CDER), Steven Galson, "recommended" a rejection at that meeting, but the FDA staff reviews of Barr's data were not completed until April 2004.

According to the GAO Galson has denied that, and says he made that decision, which conflicted with the recommendations of lower-level staff, "shortly before" signing a letter to Barr dated May 6.

In comments submitted to the GAO, the FDA has said it is "inaccurate" to say a decision was made several months prior, and that the report does not reflect that the ordinary course of making regulatory decisions in CDER almost always includes discussion of alternative regulatory courses of action over a period of time.

But the GAO maintains that the Plan B review was also atypical because Galson overruled recommendations from lower staff and his rationale was "novel and did not follow FDA's traditional practices.

Plan B is a set of prescription-only pills that can prevent pregnancy if taken within 72 hours of sexual intercourse.

Barr's request to sell Plan B without a prescription has been met by intense political lobbying from supporters and opponents.

After the May 2004 rejection, Barr filed a new application asking to sell Plan B over the counter for females age 16 and older while keeping the prescription requirement for younger girls.

In August 2005, the FDA said it was indefinitely postponing a ruling on the matter.

The GAO report was requested before that announcement, and investigators did not probe that August decision.

Democratic Senators Patty Murray of Washington and Hillary Clinton of New York, say the GAO report has confirmed what they always suspected, that the decision was a politically motivated decision and came from the highest levels at the FDA.