How Plan B Was Delayed

| Tue Nov. 15, 2005 1:46 PM EST

A recent GAO report on the Food and Drug Administration's rejection of Plan B, an over-the-counter morning-after-pill, in 2004 tells the story of how the agency allowed political biases to override its own scientific assessments of the drug.

Conflicting reports suggest that that the FDA might have denied approval of Plan B before scientific tests were even completed. High-ranking FDA officials, including former commissioner Mark McClellan, were involved in the review of Plan B, derailing its passage before even hearing feedback from agency scientists. Investigators found that FDA officials had already stated that approval of Plan B would be rejected months before the decision was made. The Director of the Office of New Drugs, as well as the directors of the reviewing office, refused to sign the final review of the drug application, which had wide-support within the agency.

According to the GAO report, the Acting Director on the application review

was concerned about the potential behavior implications for younger adolescents of marketing Plan B OTC because of their level of cognitive development and that it was invalid to extrapolate data from older to younger adolescents.

However, it continues,

FDA review officials noted that the agency has not considered behavioral implications due to differences in cognitive development in prior OTC switch decisions and that the agency previously has considered it scientifically appropriate to extrapolate date from older to younger adolescents.

Plan B is the only over-the-counter drug denied by the FDA between 1994 and 2004. According to Planned Parenthood experts, expanding access to the drug "could prevent up to 1.7 million unintended pregnancies a year — and 800,000 abortions."

Citing a history of delays and setbacks, Planned Parenthood President Karen Pearl said the GAO report was confirmation that the FDA has put the politics of contraception before women's health. Senators Patty Murray and Hillary Clinton concurred in a statement saying that the report—originally requested by congressional representatives incensed by the 2004 block—"has confirmed what we have always suspected, that this was a politically motivated decision that came down from the highest levels at the F.D.A."

An FDA representative said that the agency stands behind its rejection of Plan B.