GAO Report on EC Decision Confirms Suspicions

November 28, 2005

NOW and other women's health organizations had good reason to believe that something fishy was going on at the Food and Drug Administration (FDA) when the agency took more than a year to review an emergency contraception (Plan B) application for over-the-counter (OTC) sale, then rejected it against the advice of their own professional staff and two expert advisory panels.

A report by Congress's bipartisan Government Accountability Office (GAO), released on Nov. 14, documents that there were a number of anomalies in the Plan B review and approval process. Most remarkably, the application to sell Plan B over the counter was the only one of 67 proposed prescription-to-OTC applications over the previous ten year period that was not approved after the advisory committees recommended approval.

As had been rumored for some time, the GAO investigation was obstructed by non-cooperation from top FDA officials. Then-commissioner Lester Crawford refused to comply with GAO requests. The agency would not provide copies of correspondence to and from the commissioner's office about Plan B and said that it routinely deletes or destroys all of the commissioner's correspondence, including emails and memos. If true, these procedures would be in violation of federal records law.

Decision Made Before Review Completed - Though there are conflicting accounts, top FDA political officials may have made the decision to reject the application to allow emergency contraception to be sold over-the-counter long before the medical and scientific reviews were completed. A chronology of events shows that at a January 15, 2004 meeting, the review staff was informed that the Office of the Commissioner had recommended a "not-approvable" decision even though the in-house review process was not finished, and in fact went on for another four months. To EC advocates, this is indicative of political interference operating at the highest levels.

Scientists Overruled - The near unanimous recommendations of two FDA expert advisory panels to allow OTC sale were rejected by a key division director, Dr. Steven Galson, Acting Director of Drug Research and Evaluation (CDER), who signed the non-approvable letter. Both the rejection of the advisory panels' recommendations and the lone signing of the non-approvable letter by Galson were unusual actions. The directors of offices that reviewed the application and were responsible for signing off on the non-approvable letter for Plan B disagreed with Galson's decision, and did not add their signatures to the letter.

Age Limitation Unusual and Unnecessary - The rationale for the non-approvable decision was unusual and did not follow agency practices. In rejecting the application, acting director Galson said the agency was concerned about the possible consequences of allowing younger adolescents access to EC because of their level of cognitive development. But, as the GAO review details, there have never been age-related marketing restrictions for any prescriptions or contraceptives approved for OTC sale. No pediatric studies were requested by the agency to support applying a restriction on over-the-counter sale to women 16 and younger.

The GAO report noted that high-level management's involvement with the Plan B OTC application was unusual, but the agency disagreed with this finding as with some other GAO findings. Download the full report or read the abstract online.

New York Democratic Reps. Carolyn Maloney and Joseph Crowley, along with 46 other members of Congress, had earlier requested that the Government Accountability Office conduct this study. At the release of the report, Rep. Maloney declared, "At the FDA, politics infected what should have been a medical decision…When politics trump science, what you get is bad medicine."

Maloney is sponsoring a bill, The Plan B for Plan B Act (H.R. 4229) that would require the FDA commissioner to make a final decision on Plan B within 30 days of the enactment of that legislation, or it would be automatically approved.

More Delay Possible - In yet another delaying tactic, the newly appointed (and soon to be short-term) FDA Commissioner Lester Crawford called in late August for a public comment period on the proposed age limitation and simultaneous availability of over-the-counter and prescription-only emergency contraception for women aged 16 and under. That comment period ended on Nov. 1 with thousands of messages sent to the FDA demanding immediate approval of EC OTC with no age restrictions. NOW sent the agency a strongly worded statement to that effect, and urged activists to submit comments as well. Some cynics believe that a final decision may not be announced until after the 2006 elections, so as to not upset the noisy anti-contraceptive supporters of right-wing Republicans.

Crawford resigned from the FDA shortly after the call for public comment resulted in a firestorm of objections from Congress and the public. Crawford had been under investigation for a possibly improper personal relationship with a subordinate, a charge which the agency later said was unfounded. His resignation followed shortly after the exit of Dr. Susan Wood, director of the FDA's Office for Women's Health, who resigned in protest of the agency's handling of the Plan B application.

But the dust has not settled yet. There continue to be rumors of ongoing Congressional committee investigations of various FDA actions.

Read more about the fight over Plan B.