The Government Accountability Office has at last released its report on the Food and Drug administration's decision to deny over-the-counter status to the emergency contraception drug "Plan B." The GAO's conclusion? That the FDA's decision-making process was "unusual."
The GAO launched its inquiry after the May 2004 decision by Steven Galson, acting director of the Center for Drug Evaluation and Research, that the application to make emergency contraception nonprescription was "not approvable." The switch in status would have made the so-called morning-after pill more accessible to women trying to prevent unintended pregnancies. Galson cited safety concerns about Plan B for women under 16, despite the fact that the "not approvable" decision ran contrary to the recommendations of the FDA's joint advisory committee and the FDA review staff.
So what happened?
The GAO reports four aspects of the decision-making process that were "unusual": "First, the directors of the offices that reviewed the application, who would normally have been responsible for signing the Plan B action letter, disagreed with the decision and did not sign the not-approvable letter for Plan B. The Director of the Office of New Drugs also disagreed and did not sign the letter. Second, FDA's high-level management was more involved in the review of Plan B than in those of other OTC switch applications. Third, there are conflicting accounts of whether the decision to not approve the application was made before the reviews were completed. Fourth, the rationale for the Acting Director's decision was novel and did not follow FDA's traditional practices. The Acting Director stated that he was concerned about the potential behavioral 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. 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 data from older to younger adolescents."
The report continues: "The Plan B decision was not typical of the other 67 proposed prescription-to-OTC switch decisions made by FDA from 1994 through 2004 [It] was the only one during this period that was not approved after the advisory committees recommended approval."
Check out the whole report here.
And while you're at it, check out NARAL's cool new timer, which counts the number of days, hours, minutes and seconds that the FDA under the Bush administration has failed to act on a petition to allow over-the-counter access to the Plan B "morning-after" pill.