Wednesday, November 16, 2005

The independent and nonpartisan US congressional watchdog, the Government Accountability Office (GAO) called the Food and Drug Administration’s decision not to allow over-the-counter (OTC) sales of an Emergency Contraceptive pill, “unusual”.

Emergency Contraceptive Pills or ECPs (“morning-after” or “next-day” pills ) are used to prevent an unintended pregnancy, following unprotected sexual intercourse. They are objectionable for abortion opponents who consider their use to be a form of abortion, though scientific studies (including those by the FDA) classify them as contraceptives. The pill, called Plan B is manufactured by Barr Laboratories and had been approved earlier by the FDA as a prescription drug.

Barr Laboratories requested that the drug be approved for OTC sale for adults and prescription-only sale for minors. The decision to not approve went against the advice given by the FDA’s Joint Advisory Committee and its Review staff and led to a GAO investigation into the decision making process. The investigation was requested by 30 House members and 17 Senators.

The GAO found several anomalies in the decision making process. The rationale used by Dr. Steven Galson, the acting director of the Centre for Drug Evaluation and Research for rejecting the application was novel and did not follow usual FDA practices. The decision was not signed off by the director of the office responsible for the application and the director of the Office of New Drugs, as they disagreed with the “reject” decision. The GAO also found that the FDA’s high-level management more involved in reviewing this decision than in other change-to-OTC applications.

The Plan B decision was the only one of 67 proposed prescription to OTC changes to be disapproved, even after advisory committees approved the changes. FDA review staff told the investigators that they were told early in the review process that the decision would be made by high-level management. E-mail and other documents involving the then-FDA Commissioner Mark McClellan were found to have been destroyed “routinely”.

The FDA has disagreed with the GAO’s finding that the high-level management was more involved in processing this application and that the rationale offered was novel, despite acknowledging that the adolescent cognitive ability rationale was unprecedented in FDA practice. The accounts as to whether the decision to reject was taken prior to the reviews being completed offered to the investigators were conflicting.

The acting director cited concerns about the potential behavioral implications for younger adolescents from OTC marketing of Plan-B, given their supposed lower cognitive ability, and that it was not valid to extrapolate data from older to younger audiences. However, the FDA had not considered similar “potential behavioral implications” for younger users for other OTC-switches and had previously considered it appropriate to extrapolate data from older to younger audiences.