In a report issued yesterday, the independent Government Accountability Office (GAO) questioned the Food and Drug Administration’s (FDA) handling of the application for over-the-counter use for emergency contraception Plan B. The GAO labeled some aspects of FDA’s handling of the application as “unusual” and questioned the involvement of high level officials in the process. The report further revealed that some FDA department heads said that they were told by high-level management officials that over-the-counter use of Plan B would not be approved months before the review of the application had been completed, reported the New York Times.
The report specifically referenced the role of Steve Galson, then-acting director of the Center for Drug Evaluation and Research, stating that “the rationale for the Acting Director’s decision was novel and did not follow FDA’s traditional practices.” Galson issued the not-approvable letter for Plan B in May 2004, when officials usually responsible for issuing the decision refused to sign it. The GAO also found that, out of the 67 proposals that FDA advisory committees recommended be approved for non-prescription sales from 1994-2004, the Plan B proposal was the only one not approved.
Dr. Susan Wood, the former director of the FDA’s Office on Women’s Health, resigned in August to protest the agency’s actions on Plan B. She said yesterday that, “This report is a sad reminder of why I felt compelled to resign – that instead of improving and advancing women’s health, the FDA leadership is ignoring its process and not relying on science and medical evidence.”