The GAO has just released a long-awaited report documenting the politicized process that led the Food & Drug Administration to block over-the-counter (OTC) access to Plan B, the “morning-after pill,” in 2003.
The blockbuster finding of the report is that then-FDA Commissioner Lester Crawford (a close ally of anti-choice groups) reportedly decided to reject the Plan B application months before the FDA’s study of the drug was completed.
FDA officials, including the Director and Deputy Director of the Office of New Drugs and the Directors of the Offices of Drug Evaluation III and V, told us that they were told by high-level management that the Plan B OTC switch application would be denied months before staff had completed their reviews of the application. The Director and Deputy Director of the Office of New Drugs told us that they were told by the Acting Deputy Commissioner for Operations43 and the Acting Director of CDER, after the Plan B public meeting in December 2003, that the decision on the Plan B application would be not-approvable. They informed us that they were also told that the direction for this decision came from the Office of the Commissioner. … Both office reviews were not completed until April 2004.
Of course, times haven’t really changed. President Bush’s FDA is still putting politics over science, women’s health, and responsible abortion prevention, and Plan B still isn’t available over-the-counter.