Of all the FDA’s recent troubles — and there have been many — the handling of Plan B emergency contraception has been the hardest to defend.
To quickly review for those just joining us, nearly two years ago, an FDA advisory panel voted 23 to 4 to approve over-the-counter access to the medication. One FDA panel member called it the “safest drug that we have seen brought before us.” The scientific evidence was overwhelming and access to Plan B would curtail abortion and unwanted pregnancies. This was a no-brainer and, under normal circumstances, it’d be the end of the story.
And yet, Bush’s FDA screwed it up anyway. In August, after 28 months of work, the FDA indefinitely postponed its decision on Plan B availability, in an apparent effort to make the far-right Republican base happy. Two FDA officials quit in protest and the FDA commissioner abruptly resigned rather that cooperate with a federal investigation.
Yesterday, independent federal investigators reported — surprise, surprise — everything was not quite kosher at the FDA in handling the review process for this medication.
Senior Food and Drug Administration officials were told that the application to sell the “morning-after pill” without prescription was going to be rejected before the staff completed its scientific review and months before the decision was made public, government investigators reported yesterday.
A report by the independent Government Accountability Office also said senior FDA officials, including then-Commissioner Mark B. McClellan, were actively involved in the politically sensitive decision — one of four aspects of the agency’s actions that the investigators called “unusual.”
The GAO report, requested by Congress more than 16 months ago, said the agency did not follow its normal procedures in making the scientific assessment of the Plan B proposal and in having a top official sign off on the eventual decision after lower-ranking scientists refused.
Critics of the FDA’s handling of the issue said the report confirmed their view that the agency had allowed politics to trump science.
Given the evidence, that seems like a safe bet.
When was the last time the high-ranking FDA officials decided to reject the application for a medicine before a scientific review? As far as anyone can tell, it hasn’t happened at all in recent memory.
Also note, the evidence may have been even more damning, but key support materials weren’t available to investigators.
The letter noted that Congressional investigators had been unable to uncover the role in the Plan B decision played by the former agency commissioner, Dr. Mark B. McClellan, because agency officials told investigators that all of his e-mail messages and written correspondence on the subject had been deleted or thrown out. The Democrats charged that these acts contravened federal records laws.
Dr. McClellan also did his best to personally stunt the investigation — going so far as to refuse to respond to written questions from the GAO.
Rep. Louise M. Slaughter (D-N.Y.), who yesterday demanded hearings into this fiasco, said the GAO report is “the ‘smoking gun’ which clearly demonstrates that the FDA based its decision on politics, and not science.” If anyone on the right can the make the case that Slaughter’s wrong, I’m anxious to hear it.