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.<\/p>\n
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.<\/p>\n
And yet, Bush’s FDA screwed it up anyway. In August, after 28 months of work, the FDA indefinitely postponed<\/a> 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<\/a> rather that cooperate with a federal investigation.<\/p>\n Yesterday, independent federal investigators reported — surprise, surprise — everything was not quite kosher<\/a> at the FDA in handling the review process for this medication.<\/p>\n 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.<\/p>\n 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.”<\/p>\n 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.<\/p>\n Critics of the FDA’s handling of the issue said the report confirmed their view that the agency had allowed politics to trump science.<\/p><\/blockquote>\n Given the evidence, that seems like a safe bet. Also note, the evidence may have been even more damning, but key support materials weren’t available<\/a> to investigators.<\/p>\n 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.<\/p><\/blockquote>\n 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.<\/p>\n
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\nWhen was the last time the high-ranking FDA officials decided to reject the application for a medicine before<\/i> a scientific review? As far as anyone can tell, it hasn’t happened at all in recent memory.<\/p>\n