The Government Accountability Office, a nonpartisan investigatory arm of Congress, has released its report on how FDA has handled Barr Pharmaceuticals’ application to sell Plan B over the counter.
The findings are damning. Among them:
- Well before FDA scientists had evaluated Plan B, according to GAO, four senior FDA officials were told by their superiors that Plan B would be rejected.
- Top FDA officials intervened in agency decisionmaking, overriding the recommendations of expert review panels and agency scientists, in ways that were “very, very rare.”
- The rationale given for overruling those scientists was “unprecedented.”
- All of former agency administrator Dr. Mark B. McClellan’s emails and other correspondence about Plan B were destroyed, in apparent violation of federal rules.
GAO is notoriously careful in its wording. So it wouldn’t be unreasonable at this point to read into these carefully modulated terms official confirmation of our worst suspicions: the Bush Administration’s appointees at the FDA ignored the science and ran roughshod over one the most respected and impartial federal agencies to placate its political base. Then it launched a cover up.
Are we getting close to the territory reserved for special prosecutors?
I make these strong charges without partisan rancor. The intensity of my indignation is fired by the knowledge that ready access to emergency contraception reduces both the abortion rate and the teen birth rate. Every month that passes without over-the-counter emergency contraception means more unwanted pregnancies. Unwanted pregnancies lead overwhelmingly to abortions, which—no matter how strongly you support the right to choose—are no one’s idea of a public good. To a lesser degree, they lead to births—births of babies who tend to be poorly cared for and at great risk for all manner of ills. And these unwanted pregnancies all could have been prevented with emergency contraception.
As if that tragic waste weren’t enough, there is the horrifying prospect of a thoroughly politicized FDA. Let your imagination extend this precedent from emergency contraception to all manner of other pharmaceuticals and, I suspect, you’ll share my deep concern.