I’m no expert on the FDA but my science antennas are twitching nervously about this, so I’ll post and invite discussion.
In a surprising move last week, President Obama and HHS Secretary Sebelius overrules (basically, vetoed) the FDA’s recommendation to make “Plan B” morning-after contraceptives more easily available. This was widely agreed to be purely political move: politics overruling science. If so, it sounds to me like Alice In Wonderland government: regardless of any evidence, the Red Queen gets to say what the rules are.
In the NYTimes today, Harvard government professor Daniel Carpenter reacts Free the FDA by recommending that the FDA be moved out from under elected officials:
In its first few decades, the F.D.A. collaborated with scientific societies to develop technical standards for evaluating drugs, standards that have now been emulated worldwide.
He notes that the thalidomide tragedy of the 1960s happened after the FDA refused to approve it despite huge political pressure – it got circulated anyway through a clinical trial program, with tragic results. He says after that, the FDA was increasingly given final authority. (Some don’t like it at all, but that’s off topic here.)
Then he hits the heart (IMO) of the matter:
The possibilities opened by this decision are frightening. A radical pro-business secretary could now, in principle, bypass the clinical trial system and the F.D.A. approval process and decide to approve a drug. A different secretary, one distrustful of the pharmaceutical industry, could stop a drug despite strong scientific support behind it.
Thoughts? Please don’t get insulting or ranty – let’s have civil informative discussion. Teach.