Political interference in FDA’s scientific decisions—a growing, well-hidden phenomenon—burst into the open in HHS secretary Kathleen Sebelius’ shocking decision to disallow FDA approval of the Plan B emergency contraceptive for unrestricted over-the-counter sale.
It brings to mind the previous administration’s intrusion in this matter, denounced by a federal judge as “political interference” in the form of stacking an FDA advisory committee. In that case, Lester Crawford, Bush’s commissioner, took over the approval decision from the responsible FDA career official.
Beyond the rare publicized incidents, FDA employees privately note routine intrusions by HHS appointees—reorganizing enforcement and compliance offices, restricting “necessary” travel, and curbing actions against drug companies.
When government secrecy was less than it is today, HHS didn’t meddle in FDA’s business, much less publicly overrule a scientific FDA decision. As former HHS secretary Joseph A. Califano reportedly told two FDA commissioners: “I don’t want to know what you are doing—just don’t let me get any nasty surprises in the Washington Post over breakfast!”
Now the message is: Lobby HHS if you’re unhappy with FDA’s decision.
FDA science shouldn’t be political. The FD&C Act calls “the secretary” the repository of FDA’s authority to make scientific judgments, but that doesn’t excuse overturning decades of commonsense delegation of authority from politicians to scientist-regulators.
Relocating FDA outside of HHS and giving it a Federal Reserve-like independence from politics has been suggested, and this would be a prudent solution.
From the February 01, 2012 Issue of MM+M - Medical Marketing and Media