Harvard Prof: FDA should be independent after Plan B debacle

HHS Secretary Kathleen Sebelius' controversial decision to overrule the FDA on access to the Plan B female contraceptive has prompted a new call for the FDA to become an independent agency--taking some of the politics out of key decisions on drugs and giving the agency the same kind of status as the Fed. Daniel Carpenter, a Harvard economics professor, made the rally call for an independent FDA in his New York Times op-ed published Tuesday.

Carpenter--who previously penned the book "Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA"--painted an ugly picture of the potential repercussions of Sebelius' move to block girls younger than 17 from buying the contraceptive Plan B (a.k.a. the morning after pill) over the counter without a prescription. With the Executive Branch of the U.S. government overruling the FDA like Sebelius did, drugmakers who don't like the FDA's decisions on their products could lobby the White House to intervene on their behalf.

The move could also embolden a future HHS secretary, perhaps one sympathetic to business causes, to act on drugmakers' behalf. And undermining FDA decisions could weaken the perception in other countries that the agency's stamp certifies the worthiness of a drug. That could hurt U.S. companies' exports.

At an independent FDA, the President wouldn't have the authority to second-guess the agency's ruling on a drug--just like he can't overrule the Fed's decisions about interest rates, Carpenter wrote. If companies don't like the FDA's decisions, they could take the agency to court. The commissioner of the agency would be given a 6-year term and could only be fired for cause.

Carpenter has joined a chorus of critics that are outraged by Sebelius's move, and never before has an HHS secretary overruled the FDA in this fashion. A group of miffed U.S. Senators has already taken Sebelius to task, asking for her rationale in making the decision about Plan B, Pharmalot's Ed Silverman reported in a piece that offers speculation that the Obama administration might have been pandering to conservatives.

- check out the NYT's op-ed
- see Pharmalot's coverage

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