Commentary: Free the FDA

Daniel Carpenter, a professor of government at Harvard and the author of "Reputation and Power: Organizational Image and Pharmaceutical Regulation at the F.D.A.", says the decision by Health and Human Services secretary Kathleen Sebelius to block FDA approval of selling Plan B One-Step contraceptive pills to adolescents without a prescription sets a "shocking" precedent, in a New York Times editorial.

Mr. Carpenter wrote that it marks the first time in American history where a cabinet secretary has overruled an FDA drug-approval decision. He says this precedent could place the drug-approval power in the hands of a cabinet secretary, and by extension, the White House.

"A radical pro-business secretary could now, in principle, bypass the clinical trial system and the [FDA] approval process and decide to approve a drug," he wrote. "A different secretary, one distrustful of the pharmaceutical industry, could stop a drug despite strong scientific support behind it."

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