OPINION REVIEW & OUTLOOK
The FDA’s Rigged Drug Committees
A case study in how the agency gets the advice it wants to hear.
Updated Dec. 30, 2016 7:15 p.m. ET
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Among the Republican priorities in 2017 should be dismantling a culture of bureaucratic control at the Food and Drug Administration that poisons innovation and costs lives. Here’s an idea: Update part of the approval process that was patient zero for distorting data on a drug for Duchenne muscular dystrophy.
We’ve reported on the drama over eteplirsen, which FDA approved in September and is now marketed as Exondys 51 by Sarepta Therapeutics. Midlevel bureaucrats have since disparaged the therapy in public, and some insurers are denying coverage. Much of the confusion results from an April show trial known as an advisory committee meeting. A process that is supposed to provide independent advice to the FDA instead became a venue to mislead a panel of nonexperts—and the public—about the drug’s efficacy.
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It’s been demonstrated that the FDA is a tool of Big Pharma. There’s that old revolving door between being a regulator and being regulated.
Why can’t the FDA be an optional player. Let the doctors counsel patients. It’s the patients that have to decide.
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