Posted by Michael Wonder on 31 Dec 2016
The FDA’s rigged drug committees
30 December 2016 - A case study in how the agency gets the advice it wants to hear.
Among the Republican priorities in 2017 should be dismantling a culture of bureaucratic control at the FDA 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 non-experts—and the public—about the drug’s efficacy.
