Posted by Michael Wonder on 20 Sep 2016
Behind the Sarepta drug approval was intense FDA bickering
19 September 2016 - The run-up to this week's approval of a Sarepta Therapeutics medicine to treat patients with Duchenne muscular dystrophy was marked by unusual bickering inside the FDA, where debate over a key scientific question morphed into a formal dispute, and the head of the drug review division was accused of being too intensely involved in the process for evaluating the medicine.
Stat News reports that the ultimate decision to approve the medicine fell to the FDA Commissioner, Dr. Robert Califf. In a 12-page memo last Friday, he deferred to Dr. Janet Woodcock, the controversial head of the drug review division, who pushed hard to approve the Sarepta medication but clashed with other FDA officials along the way.
