Aug 3, 2017

The internal FDA discord over a controversial drug approval

Janet Woodcock, a top FDA director (Jose Luis Magana / AP)

The Food and Drug Administration's controversial decision last year to approve a drug for Duchenne muscular dystrophy sparked divisions within the agency — with one former-high ranking official alleging that another top official ignored the FDA's normal scientific review, according to emails obtained by journalist Charles Seife and published at Undark.

The big email: John Jenkins, who used to be the head of the FDA's Office of New Drugs, sent a memo to former FDA Commissioner Robert Califf this past September. Jenkins alleged Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, undercut the expert team that questioned the benefits of the drug — eteplirsen, branded as Exondys 51 by Sarepta Therapeutics.

Jenkins' memo also said Woodcock was in close contact with Sarepta and the patient advocacy groups who desperately wanted the drug to get the green light, and she approved the drug before vital outcomes data was published.

Why it matters: The approval process for Exondys 51 appears to have been just as controversial behind the scenes as it was in the public eye.

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