FDA Should Learn From Ebola Epidemic, Take Action To Respond To Chikungunya, Other NTDs

Weekly Standard: The FDA Learned Nothing from Ebola
Michael J. Astrue, former commissioner of the Social Security Administration and former general counsel at the Department of Health and Human Services

“…No organization failed more miserably than the Food and Drug Administration [during West Africa’s Ebola epidemic last year]. As I pointed out in the Weekly Standard last year, the FDA refused to use its discretion under a 2007 law to provide vouchers for an accelerated review to any sponsor who successfully developed a drug for a designated ‘neglected tropical disease.’ The FDA never added Ebola — ​or any tropical disease​ — ​to the list included in the statute. … As is traditional with new epidemics, the FDA prefers to protect its institutional prerogatives rather than protect people suffering from [neglected tropical diseases like Ebola or chikungunya]; change will have to come from outside. … [HHS Secretary Sylvia] Burwell’s first step should be easy: Direct the FDA to add chikungunya to the neglected tropical diseases list. … The Senate should … raise the FDA’s inaction over chikungunya and the broader issue of its resistance to accelerated approvals with President Obama’s nominee for FDA commissioner, Dr. Robert Califf…” (11/9).