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Tolerating False Positives: Amylyx, FDA, And The Legal Case For Broad Regulatory Flexibility

 
• By Sarah Karlin-Smith

Amidst bipartisan congressional pressure to approve ALS drugs, Billy Dunn, head of FDA’s neuroscience division, told advisory committee members that the law ‘demands’ flexibility in review of Amylyx’s AMX0035, and he came prepared with the citations.

person stretching while working on desk
Regulatory flexibility was a central theme at Amylyx’s second-chance FDA advisory panel for its ALS drug. • Source: Shutterstock

If Amylyx Pharmaceuticals, Inc.’s amyotrophic lateral sclerosis drug AMX0035 secures US Food and Drug Administration approval, it looks to be in no small part thanks to Billy Dunn, director of the Office of Neuroscience in the Office of New Drugs and his interpretation of the agency’s legal duty to exercise the broadest possible regulatory flexibility.

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