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0616 FINAL Woodcock Q A


FDA’s Woodcock reflects on aducanumab, drug approval standards, the future of clinical trials

Acting FDA Commissioner Janet Woodcock reflects on the past and future of drug development

Acting FDA Commissioner Janet Woodcock reflects on the past and future of drug development.

Jun 16, 2021 | 10:44 PM GMT

Acting FDA Commissioner Janet Woodcock has more experience as a drug regulator than any of her predecessors — and she has arrows in her back to prove it. While her decades of experience provide fodder for critics, they also inform her decisions with a perspective that crosses therapeutic disciplines and incorporates lessons from successes and failures over decades in which science and regulation have undergone immense changes.

In a wide-ranging conversation with BioCentury, Woodcock discussed the standards FDA applies to medical product approvals, suggested that the U.S. should consider creating a mechanism for the government to direct clinical research in emergencies, and called for faster progress on creating a learning healthcare system.

As BioCentury reported Tuesday, Woodcock also addressed FDA’s most recent controversy. She defended the accelerated approval of Aduhelm aducanumab from Biogen Inc. (NASDAQ:BIIB) for Alzheimer’s disease and said details explaining the decision will be released soon.

More broadly, she said that drug approvals force regulators to draw a line on the continuum that runs from scientific and statistical certainty on one side to the need to accept uncertainty to get medicines to patients as rapidly as possible. “It shouldn't be a wavering line, but because there's judgment involved, it turns out to be.”

Woodcock noted that decisions that seem clear in retrospect —

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