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

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. ...