ARTICLE | Politics, Policy & Law

Aduhelm investigations could spur changes at FDA

Scrutiny of Alzheimer’s approval may lead to clampdown on biopharmas’ informal communications with agency

September 3, 2021 12:24 AM UTC

Congress is ratcheting up the pressure on FDA to disclose details about and provide justifications for its accelerated approval of Aduhelm for Alzheimer’s, setting in motion processes that could alter career paths of FDA officials in the short term and in the longer term may lead to procedural and policy changes that affect how drugs are developed and reviewed.

There is no precedent for FDA withdrawing an approval based on second-guessing its review decision, but there are examples of approval controversies leading to long-lasting changes in law and policy. ...