That’s all? Here’s what Congress should have recommended on Aduhelm

Staff from two congressional committees spent 18 months investigating the events that led to the accelerated approval of Alzheimer’s drug Aduhelm, obtaining half a million pages of documents and conducting numerous interviews. The investigation revealed a regulatory process that was untethered to science, objectivity or precedent, and a corporation that made decisions based on a stunning disconnect between assumptions and realities.

The agency’s actions could have led to the exposure of millions of Americans to risks, including fatal brain bleeds, with little chance of benefit. The way the review was conducted led to a loss of confidence in FDA’s independence, the integrity of its reviews and the accelerated approval pathway. ...