Aduhelm investigation heats up

Crushed

Sept. 2, 2021Updated 2:14 p.m. ET

Two powerful congressional committees investigating the controversial federal approval of Biogen’s Alzheimer’s drug, Aduhelm, demanded extensive information and documents from the Food and Drug Administration in a letter released on Thursday, making it clear that the committees’ leaders are troubled by unusual actions the agency took in the course of evaluating and approving the drug.1  “We are concerned by apparent anomalies in F.D.A.’s processes surrounding its review of Aduhelm,” the committee chairs said in a 13-page letter asking for a raft of documentation and answers to questions.

“F.D.A. granted accelerated approval for the drug despite concerns raised by experts — including the agency’s own staff” and members of its independent advisory committee, the letter said.   “We are also concerned by reports of unusual coordination between F.D.A. and Biogen throughout the drug’s approval process,” the committee added.

 

 

https://www.nytimes.com/2021/09/02/health/aduhelm-fda.html

jfkoc

thanks....important info!

Jeff86

Meanwhile, uptake of the drug has been slowed by Medicare deferring to next year a decision on covering the drug, the VA’s decision not to provide the drug, and insurers taking a wait-and-see approach.

 https://www.wsj.com/articles/biogens-new-alzheimers-drug-beyond-reach-for-many-patients-11630077741?page=1