Biogen Alzheimer’s Drug Gets Spotlight in FDA User Fee Hearing

Biogen Inc.’s Alzheimer’s drug was a main focus for lawmakers during the year’s first hearing on renewing the user fee agreements that will help fund the Food and Drug Administration.

Members of the House Energy and Commerce Committee’s health panel expressed confusion over Medicare’s preliminary decision to limit coverage of Aduhelm to patients enrolled in clinical trials, despite getting FDA approval.

“I was shocked to find out that the CMS proposed national coverage determination severely restricts Medicare for a whole class of Alzheimer’s treatments,” Rep. Cathy McMorris Rodgers (R-Wash.), ranking member of the full committee, said Thursday.

She and ...