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Aduhelm Approval Raises Concerns About US FDA Leadership, Senate Finance Chair Suggests

 
• By Cathy Kelly

Ron Wyden points to expectations Biogen’s drug will impose a heavy cost burden on Medicare as he questions FDA’s decision to approve aducanumab. He also expresses interest in a government-sponsored technology assessment program that could help establish the value of drugs.

Sen. Ron Wyden at 10 June 2021 hearing (screenshot)
Sen. Ron Wyden, D-OR, Points To Janet Woodcock's Responsibility For Approval Based On 'Skimpy' Evidence • Source: Screenshot

The potential cost to Medicare of Biogen, Inc./Eisai Co., Ltd.’s pricey new drug for Alzheimer’s disease has prompted questions regarding the US Food and Drug Administration’s leadership and the wisdom of approving a treatment that could have widespread use but is supported by tenuous evidence of efficacy, according to Senate Finance Committee Chairman Ron Wyden, D-OR.

Aduhelm (aducanumab) was approved on 7 June under the agency’s accelerated pathway on the condition that the company will conduct...

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