Does the FDA question the Aduhelm decision?

Does the U.S. Food and Drug Administration (FDA) question the decision by the Centers for Medicaid and Medicare Services (CMS) to limit coverage of the Alzheimer’s drug Aduhelm? This is what senators asked the top FDA leadership during Tuesday’s Senate Health, Education, Labor, and Pensions (HELP) hearing on the role of FDA user fee agreements in advancing medical product regulation and innovation.

“CMS is saying that in order to cover a drug that FDA has determined as safe for marketing, more safety data needs to be generated,” said Sen. Susan Collins (R-ME), speaking critically of the Aduhelm decision.

The decision by the CMS, which was made final earlier this month restricts coverage of Biogen’s Alzheimer’s drug Aduhelm to patients in clinical trials. The decision means it will be hard for many patients to afford Biogen’s Aduhelm, the first FDA-approved drug for Alzheimer’s in 20 years, and the first-ever disease-modifying treatment for the condition.

“Do you question the FDA’s decision-making regarding Aduhelm’s accelerated approval?” Sen. Collins asked Dr. Patricia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research (CDER).

The FDA is “committed to continuing to utilize” accelerated approval, Dr. Cavazzoni responded. “We believe the data is solid and the drug is appropriately made available to patients,” but it’s “important to distinguish between FDA’s role and CMS’s role.”

“What concerns me is not the FDA’s approach; you stayed within your lane,” said Sen. Collins. “But CMS did not, because CMS commented not just on reasonableness and cost, but on safety. I fear it will discourage research and have an impact on the pipeline.”

It will “crush capital markets” for drug R&D, Ranking Member Richard Burr (R-NC) told the hearing.
“When we have innovation like that … and we do an approval at FDA, and CMS then limits the people it would be applicable to … they have just crushed the capital markets that financed the development of that drug.”