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CMS Decision is an Enormous Setback for Alzheimer's Patients and a Dangerous Infringement on FDA's Scientific Autonomy

Patients will suffer because of this bureaucratic and unnecessary second-guessing of the FDA, says BIO CEO.

April 8, 2022
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Dr. Michelle McMurry-Heath, President and CEO of the Biotechnology Innovation Organization (BIO), released the following statement in response to the Centers for Medicare and Medicaid Services’ (CMS’s) National Coverage Determination (NCD) to restrict coverage for drugs used to treat patients suffering from Alzheimer’s Disease:

“The National Coverage Determination released this evening by CMS is an enormous setback for Alzheimer’s patients and an unprecedented and dangerous infringement on the FDA’s scientific autonomy and decision-making.

“With this decision, CMS is not just saying it has no confidence in Alzheimer’s drugs approved under the FDA’s Accelerated Approval pathway. It also is undermining confidence in FDA’s traditional drug approval process more broadly.

“CMS will now subject these Alzheimer’s drugs approved under the Accelerated Approval pathway to cumbersome, expensive and time-consuming new trials that will delay and limit access. Even access to products approved under the traditional process by FDA will be significantly limited for patients while they wait for a government agreement to set up CMS-approved registries, which history tells us takes years to establish.

“Patients will suffer because of this bureaucratic and unnecessary second-guessing of the FDA. CMS is chasing innovators out of this critical field and devastating future investment and research going toward treating patients with Alzheimer’s.

“As we have said from the outset, CMS does not have the scientific expertise to do this critical work. While FDA has thousands of experienced scientists and clinicians, CMS has less than 30. FDA staffers are scientifically trained at judging the benefit and risk of all kinds of therapies and have a long history of collaboration with the scientific, patient and academic communities. CMS is not equipped to make these judgments, and today’s decision is a dangerous rebuke of the FDA’s hard-earned scientific prowess.

“In the end, CMS has actually made its initial proposal far worse and expanded the damage it will cause to many more patient populations and their loved ones.”

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