Alliance to Peripheral and Central Nervous System Drugs Advisory Committee: Serve as True Advisors to the FDA’s Expert Review 

Alliance President & CEO Sue Peschin, MHS, delivered the following public comment at the Food & Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) Meeting on June 9:

Hi everyone. I’m Sue Peschin, and I serve as President and CEO of the Alliance for Aging Research. The Alliance receives funding from the sponsor and competitors for non-branded public policy work on Alzheimer’s disease.

In her opening remarks, Dr. Buracchio reminded everyone that Leqembi was already approved by the FDA six months ago under its Accelerated Approval Pathway. The FDA may grant Accelerated Approval for medications that treat severe, life-threatening, or rare diseases—when patients have no treatment options or have run out of existing ones. Dr. Buracchio then explained the differences between accelerated and traditional approval, most notably, that the FDA requires substantial evidence of effectiveness for both types of approvals.

It was a useful 101, but it made me wonder: Why was it needed?  

Maybe because, 14 months ago, CMS announced there wasn’t enough evidence for Medicare to cover and pay for any of the early Alzheimer’s medications.

That final decision in April 2022 was the first time CMS had declined to cover a drug for its FDA-approved-medically accepted use. It was also the first time CMS denied coverage for an entire class of drugs based on clinical trial data for a single drug—before any data on other drugs in the class were available.

The public’s trust in science and government has seen better days. Misinformation and disinformation are rampant.

In CMS’ quest to prioritize financial risk over health risk, the agency is recklessly sowing doubt about the science on Leqembi, and about FDA’s scientific and regulatory authority to determine the safety and efficacy of it. It is not CMS Administrator Brooks-LaSure’s place to challenge the FDA’s use of accelerated approval, just as it’s not the remit of Commissioner Califf to publicly opine on drug pricing. This overstepping by leaders at sister health agencies has to stop. 

Recent polling data from Lake Research Partners and Public Opinion Strategies show that voters really don’t like the exception CMS is making when it comes to covering the cost of Alzheimer’s treatments. Nearly 90% of voters polled believe Medicare should be required to cover the costs of FDA-approved drugs that slow the progression of Alzheimer’s. No other recent polling on core values—from religion to even tolerance for others—even comes close.

To the Advisory Committee, please consider how your dialogue today will help or harm the public’s trust in science and in the FDA. Please serve as true advisors to the FDA’s already impartial, rigorous, and expert review. 

And to those of you listening at the White House, we need your help to make this right for people living with early Alzheimer’s. You can’t sit this one out, because you’re in charge, and it won’t happen without you.

Thank you.