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Buckle up: It’s time for the FDA to face another major political test

Let’s not fool ourselves. It’s been a politically tumultuous two years for the FDA – which is supposed to review drugs and devices independent of political pressure. And surprise surprise, the FDA is about to face its next big test.


An expert panel will debate next week whether to approve a new drug to treat ALS. But, as I write in a new story for STAT, this panel is shaping up to be about much more than just a new drug.

The meeting is the culmination of months of political pressure from ALS organizations, which used petition drives, impassioned patient pleas, and even pointed questions from federal lawmakers to successfully push the agency to back off an earlier decision that would have delayed the drug’s potential approval by 2-3 years.


Now, advocates are so confident that the FDA will approve the drug, which is developed by Amylyx Pharmaceuticals, that they’re not even planning for the opposite scenario.

You can check my new story laying out the political stakes for the FDA here. And if you’re curious about the science behind the drug, my colleague Adam Feuerstein has you covered here.

Need another reason to watch the hearing? The expert panel debating the drug just so happens to be the same group of experts who were tasked with debating Biogen’s Alzheimer’s drug Aduhelm. It’ll be the group’s first time meeting since three experts resigned in protest after that approval.

The next big target for ALS advocates’ ire

The FDA isn’t the only group feeling the pressure from ALS advocates. Now the biggest ALS advocacy organization, the ALS Association, is going after one of the drug industry’s biggest foes: ICER, the drug pricing watchdog group.

ICER announced in February that it would review the cost effectiveness of Amylyx’s drug, much to the chagrin of ALS advocates. In response, the ALS Association launched a petition this month urging insurers to “prohibit” the use of the metrics ICER commonly uses to determine the value of a drug. The group calls those metrics, which are known as Quality Adjusted Life Years (QALY) and Equal Value of Life Years Gained (evLYG), arbitrary and discriminatory. The petition also calls for insurers to “provide immediate, full coverage and affordable access to new therapies for all people living with ALS.”

“Right now our biggest challenge is to make sure that this ICER review doesn’t result in a lot of administrative barriers or hassles for this drug,” said Neil Thakur, the chief mission officer of the ALS Association. “We are concerned that an ICER report will be used as justification to make a drug like Amylyx less accessible to people who will benefit from it.”

Before Aduhelm, Billy Dunn was a superstar at the FDA

Billy Dunn, the regulator at the center of the FDA’s decision to greenlight the controversial Alzheimer’s drug Aduhelm, was a shining star at the FDA before the Aduhelm saga, according to new records obtained by STAT.

STAT obtained Dunn’s personnel file as part of a Freedom of Information Act request. What stood out to us – besides his grades in undergraduate biochemistry and “basic musical skills” – was the glowing performance reviews he got from his superiors at the FDA.

In 2006, shortly after being recruited to the agency, Eric Bastings, Dunn’s supervisor, declared him “one of the very best new reviewers I have worked with.” Dunn’s superiors praised his professional judgment, ability to deftly interact with industry, and his “superb professional reputation in the neurological community” throughout the performance reviews STAT obtained.

“His performance is simply without equal. He is one of the finest medical officers I have ever known,” his 2013 performance review states.

The records add to the mystery of why Dunn — whose close collaboration with Biogen is now being reviewed as part of multiple federal investigations — would risk his unimpeachable reputation to push for the approval of the unproven drug.

Top hospital relief funding official departs Biden administration

Danita Hunter, who took over the division of HRSA responsible for distributing more than $180 billion in pandemic relief to hospitals and health clinics in Nov. 2020, has been removed from the department’s website and directory, my colleague Rachel Cohrs reports.

Hunter’s departure comes at a pivotal point for the program, as the Biden administration has chosen to shutter an initiative that paid providers for testing, vaccinating, and treating uninsured patients related to Covid-19 because Congress refused to provide any more pandemic response funding in its latest budget bill. Hunter did not respond to a request for comment.

However, there’s quite a bit of money still sitting in the Provider Relief Fund — more than $18 billion remains unobligated, according to an accounting through March 4 prepared for Congress and obtained by STAT.

HHS’ top budget official Norris Cochran said in a rare press availability Friday that the uninsured reimbursement program had to close down despite the significant funds remaining, because it was burning through money so quickly, and officials didn’t want to accept claims the fund couldn’t pay for. “The availability of money is overstated” in the documents provided to Congress, Cochran said. It’s unclear whether lawmakers will reach a compromise to provide more Covid-19 response funding.

STAT stories you may have missed

When lawmakers debated the future of the FDA’s accelerated approval program, Aduhelm took center stage.

The biggest PBMs are handling more and more of the country’s drug price negotiations.

A decision on whether to lower Medicare premiums will come “soon” according to HHS Secretary Xavier Becerra.

Is newly minted Covid-19 coordinator Ashish Jha the leader the White House needs right now?

Should drug makers stop providing essential medications to Russia?

STAT’s Megan Molteni has exclusive new details about the role of a U.S. scientists in the CRISPR babies scandal.

Biogen finally published the results of its Aduhelm trial – in a journal edited by one of its biggest backers.