What happened to the toughest regulatory agency in the FDA?
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Why Billy Dunn’s support for Aduhelm is so shocking
Billy Dunn, the director of the FDA’s Office of Neuroscience, has a longstanding reputation among colleagues, industry executives and patient advocates as a conservative and discerning regulator. Then came Aduhelm, Biogen’s controversial Alzheimer’s drug.
Now Dunn has emerged as perhaps the most important FDA player in the Aduhelm saga after a STAT investigation revealed that Dunn held an off-the-book meeting with the company to get the drug approved discuss. For his part, Dunn was one of Aduhelm’s biggest supporters, even calling on a skeptical advisory board last November to approve the drug based on what he calls “home run” data. This role, former colleagues told STAT, contradicts the regulator they have come to know.
My colleagues Adam Feuerstein, Damian Garde, and I spoke to more than 20 sources with connections to Dunn to create an in-depth new profile for STAT. It offers a first detailed look at the otherwise inconspicuous regulator and tries to answer the question: What about Biogen made Billy Dunn act so differently? More here.
Warning: Senators urgently need money for the future
A bipartisan group of senators is nearing the final decision on a package to fund roads, bridges, and other infrastructure priorities, and they have turned their attention to the hospital and pharmaceutical industries to fund the bill, reports my colleague Rachel Cohrs.
The deal is still in progress, but a list of health guidelines that could be included has been circulating on K Street since the end of last week. Hospitals and drug manufacturers have both activated their lobby armies to defend their territory (and money). Here is the overview:
- Delaying Trump-era policy that would eliminate the drug rebates that pharmacy middlemen and insurers use to lower the price of certain drugs. Legislators could delay or repeal the directive even further in a separate $ 3.5 trillion party package
- Prohibition of spread pricing practices by drug middlemen (more on these two below)
- Extending Medicare Sequestration Salary Cuts for Healthcare Providers
- The HHS is forcing drug manufacturers to repay the government for wasted drugs that were sold in large packages
And a somewhat surprising piggy bank: The Provider Relief Fund, which was set up to help hospitals and doctors with Covid-related losses. It’s especially attractive because the Biden administration has kept the amount of money down for months. HHS has claimed there is $ 24 billion left, but a government watchdog reported last week that there is actually $ 43.7 billion left.
The Health Resources and Services Administration said the difference was due to a semantic discrepancy about whether the funds were “unallocated” or “not committed” and that the larger number includes donors that were returned to the government and not claimed Funds from some previous tranches of relief funds.
HHS is also slow to handle the money. The agency informed stakeholders in May that the release of the remaining funds was imminent, but it never came. Now the staff has gone quiet and ignored several hospital industry groups and lobbyists for the past few weeks when the pot of money emerged as a potential cash cow for infrastructure. Providers were unable to recoup their losses after June 2020, which includes much of the surge last summer, an increase last winter, and recent Delta-related hospital stays.
The middlemen’s view of this large-scale drug pricing policy
There are some good ones and some bad ones for middlemen on the list of guidelines above: They love the idea of overturning Trump-era policies that eliminated discounts (though they think Congress doesn’t go far enough as it just does It’s about making the policy take effect.) And while you might think they’d hate the idea of banning spread pricing, it’s more nuanced than that.
This is what PCMA CEO JC Scott told me on Monday:
Independent analysis suggests that the Medicaid program’s ban on spread pricing – the practice in which middlemen cash in on the difference between what they charge their customers for a drug and what they buy it for – could make up for it .
Scott stressed, however, that the group had no problem banning Medicaid’s practice because the government was technically the customer of the middlemen and customers could choose the terms of their PBM contracts.
“If the customer chooses not to use this particular tool, we would not have a policy-based objection,” said Scott. “That is the government’s request.”
However, PCMA is against a ban on spread pricing in the commercial market. However, Scott was skeptical that budget winks would decide that such a law would save the government money. While the Wonks decided last year that a spread pricing ban would save US $ 1.7 billion, those savings did not come from the ban itself, but from transparency regulations. These transparency provisions have already been implemented, so that this time they could probably not serve as compensation.
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Drug Manufacturers Get Ready! The FDA is investigating whether pharmaceutical representatives are telling the truth at conferences.
Aduhelm is far from the first controversy caused by the FDA’s accelerated approval path.
Drug manufacturers still lag behind the law when it comes to disclosing the results of clinical trials.
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