Tuesday, November 26, 2024

Makary for FDA. Here’s what you need to know.

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
Nov 26, 2024 View in browser
 
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By David Lim and Lauren Gardner

With Ben Leonard

PROGRAMMING NOTE: We’ll be off for Thanksgiving this Friday but back to our normal schedule on Tuesday, Dec. 3.

Driving the Day

Steve Burrows and Marty Makary speak together on stage.

Dr. Marty Makary (right), is President-elect Donald Trump's choice for FDA commissioner. | Noam Galai/Getty Images for HBO

MAKARY’S RECORD — President-elect Donald Trump’s Friday night news dump of health care nominees included the expected naming of Dr. Marty Makary as his FDA commissioner pick.

Your Prescription Pulse scribes have taken a deep dive into the Johns Hopkins surgeon’s record and employment history. We’ll get a fuller accounting after Makary is formally nominated next year and submits ethics paperwork. But here’s an early look:

He’s a prolific author and researcher. Makary has written three books about health care — “Unaccountable,” about the lack of transparency in hospital care (and that might have inspired a TV show); “The Price We Pay,” chronicling ballooning health care costs; and, most recently, “Blind Spots,” examining instances where modern medicine has ultimately gotten the science wrong (think the addictive properties of opioids).

A member of the National Academy of Medicine, Makary has published more than 250 peer-reviewed scientific papers, according to his official biography. He’s also a former editor-in-chief of MedPage Today.

He has board memberships and other executive titles on his resume. Makary is a director on the board at Harrow, an ophthalmic pharmaceuticals company, and an adviser to Sidecar Health, an insurance provider that aims to lower customer costs by eliminating provider networks and drug formularies.

He’s also chief medical adviser to Nava, a benefits brokerage, and chief medical officer at Sesame, a cash-pay health service market that offers compounded semaglutide, Stat reported over the weekend, raising questions about how Makary will approach the GLP-1 shortage brouhaha should he be confirmed.

Sesame’s founder, David Goldhill, wrote a well-known piece in The Atlantic about his father’s death from a hospital-acquired infection that references a surgery checklist Makary helped develop to reduce errors and adverse events.

He’s received mixed reviews from former health officials and scientists. Here are a few reactions we’ve gotten since Friday night’s announcement:

“Well qualified,” texted Marc Scheineson, an FDA attorney at Alston & Bird who previously worked as associate commissioner for legislative affairs under former FDA Commissioner David Kessler. “Excellent experience conducting clinical trials (review is the core of FDA function); management experience at top health research university. Could have been way worse."

Dr. Paul Offit, a pediatrician at the Children’s Hospital of Philadelphia who serves on the FDA’s independent vaccine advisory panel, said Makary’s recent defense of Robert F. Kennedy Jr.’s vaccine views on Fox News overshadowed his “reasonable criticisms” of pandemic-era policies.

“You can’t then turn around and then in any way embrace RFK Jr.,” said Offit, who is concerned about RFK’s vaccine positions.

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Can we extend Peach’s and Blossom’s pardons to ourselves, in the sense that we won’t have to work over the Thanksgiving holiday? We can only hope.

Send tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

Drug Pricing

Boxes of the the injectable weight-loss medication Wegovy are pictured.

Medicare and state Medicaid programs could cover GLP-1s like Wegovy prescribed strictly for weight loss if a proposed rule is finalized before the end of President Joe Biden's term. | Scott Olson/Getty Images

BIG CHANGE FOR WEIGHT-LOSS DRUGS? The Biden administration today proposed to require Medicare and state Medicaid programs to cover obesity drugs, a move that would dramatically expand access to the popular treatments. This would mark the first time Medicare could cover the popular weight-loss drugs known as GLP-1s solely for weight loss.

Congress banned Medicare from covering such treatments in a 2003 law, and many state Medicaid programs and private insurers do not cover the drugs. Medicare can cover the drugs for other indications like diabetes and heart conditions.

If the proposal in the waning weeks of the Biden administration is finalized and survives expected court challenges and the Trump administration, it would be a significant win for drugmakers, who are fighting new Medicare drug price negotiations in court. It would also likely increase premiums.

With less than two months remaining in the Biden administration, there likely won’t be sufficient time to finalize the rule through the traditional process. While it’s not clear how the Trump administration will handle the proposal, the drugs’ popularity could pressure them to continue the policy.

However, Robert F. Kennedy Jr., Trump’s pick to run HHS, has been skeptical of the weight-loss drugs.

Eye on the FDA

GLP-1 PATIENT PETITIONS FDA — A mother of three from Iowa recently launched a Change.org petition echoing what compounding pharmacies, telehealth providers and some pharmacists have been telling the FDA for weeks — that brand-name weight-loss drugs remain hard to find and that the prospect of cheaper copycat products leaving the market will harm patients.

Amanda Bonello, who started taking compounded tirzepatide a month ago, said she began the effort without any prodding from those interests, telling Prescription Pulse she “wanted to put a face to the movement” that’s been dominated by corporate entities.

Bonello said her main goal is for policymakers to find a way to make the brand-name products more affordable for Americans, many of whom face barriers to access via insurance. While drug prices aren’t part of the FDA’s remit, the agency and its leaders — including Commissioner Robert Califf — have acknowledged access issues created by high drug costs.

But she also wants the FDA to see that it has an incomplete picture of how many consumers take compounded GLP-1s. Trackers started by telehealth companies offer a starting point, but trying to measure the total number of compounding customers “would be like trying to measure the ocean with a cup,” Bonello said.

In the Courts

SCOTUS WON’T HEAR TOBACCO INDUSTRY CHALLENGE — An industry challenge to FDA regulations requiring new health warnings on cigarette packaging and advertising will not be heard by the Supreme Court.

The high court denied cert on Monday to R.J. Reynolds Tobacco Company’s challenge to the warnings, leaving the U.S. Court of Appeals for the Fifth Circuit’s ruling that upheld the agency’s final rule in place.

Reynolds American spokesperson Luis Pinto declined to comment on the SCOTUS action.

“The FDA does not comment on litigation,” FDA spokesperson Jim McKinney said when asked.

The FDA indicated in September that it plans to enforce the regulations in December 2025.

“The Supreme Court’s decision clears the way for the U.S. to catch up with the rest of the world in implementing this lifesaving policy,” Dennis Henigan, vice president for legal and regulatory affairs at the Campaign for Tobacco-Free Kids, said in a statement.

Document Drawer

The FDA published final guidance outlining the transitional enforcement policy for sterilizers of class III medical devices that use ethylene oxide.

The Medical Device Innovation Consortium issued a report on the Accelerate Sustainable Capability pilot study that aimed to boost medical device manufacturers’ culture around compliance and quality systems.

WHAT WE'RE READING

A Peter Thiel ally who was considered to lead the FDA during Trump’s first term is being considered for the deputy HHS secretary post, your authors and POLITICO’s Adam Cancryn report.

Dr. Marty Makary has not minced words when talking about chemical contaminants in U.S. food, E&E News’ Ellie Borst reports.

Sanofi is the latest drugmaker plotting changes to how it administers payment for medicines in the 340B drug discount program, The Wall Street Journal’s Jared Hopkins reports.

 

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Lauren Gardner @Gardner_LM

 

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