At a surprise White House event yesterday, President Donald Trump touted a drug pricing agreement with Regeneron as the last in what has been characterized as a first round of most-favored nation dealmaking.

The agreement marks the president’s 17th MFN deal struck with drugmakers, covering all recipients of a series of White House letters published last summer. The 17 manufacturers represent “86% of the branded drug market,” according to the White House, which will now work to negotiate “many hundreds” of such deals with pharma and biotech companies.

On the surface, deal #17 shares public terms with most of the previous 16.

• Regeneron will “align U.S. prices of future medicines” with prices in “other developed countries.”
• State Medicaid programs will receive MFN pricing on Regeneron products.
• Praluent, a cholesterol-lowering medicine, will be available through TrumpRx at the reduced list price of $225.
• Regeneron will invest $27 billion in U.S. research, development and manufacturing through 2029.
• Regeneron will receive an exemption from tariffs and future pricing mandates for three years.

However, the most unique feature of Regeneron’s deal occurred a few hours earlier. The FDA announced that Regeneron’s Otarmeni won approval through the Commissioner’s National Priority Voucher pilot, the second new molecular entity to cross the program’s finish line. The first gene therapy from Regeneron, Otarmeni is approved to treat hearing loss for pediatric and adult patients with a form of genetic hearing loss.

While other gene therapies have carried list prices in the millions of dollars, Otarmeni will be provided free to patients in the U.S. (though ex-U.S. pricing is TBD). The access commitment was positioned as a core component of negotiations with the White House. Regeneron’s President and Chief Scientific Officer George Yancopoulos said the move reflects the company’s belief that the biopharma industry can be “a genuine force for good in the world.”

Despite the $0 price tag, the company caveats that pledge “may not necessarily reflect out-of-pocket costs for administration of this free therapy,” which remains outside of Regeneron’s purview. As hospitals, insurers and the federal government continue to reckon with paying for all aspects of gene therapy treatment, it’s worth tracking how the absence of a price will impact reimbursement for the roughly 50 children diagnosed with this condition each year.

– Andrew Wishon, Editor-in-Chief

Trump has nominated Dr. Erica Schwartz to be the next director of the CDC, selecting a mainstream public health veteran as the agency’s fourth leader in just over a year.

Schwartz, a physician with no clear ties to the anti-vaccine movement, served as deputy surgeon general during Trump’s first term and previously led disease surveillance and vaccination programs as chief medical officer of the U.S. Coast Guard. She holds degrees in medicine from Brown University, law from the University of Maryland, and a master’s in public health from the Uniformed Services University.

For many in the mainstream public health community, the announcement served as a sigh of relief tempered by reservations.

• Former Surgeon General Jerome Adams, who personally selected Schwartz as his deputy, called her a “battle-tested leader” with the “expertise, credibility and integrity to lead the CDC effectively…[i]f allowed to follow the science without political interference.”
• Dr. Georges Benjamin of the American Public Health Association noted Schwartz’s “demonstrated track record of competence.”
• Current CDC staff expressed “cautious optimism,” according to officials who spoke to NPR anonymously, hopeful that an experienced leadership team could restore order amid persistent internal infighting at the agency.

On the other hand, many in the vaccine-skeptic wing of MAHA have taken issue with the nomination.

• Aaron Siri, a vaccine injury lawyer and close ally of HHS Secretary Robert F. Kennedy Jr., criticized Schwartz for her role in writing vaccine mandates for some Coast Guard members during her time overseeing its health system. He argues that the CDC “needs a regulator over industry,” not “another cheerleader.”
• Prominent vaccine critic Toby Rogers called the pick “a slap in the face to the medical freedom base that gave Trump the presidency.”

Even among those who welcomed the pick, there are concerns that she will be limited by factors above her control.

• Dr. Amesh Adalja of Johns Hopkins said that, while Schwartz is well-qualified, any attempt to pivot away from the CDC’s positions over the past year “will all be window dressing if RFK Jr. is still in place.”
• Debra Houry, former CDC chief medical officer, echoed the point: “They aren’t really systematically changing what they are doing. They’re just publicly messaging differently.”

The backdrop makes these concerns hard to dismiss. If confirmed, Schwartz would inherit an agency where 80% of top director positions remain vacant and internal morale has been described as at “a nadir.” That context may explain how one White House official summarized the administration’s selection criteria to CNN: “We just need someone who’s not crazy.”

– Isha Vial, Senior Account Manager

• April 29 – committee markup of the FY2027 FDA budget bill, House Appropriations
• April 30 – annual Health Summit with the theme “America’s Health Advantage,” U.S. Chamber of Commerce

• “Unsurprisingly, the health systems that have become addicted to these taxpayer-subsidized profit streams warn that paring back 340B would prove disastrous for hospitals. They spend heavily to protect their corporate welfare. Once a business gets accustomed to handouts, it becomes extremely difficult to take them away. But it’s a fight worth having.” – Editorial Board, The Washington Post
• “I have patients who have been treated with this drug that are still alive today who would otherwise be dead.” – Dr. Anna Pavlick, The Wall Street Journal
• “Parents must realize that refusing vaccinations doesn’t just put your own child at risk. It puts other children at risk. I don’t know where [my daughter] picked up measles. It’s one of the most contagious viruses that exists, and it could have been from anywhere…She was eligible for the vaccine…and I gave it to her, but it was too late.” – Rebecca Archer, The New York Times 

• Secretary Kennedy faced bipartisan scrutiny in a series of seven congressional hearings, with lawmakers pressing him on agency cuts, vaccine policy and broader concerns about his stewardship of the nation’s health agencies. AP News:Takeaways from RFK Jr.’s gauntlet of congressional hearings.
• Medicare will proceed with a short-term bridge program to cover some GLP-1 drugs after a proposed pilot stalled due to insurer objections. Bloomberg: Medicare to Pay for GLP-1 Coverage After Insurer Pushback.
• Hospitals and other providers are pushing back on drugmakers’ proposed 340B rebate model, warning it could undermine the safety-net program by delaying or reducing access to discounted medicines. Healthcare Dive: Providers push back on 340B rebate model.
• Roche CEO Thomas Schinecker warned that Europe is losing ground to the U.S. and China in the race for new medicines, citing slower approvals, weaker investment and less attractive market conditions. Reuters: Europe risks falling further behind in medicine race, warns Roche CEO.
• PBM reform advocates are pressing the U.S. Department of Labor to finalize a transparency rule for employer health plans, arguing it would shed more light on how pharmacy benefit managers influence drug costs. Healthcare Dive: Stakeholders urge Labor Department to finalize PBM transparency rule.
• A pharma-backed petition is asking the FDA to change how it releases complete response letters, arguing fuller or faster disclosure of drug rejection decisions would improve transparency for investors and patients. Endpoints: Pharma-backed petition calls on FDA to reform release of drug rejection letters.
• Mark Cuban urged lawmakers to stop tiptoeing around PBM reform and instead pursue more aggressive structural changes, including potentially breaking up the industry’s biggest players. Fierce Healthcare: ‘Don’t be a wimp,’ Mark Cuban tells lawmakers hesitant to break up PBMs.
• Pharmacies in England are warning that the war in Iran is driving up the price of some medicines by as much as 30%, underscoring how conflict can quickly disrupt drug supply and affordability. The Guardian: Iran war pushing up till price of some drugs by up to 30%, pharmacies warn.
• Lawmakers in Colorado and Virginia are resisting efforts to curb their prescription drug affordability boards, suggesting states remain interested in aggressive drug-pricing oversight. STAT: Legislatures in Colorado and Virginia resist moves to constrain drug affordability boards.