Moving oversight of the 340B Drug Pricing Program from HRSA to CMS has the potential to be the most consequential drug pricing governance decision of the Trump era—but it has barely registered outside of trade press.

The administration has now proposed a shift in back-to-back annual budget requests, framing it as a streamlining move that would place 340B under an agency with existing drug pricing infrastructure. That framing undersells what is actually at stake.

CMS has demonstrated an appetite for reimbursement cuts in this space, most notably cutting Medicare reimbursement rates for drugs dispensed through 340B hospitals by 28.5% in 2018 (before the Supreme Court struck down those cuts in 2022). Putting CMS in charge of a program that hospitals have come to rely on as a financial lifeline should invite some questions.

That reliance is not incidental. Medicare reimbursement has lost roughly 7.7% in purchasing power since 2020, with cumulative IPPS updates trailing inflation by a wide margin, and MedPAC projects the aggregate FFS Medicare margin will still be around negative 10% in 2026. Medicaid faces further pressure from the state-directed payment caps in the One Big Beautiful Bill. Therefore, safety-net hospitals are utilizing 340B revenues to offset what government payers aren’t covering—and considerably more in some cases, as a recent PhRMA campaign has argued.

Such context makes the CMS question urgent. HRSA has governed 340B with a relatively light hand; its new rebate pilot, launched earlier this year, is its most assertive reform move to date. CMS would likely bring tighter audit authority—but whether the agency has the incentive to reform the program is a bigger question.

340B’s growth is fundamentally cost-shifting, not cost-saving, with the “discount” absorbed by drug manufacturers, commercial insurers, employers and other purchasers. Meanwhile hospitals keep the spread between the discounted price and what they’re reimbursed.

It would stand to reason that CMS would have little financial reason to disturb an arrangement that bolsters hospital bottom lines without touching the federal budget. Program purchases have grown from an estimated $7.5 billion in 2013 to a record $100 billion in 2025. This growth has continued in part because no single agency has had both the authority and the incentive to rein it in. CMS may finally supply the authority. Whether it also supplies the incentive remains to be seen.

– Leslie Isenegger, Head of Policy, Public Affairs and Access, RC Resolve

The FDA has permanently filled three senior leadership roles impacting prescription drugs, a meaningful step toward restoring stability after significant staff departures, leadership turnover and declining morale across the agency.

The appointments provide continuity of leadership for both CDER and CBER, the departments responsible for reviewing drugs and biologics, respectively. Acting Directors Michael Davis and Karim Mikhail are now formally taking the helm of the two important FDA centers.

Davis has previously emphasized “the importance of rebuilding public trust through transparency and the agency staff quality.” Mikhail has similarly stressed the need to boost morale and restore a sense of normalcy following leadership turnover at CBER and criticism that decisions under former director Vinay Prasad had become overly politicized.

Additionally, Jared Seehafer is the agency’s first Deputy Commissioner for Technology and Artificial Intelligence, a newly created role responsible for establishing FDA-wide priorities across technology, software and AI. Acting Commissioner Kyle Diamantas said Seehafer will help build “the infrastructure and tools our workforce needs” while ensuring the agency is prepared to both use and oversee rapidly evolving technologies.

Reporting has speculated that these appointments could signal the Trump administration does not expect the Senate confirmation of FDA Commissioner nominee Heidi Overton to move with urgency. A permanent commissioner would ordinarily be expected to play a significant role in selecting permanent center leadership.

The installation of experienced leaders across several of FDA’s most consequential functions could bring greater consistency to regulatory decision-making, support workforce rebuilding efforts and provide the steadier direction that employees, patients and regulated industries have been seeking.

– Megan Hickey, Managing Director

• Sept. 14-17 – the fiercest week in pharma, Fierce Pharma Week
• Sept. 15 – subcommittee hearing on the “drivers of unaffordability for oral chemotherapy,” House Oversight
• Sept. 15-16 – committee hearings on HHS nominations (incl. Chris Klomp as deputy secretary), Senate Finance & Senate HELP
• Sept. 16 – subcommittee hearing on “securing U.S. leadership” in biotechnology, House Science
• Sept. 16 – public meeting on PDUFA reauthorization, FDA
• Sept. 23 – D.C. transatlantic policy and innovation summit on rare diseases, Servier Pharmaceuticals

• “The political story we tell ourselves is that this is an intractable partisan standoff – that Republicans and Democrats are simply too far apart on what role the government should play in healthcare to ever agree. But what if that story is wrong?” – Steven Kull, USA Today
• “The cost of running a clinical trial in the United States climbed steeply in the past few decades. For Phase 1 trials specifically, the cost for generating the evidence needed just to open one has doubled, on average, since 2017, and for some complex therapies, the cost can reach several million dollars per patient.” – Ruxandra Teslo, The New York Times
• “The question is not whether $84,000 or $39,800 a month sounds expensive. The question is what the patient receives, how long the benefit lasts and what future costs the treatment prevents.” – Steve Brozak, Forbes

• The Trump administration is pursuing more voluntary drug pricing deals beyond the 26 already announced, CMS Administrator Mehmet Oz confirmed. Bloomberg: Trump Administration Working on More Drug Pricing Deals, Oz Says.
• Sandoz CEO Richard Saynor warned that the White House’s threatened tariffs on generic drugs would force manufacturers to either raise prices or stop supplying certain medicines. CNBC: ‘Patients pay the tariff’: Swiss pharma CEO warns of Trump’s generic drug tariff threat.
• More than 1 in 5 Medicare Part D enrollees reached the IRA’s $2,000 out-of-pocket cap in 2025, pushing 66% of program drug spending into the “catastrophic phase.” Axios: Ominous outlook for Medicare drug spending.
• Industry group Medicines Australia is pushing the government to overhaul its 30-year-old discount rates applied to new drugs, arguing the outdated formula is harming patient access. Pink Sheet: Australia’s 5% Discount Rate Is Costing Patients Access To Drugs – Industry Calls For Fix.
• After FDA approval of Revolution Medicines’ pancreatic cancer drug Rasonque, patients are encountering a coverage gap between insurance plans and the now-closed expanded access program. STAT: A breakthrough pancreatic cancer drug won approval. They still struggle to access it.
• Ninety percent of the 118 major biologic drugs facing patent expiration by 2034 have no biosimilar in development, according to an AAM report. The Wall Street Journal: Cheap Biologic Drug Alternatives Stall, Threatening U.S. Healthcare Savings.
• UK pharma investment is rebounding after a slump, with the ABPI reporting nearly £2 billion in new commitments since NICE revised its cost-effectiveness threshold. Endpoints: Pharma investment in UK picks up after last year’s lull, trade group says.
• As platforms like Kalshi let traders bet on clinical trial outcomes and FDA decisions, legal experts are urging drugmakers to stress-test insider-trading and confidentiality policies. PharmaVoice: Prediction markets are putting a price on pharma’s secrets. Here’s what companies need to know.