At a Monday press event, the White House unveiled new agreements with mid-size biopharma companies that have pledged to cut prices on certain medicines in the U.S.

What first caught many eyes were the nine drugmakers involved in the announcement: Alcon (lacking a press release), Astellas, BeOne Medicines, BridgeBio, CSL, Kyowa Kirin, Sun, Teva, and UCB. Major companies speculated by Financial Times and Reuters were notably absent, and only one of the nine present drugmakers are based in the U.S. (BridgeBio).

President Trump appeared confident that any holdouts would soon sign on: “We now have 26 companies representing 90% of the domestic pharmaceutical market, and the other 10% are also coming in…They have no choice.”

Among the terms companies agreed to:

• Price reductions to MFN levels on select products in Medicaid and guaranteed MFN prices on “all new innovative medicines”
• Exemptions from MFN pricing demos in Medicare
• Investments totaling at least $19.6 billion to onshore manufacturing and R&D operations in exchange for relief from U.S. tariffs
• Four companies committed to donations for the U.S. Strategic Active Pharmaceutical Ingredients Reserve

The agreements are projected to save Americans more than $600 billion, the president said. However, analysts speculate that carve-outs for orphan drugs and the focus on Medicaid savings—where medicines are already deeply discounted—may blunt the deals’ impact on what patients pay.

Reporters note that the White House’s deal-making remains a work in progress, with Teva indicating in its announcement that some aspects of the agreement are still not finalized. On the flip side, Incyte (which was not involved in Monday’s event) disclosed in an SEC filing that it has struck an MFN agreement of some sort.

– Andrew Wishon, Editor-in-Chief

Schools are back in session. The first leaves are starting to change. There may even be a chill in the air.

Among autumn’s many harbingers is another: This week, multiple medical groups issued new vaccine guidance ahead of the fall respiratory illness season.

Six organizations issued joint recommendations for combating COVID-19, RSV and the flu. The immunization guidelines, which counter narrower federal recommendations, recommend:

• Annual flu vaccines for all people ages six months and up
• Routine COVID-19 vaccines for healthy younger adults, young children and pregnant people, in addition to older adults and immunocompromised individuals
• One-time RSV vaccines for those at high-risk, older adults (age 75+), pregnant people and all infants less than eight months without RSV vaccine protection during pregnancy

The coalition’s independent recommendations aim to fill the void left in the absence of guidance from the CDC. The Advisory Committee on Immunization Practices remains in limbo following a court ruling pausing the Trump administration’s prior efforts to reduce the number of vaccines children receive.

New data, released in conjunction with the coalition’s seasonal recommendations, show COVID-19, flu and RSV vaccines remain very safe and highly effective at protecting people of all ages against potentially life-threatening respiratory diseases.

The evidence-informed guidelines are medical groups’ latest attempt to calm confusion among the public related to vaccine misinformation, which has spiked in recent years following the COVID-19 pandemic and HHS’ controversial efforts to revamp vaccine policy.

– Rachel Bridges, Senior Director

• Sept. 7 – U.S. federal holiday, Labor Day

• “We still believe in these public health institutions and the public servants working under extraordinary pressure. But hope is not a strategy.” – Dr. Debra Houry et al., STAT
• “But assessing whether Trump’s deals deserve credit is made difficult by the fact that no one — including Congress, whom Trump again this week called on to codify the pacts — seems to know their precise terms.” – Lisa Jarvis, Bloomberg
• “Switches [from prescription to over the counter] may increase patient convenience and reduce some access barriers, but the promise of affordability depends on what replaces the current system.” – T. Joseph Mattingly II & Rena Conti, JAMA Health Forum
• “Negotiating discounts doesn’t require steering patients to your corporate affiliate. Processing claims doesn’t require spread pricing…Most importantly, saving taxpayers money doesn’t require preventing taxpayers from seeing the transaction.” – Vin Gopal & Doug Steinhardt, New Jersey Globe

• Congress approved a stopgap bill to fund the government through Dec. 11 that also pauses a proposed overhaul of federal grantmaking. STAT: House votes to temporarily block Trump plan to politicize federal grants.
• Early enrollment data from the Medicare GLP-1 Bridge program suggests strong demand for weight-loss medications among seniors—and new revenue for Eli Lilly. Fierce Pharma: Trump GLP-1 update teases blockbuster annual sales for Lilly from Medicare program: analyst.
• Mercer’s annual employer survey found health benefit costs are projected to rise 8.2% in 2027, driven by growing demand for GLP-1 medicines and specialty drugs. The New York Times: Employer Health Costs Are Expected to Spike in 2027.
• An HHS OIG audit found Medicare Part D spent hundreds of millions of dollars on over-the-counter drugs that were ineligible for coverage. Healthcare Dive: Medicare spent hundreds of millions of dollars on ineligible drugs, audit finds.
• Hospital groups are urging CMS to reconsider proposed cuts to 340B drug reimbursements and expanded site-neutral payment policies. Fierce Healthcare: Hospital groups rail against CMS’ proposed 340B changes, site-neutral payments.
• HHS has become a testing ground for the Trump administration’s effort to expand the number of political appointees in the federal workforce. Politico: RFK Jr.’s Health Department leads Trump’s push to add politicals to the federal workforce.
• The attorney general of Florida sued two PBMs, Prime Therapeutics and Express Scripts, alleging their longstanding partnership illegally suppressed pharmacy reimbursement rates. Florida Politics: James Uthmeier files lawsuit against 2 Pharmacy Benefit Managers amid allegations of price fixing.
• A year after several drugmakers scaled back UK investments, government reforms have helped ease some tensions about drug pricing and reimbursement policies. Fierce Biotech: A year on from Big Pharma’s pull-back from the UK, has anything changed?