Just over a year ago, President Trump sent letters to 17 of the world’s largest pharmaceutical manufacturers demanding they provide American patients with prices comparable to the lowest prices available in other developed countries. What followed was a year of intense lobbying, negotiation and dealmaking that reshaped the drug pricing debate.

Now, all 17 companies have signed Most Favored Nation pricing agreements with the White House, covering roughly 86% of the branded U.S. market. Under the deals, manufacturers committed to MFN pricing in Medicaid and participation in direct-to-patient discount programs such as TrumpRx. In exchange, drugmakers secured a three-year reprieve from sector-specific tariffs — upon making substantial commitments to U.S. manufacturing and research.

The deals delivered significant discounts on certain products sold through TrumpRx, particularly among obesity and fertility treatments, but largely left underlying list prices untouched. Several companies subsequently increased list prices on existing products, underscoring that the agreements focused on targeted discounts rather than broad price reductions.

The policy’s impact extends far beyond the United States. From the outset, the administration argued that Americans should no longer bear a disproportionate share of global pharmaceutical profits, “ending global freeloading.” The White House explicitly sought to create leverage for manufacturers to negotiate higher prices in overseas markets, and in late 2025 announced an agreement with the United Kingdom to increase net prices on new medicines.

At the same time, industry leaders and analysts warn that MFN policies are changing launch and investment decisions in Europe and beyond. Pharma companies have discussed withholding or delaying launches in lower-priced markets, while one analysis found drug launches in key European reference countries declined 43% following the executive order.

An ongoing question — and one reupped this week by two former Congressmen in a bipartisan The Hill op-ed — is whether MFN survives beyond the current administration and is codified into law. With midterms on the horizon, and lower drug pricing having bipartisan support, it’s unlikely that Congress will give the White House the win.

– Megan Hickey, Managing Director

Last Friday, HRSA unveiled a retooled rebate pilot that would replace upfront discounts in the 340B Drug Pricing Program with manufacturer-paid rebates. Set to launch January 1, 2027, the agency is seeking to pre-empt an appearance in court by holding a formal comment period, a procedural step that prompted a federal judge to halt the first pilot.

The revised pilot covers as many as 25 drugs from 13 manufacturers, all tied to the first two rounds of Medicare drug price negotiations. That’s up from 10 drugs and eight companies in the original design, though HRSA was quick to note the covered products represent less than 5.5% of total 340B sales.

HRSA Administrator Tom Engels framed the expansion as a transparency play, arguing it will bring much-needed visibility to a program that surpassed $100 billion in annual purchases in 2025. Manufacturers have made that same case for years, and they welcomed the announcement accordingly. PhRMA called it “a positive step” and pushed HRSA to extend the rebate model across the full program, while the National Pharmaceutical Council said it addresses a program “growing out of control.”

Not surprisingly, hospital groups landed loudly on the opposite side. The American Hospital Association and 340B Health argued HRSA has badly underestimated the administrative and cash-flow burden the rebate model would place on safety-net providers, who depend on the speed of upfront discounts to fund care for underserved populations. Both organizations signaled they are weighing legal action, though attorneys tracking the issue note that HRSA’s procedural fix makes this version a tougher target than its predecessor.

Now everyone is up against the clock; manufacturer rebate plans are due to HRSA by August 24, and approvals are expected by late September. That leaves roughly three months between approval and launch — not much runway for the operational and contracting changes covered entities will need to absorb. Whether that timeline holds, or becomes its own flashpoint, may depend on what happens in court first.

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

Vaccines have been a hot topic in the health policy space all summer long, and this week has been no exception. See below for a rundown of the latest vaccines news.

• FDA Reverses Course on Moderna’s mRNA Flu Shot: The FDA approved Moderna’s mRNA flu shot, mFlusiva, for people ages 65 and older. The decision was an about-face from just six months ago when the FDA issued a refusal to file letter over concerns about Moderna’s Phase 3 trial. The first-of-its-kind flu shot offers a faster and more easily targeted option compared to other types of flu vaccines, featuring mRNA technology open questioned by HHS Secretary Kennedy.
• Dr. Erica Schwartz Confirmed as CDC Director: After a contentious committee hearing, the Senate voted to confirm Dr. Erica Schwartz as the new head of the CDC in a mostly party-line 51-44 vote. Dr. Schwartz takes the helm after an almost year-long vacancy at the CDC amid the largest U.S. measles outbreak in 35 years, and other public health crises like the ongoing cyclospora and Ebola outbreaks.
• Rumors Swirl on Autism Executive Order: Reports indicate that the Trump administration may soon release an Executive Order linking vaccines and autism, though specific timing and language of the order could not be confirmed. This would mark a departure from the White House, which has pivoted away from vaccine policy following warnings of political risk from Republican pollsters. Insiders are saying autism is a personal focus for President Trump, who is pressuring HHS Secretary Kennedy for answers even without a proven causal link.

– Rachel Bridges, Senior Director

• No relevant upcoming events

• “HHS doesn’t say how many shows RFK Jr. will air, nor how often. Good. He should stop with this one. It’s embarrassingly bad. As secretary, he has much more important things to do.” – Bill Press, The Hill
• “If government officials want to avoid questions of impropriety, they need to go out of their way to show that they will not personally benefit from their own policies.” – Editorial Board, The Washington Post
• “That’s $58 million in public money that should have gone toward helping sick people afford their medicine. Instead, it paid for a Bentley, a Mercedes, and a $2.5 million mansion on the coast.” – Skylar Zander, Orlando Sentinel
• “American patients are, in effect, subsidizing pharmaceutical access for German ones…This is not a market outcome. It is coordinated free-riding, and it demands a trade response.” – Jack Kalavritinos, The Washington Times

• Replimune’s Tudriqev won FDA approval to treat advanced melanoma and will launch at a list price of $450,000 per course of therapy. STAT: FDA approves Replimune melanoma drug previously rejected twice.
• Bank of America CEO Brian Moynihan said the company is spending more than $250 million annually to provide GLP-1 medicines for weight loss to its workforce. CNBC: Bank of America spends $250 million a year on GLP-1 drugs for its employees, CEO says.
• A Health Affairs analysis determined expanded orphan-drug exemptions from Medicare drug price negotiations may be unwarranted because most affected drugs recover trial costs quickly and resemble non-orphan drugs financially. STAT: The latest orphan drug exemptions may not be warranted, analysis finds.
• Through Amazon Pharmacy, patients on Medicare Part D with a clinician’s prescription will have access to GLP-1 medicines for $50 a month with free home delivery. The Wall Street Journal: Amazon to Offer GLP-1 Weight-Loss Drugs to Medicare Part D Patients.
• CMS projections suggest Medicare will finance increasingly large amounts of the U.S. prescription drug market, in large part due to the IRA’s Part D redesign. Drug Channels: Who Will Pay for Prescription Drugs in 2034? Medicare’s Surprising Rise in the Latest Government Forecasts.
• India’s pharmaceutical industry is likely to miss its sales target for the end of the decade as U.S. tariff uncertainty and Middle East ​shipping disruptions weigh on exports. Reuters: India pharma sector to miss 2030 sales target amid tariff and shipping woes, trade body says.
• California’s Supreme Court ruled Gilead Sciences will not face negligence claims for halting development of a drug candidate more than 20 years ago. Fierce Pharma: Drugmakers don’t have ‘duty to innovate’, California court rules, backing Gilead in HIV drug litigation.