President Trump’s August 10 executive order directs his administration to trim the universal childhood vaccine schedule from 18 to 11 diseases and requests that the combination MMR vaccine be split into three separate shots. The U.S. order reverberated globally.

The BBC reported that Trump justified the order by making four claims: that children in the U.S. receive too many shots; vaccine doses are unnecessarily large; administering MMR as three single vaccines is the recognized “gold standard”: and rising autism rates are tied to increased childhood vaccination.

A hive of fact-checkers, scientists, health officials and regulators, responded.

On safety, the BBC stated there is no causal link between vaccines and autism across decades of global studies, with rising diagnoses instead reflecting better screening and diagnostic criteria. The European Medicines Agency explained measles vaccines are rigorously tested and continuously monitored with no evidence of long-term harm. Merck and GSK said there is no published scientific evidence showing a benefit from splitting the MMR shot.

Furthermore, the Director-General of WHO highlighted that vaccine schedules for MMR are based on “decades of evidence,” emphasizing that delaying or separating doses leaves children unprotected and could lead to dangerous disease outbreaks. The Canadian Public Health Association shared this concern and moved to reaffirm their pediatric vaccine guidance remained unchanged.

Significant practical barriers in the way of putting this executive order into practice also came into light. Single disease shots for measles, mumps and rubella have not been available in the U.S. since Merck stopped making them in 2008. Reviving them would be a “major undertaking” with new clinical trials, FDA approvals and dedicated manufacturing facilities. Reuters reported that such a shift could take up to a decade—if it ever happens at all.

– Francesca Boldrini, Managing Director

Reactions on this side of the pond to President Trump’s new Executive Order were similarly swift across U.S. policymakers, advocates and industry. The move to again upend vaccine policy baffled most, as pollsters have waned about the topic being a political risk ahead of the Midterms.

Outgoing GOP Senators Bill Cassidy, R-La., and John Cornyn, R-Texas, called the order “wrong” and vehemently reinforced the safety and efficacy of vaccines. Multiple states and public health coalitions were also quick to condemn the order and reassure their residents that they would not change their current vaccine recommendations, and no changes to access or coverage have occurred.

All eyes are now on the newly confirmed CDC Director, Dr. Erica Schwartz, and how she will respond to this moment as her first test of leadership. Sen. Cassidy, who sparred with Schwartz during her nomination hearing, said he was confident that she would “do the right thing.” Schwartz was officially sworn in on Thursday and was not part of the order signing event three days earlier.

So, what does it all mean?

The immediate impacts of the Executive Order are minimal at this stage. The federal government does not have the power to mandate specific vaccines: only states do. Insurers have also indicated they will not change any coverage policies for vaccines recommended by the American Academy of Pediatrics. Manufacturers are clear that reverting to monovalent vaccines would be a massive undertaking requiring regulatory and manufacturing hurdles that could take a decade to solve.

Yet, despite its limited impact at present, the order has undoubtedly sown more chaos and confusion for the public. Public health experts, policymakers and providers will be on the front lines in the coming months trying to rebuild trust and confidence in the wake of past—and perhaps future—executive actions.

– Rachel Bridges, Senior Director

Readers of The Washington Post woke up to an encouraging headline Thursday morning: “Prescription drug prices record sharpest drop in more than 60 years.”

The source of the stat was the U.S. Bureau of Labor Statistics and its July inflation data, which showed prices for “medicinal drugs” fell 2.7% over a 12-month period. The White House quickly took credit for the drop, though experts warn that the department’s index is “increasingly disconnected” from the reality of drug spending.

Employers are the nexus of that reality, and many have been poring over claims data to optimize corporate health benefits. A new National Alliance survey found drug prices to be the top source of affordability barriers, prompting many to contract with pharmacy benefits managers outside of the three major players.

In response, large PBMs are trying transparency measures and contracting with a new partner. The Pharmaceutical Care Management Association and ten of its PBM members reached an agreement with the Trump administration to list the direct-to-patient prices of available drugs on TrumpRx alongside the prices on their respective benefit platforms.

“By making negotiated drug prices available alongside cash prices on TrumpRx, this agreement will give patients greater visibility into how much they’re paying and help them find the best possible deal,” said CMS Administrator Mehmet Oz. “That’s the kind of transparency we need to boost competition, drive down costs, and deliver better value for American patients.”

– Andrew Wishon, Editor-in-Chief

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• “The administration is right that trust matters more than compulsion alone. But trust is not created by making established recommendations look provisional, adding barriers to care, or asking parents to navigate conflicting signals.” – Katrine Wallace, STAT
• “[The 340B rebate model] would hand the drug manufacturers unprecedented power over the safety-net healthcare system. They would assume authority over which medications, which patients, and which clinics qualify for a discount; decisions that have always belonged to doctors, patients, and clinics themselves.” – Emily Blaiklock, POZ
• “The bottom line is that IRA may not just make future health more expensive by cutting innovation into new drugs but in addition raise the price of existing drugs. To call that a victory for patients is misleading on both fronts.” – Tomas J. Philipson, RealClearHealth

• Pharma companies are pulling back on Swiss reimbursement filings amid concerns that lower prices in the country could influence U.S. drug pricing under the Trump administration. Reuters: Drugmakers curb Swiss reimbursement applications over US pricing concerns.
• Congress is weighing three competing 340B reform proposals, with lawmakers split over whether rebates should be prohibited, temporarily paused or formally incorporated into the program. 340B Report: How Three Different Congressional Bills Would Address 340B Rebates.
• FDA unveiled its proposed user fee framework for patented drugs, pairing review process enhancements with new incentives for U.S.-based clinical research and manufacturing. Regulatory Focus: PDUFA VIII: FDA outlines goals, program enhancements in commitment letter.
• Several groups urged the U.S. Trade Representative to close its Section 301 investigation of German pharmaceutical pricing policies, arguing that rebates apply equally to domestic and foreign manufacturers. Inside Health Policy: Stakeholders Defend German Pharma Law Amid Tariff Threat.
• FDA’s proposed generics user fee agreement would add incentives for domestic drug manufacturing and review process enhancements aimed at reducing supply chain risks. Regulatory Focus: GDUFA IV: Commitment letter outlines key changes to program.
• More than 80% of the most innovative drugs approved in China since 2020 have been added to the country’s national reimbursement list. Pink Sheet: Does China Reimburse Its Most Innovative Drugs?
• Snapchat unveiled a new ad format that allows pharmaceutical companies to include up to three disclosure links alongside a primary call-to-action. Fierce Pharma: Snapchat creates ad format to support pharma disclosure needs.