U.S. pricing and access policy shifted rapidly after President Donald Trump’s May 2025 executive order pushed voluntary adoption of Medicaid comparable pricing and best-available terms across major drugmakers. By the end of 2025, 14 of 17 large manufacturers had signed voluntary agreements, and participation expanded to about 89% of the branded market shortly after. An early signal of the policy’s impact is fewer new drug launches in EU markets, with one estimate placing the decline at roughly 35% year over year during the same period. Beyond U.S. developments, the article also points to tighter evidence expectations in Europe through the EU Joint Clinical Assessment process. Together with heightened scrutiny by HTA bodies such as NICE and Germany’s G-BA, which increasingly rely on real-world evidence, commercialization strategies are being forced to integrate regulatory, safety, and market-access planning earlier than before. Cencora’s Michael Day said leaders can no longer treat these steps sequentially.