Overview

• The program’s first phase establishes regular FDA consultations on facility design, construction and pre-production planning to reduce duplicative requirements.
• The second phase offers pre-application meetings and early feedback on chemistry, manufacturing and controls submissions to boost regulatory predictability.
• The plan responds to a May executive order directing the FDA to cut duplicative reviews and follows President Trump’s threat to impose up to 250 percent tariffs on imported drugs to spur onshoring.
• More than half of U.S. medicines and active pharmaceutical ingredients currently come from overseas, underpinning national security and resilience goals of the domestic push.
• Major firms including Eli Lilly, AstraZeneca and Johnson & Johnson have pledged over $130 billion in new and expanded U.S. manufacturing investments, though new facilities may take years to come online.