Trump signed an executive order on April 2 slapping 100% tariffs on imported patented pharmaceuticals and their active ingredients — invoking Section 232 national security authority for the first time against the drug industry.
The carve-outs matter as much as the tariff itself. Companies that cut MFN pricing deals with HHS and commit to U.S. manufacturing pay zero until January 2029. Domestic-only commitments get you to 20%, scaling up to 100% by 2030. Biosimilars and generics are out for now, with a one-year reassessment. The EU, Japan, South Korea, and Switzerland face 15%. Britain gets a lower rate tied to its recent pricing agreement.
Every branded drug company without a U.S. manufacturing footprint now has a hard deadline. The order doesn’t ask nicely: it prices them out if they don’t move. That’s not a nudge. Companies treating this as a transitional phase are making a bet they can’t afford to lose; the structural shift has already happened.
Pfizer and BioNTech had their own bad week. They halted a post-marketing Covid-19 vaccine study in healthy adults aged 50 to 64, citing enrollment shortfalls: the trial needed 25,000 to 30,000 participants with no chronic conditions and couldn’t get there. Enrollment closed March 6. No safety issue, just a study that couldn’t fill its seats.
Biosimilars and generics get a one-year window before the tariff regime reassesses. After that, no guarantees.