Last week, President Trump issued another executive order with potential to impact drug manufacturers and patients. Here’s what you need to know.
Dubbed the “Buy American” order, the goal is to increase domestic manufacture of “essential medicines,” “medical countermeasures,” and “critical inputs,” and in turn, decrease America’s reliance on medicines manufactured in foreign countries.
What it doesn’t do: The order does not require any manufacturer to physically move production of any particular medicines back to the United States.
What it does do: It incentivizes production in the United States by directing federal agencies involved in contracting for these products to apply preferences aimed at increasing domestic procurement of them. However, agency heads can waive the preferences if sufficient supplies do not exist domestically, or if a number of other exceptions apply.
The order specifically directs the Food and Drug Administration (FDA) to accelerate review and approval of domestically manufactured essential medicines. We anticipate FDA would need to issue some guidance on this in the future.
It might affect trade, too. The order directs the U.S. Trade Representative (USTR) to modify trade agreements to allow preferential procurement of domestically produced products and allow tariffs on imported medicines. And yes, this could trigger reciprocal action or even tariffs from trading partners.
What’s next? We expect affected agencies (FDA, HHS, DoD, USTR) to engage in some kind of public dialogue about the implementation, so stay tuned. In the meantime, BIO will continue to work with our allies to mitigate the impacts on our sector and the patients we serve—and articulate why a resilient, diverse, dynamic supply chain is critical to ensuring access to medicines, in normal times and in emergencies.
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