On August 13, President Trump issued an executive order (EO) directing the Department of Health and Human Services' (HHS) Administration for Preparedness and Response (ASPR) to make new purchases of active pharmaceutical ingredients (API) for the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), established during the first Trump Administration. Specifically, the EO directs ASPR and other administration officials to identify "approximately 26 critical drugs," determine available funds to begin obtaining a six-month supply of the API for these products, and ready the SAPIR for receiving these materials. For the SAPIR purchases, the EO provides a preference for domestically manufactured API "if possible," stating that "only about 10 percent of the APIs by volume for the finished drug products used in the United States" are made domestically.
Efforts to develop a SAPIR began as part of changes made to the HHS Strategic National Stockpile in 2020, including a contract awarded to support domestically manufactured API. In response to an August 2020 EO, the first Trump Administration developed an initial list of critical medicines published by the Food and Drug Administration (FDA) in October 2020 and updated in an assessment by ASPR in 2022. The new EO directs the Administration to update that list.
The new SAPIR EO comes amid ongoing administration efforts to increase domestic production of pharmaceuticals and related materials. While the Administration has not announced major new financial commitments to onshore manufacturing of pharmaceuticals or API, ASPR has recently highlighted investments made during the first Administration to support domestic API and finished pharmaceutical production.
The FDA also recently announced a new "FDA PreCheck" program to streamline regulatory processes for domestic pharmaceutical manufacturing sites, in response to a May EO directing regulatory relief to promote domestic pharmaceutical manufacturing.1 (In April, the Department of Commerce announced an investigation of potential national security concerns raised by reliance on imports of pharmaceuticals, API, and key starting materials, and the President has stated that the investigation's report and planned tariffs on pharmaceuticals, including potentially a phased-in approach to such tariffs, will be announced soon.)
Footnote
1 Manatt on Health subscribers can see the August 11 edition of Insights This Week for more on the FDA PreCheck program.
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