President Donald Trump has signed an executive order aimed at increasing domestic production and stockpiling of essential drug components by directing the government to fill the nation’s Strategic Active Pharmaceutical Ingredients Reserve.
This comes after President Trump recently floated a tariff on pharmaceuticals as high as 250% in an interview with CNBC’s “Squawk Box” as part of a push to bring more drug manufacturing into the U.S. This also follows a Section 232 investigation that was launched in April, allowing the secretary of commerce to determine whether pharmaceutical imports pose a threat to national security.
Here are five notes:
- Only around 10% of APIs used in finished drug products in the U.S. are made domestically with the rest largely sourced from foreign suppliers, according to an Aug. 13 White House news release.
- Within 30 days, the HHS assistant secretary for preparedness and response is required to develop a list of around 26 drugs that are deemed critical for national health and security purposes.
- The ASPR is also required to obtain and store a six-month supply of APIs for selected critical drugs and the existing SAPIR facility must be ready to receive APIs within 120 days.
- The order also instructs the ASPR to submit an updated plan for a broader list of 86 essential medications and a proposal to open a second SAPIR facility in a year.
- While the order does not request congressional appropriations, it directs agencies to identify existing funds that can be repurposed to help finance SAPIR operations with help from the Office of Management and Budget, the release said.