On May 5, President Trump signed an executive order (EO) titled, "Regulatory Relief to Promote Domestic Production of Critical Medicines." The EO seeks to build on actions taken during the first Trump Administration to re-shore production of essential medicines and identifies the length of time that it takes to stand up new manufacturing capacity for drugs and critical inputs as a primary barrier to realizing a robust domestic pharmaceutical manufacturing base. (For more on the EO, see the White House fact sheet.)
Specifically, the EO:
- Directs the Commissioner of the Food and Drug Administration (FDA) and the Administrator of the Environmental Protection Agency to separately review regulations and guidance related to domestic pharmaceutical manufacturing and eliminate any duplicative or unnecessary requirements. The EO also requires these agency heads to take steps to improve the timeliness and predictability of their reviews and streamline and accelerate the development of domestic pharmaceutical manufacturing. This must be completed within 180 days of the order (November 1).
- Directs the FDA Commissioner to strengthen routine inspection of foreign manufacturing facilities and to fund these activities through raising fees on foreign facilities. This must be completed within 90 days (August 3).
- Directs the Assistant Secretary of the Army for Civil Works to determine whether an activity-specific nationwide permit is needed to facilitate the efficient permitting of domestic pharmaceutical manufacturing facilities. This must be completed within 180 days (November 1).
This announcement comes as the Administration considers imposing tariffs on pharmaceutical imports to promote domestic production of prescription drugs and the key ingredients and materials needed for those products. Separately, the White House released a fact sheet on May 8 touting recent commitments from drug and diagnostic companies to expand their footprint in the United States, with investments totaling around $230 billion.
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