Ensuring American Pharmaceutical Supply Chain Resilience By Filling The Strategic Active Pharmaceutical Ingredients Reserve

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The President orders actions to enhance domestic production of essential pharmaceutical products, referencing Executive Order 13944 from August 2020.
Agencies are directed to:
- Increase domestic procurement of essential medicines and identify supply chain vulnerabilities.
- The FDA published a list of essential medicines, later refined to 86 by the ASPR.
Current statistics:
- Nearly 40% of finished prescription drugs made in the U.S.
- Only about 10% of Active Pharmaceutical Ingredients (APIs) are domestically produced.
Creation of a Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) to stockpile APIs, aiming to:
- Insulate from foreign supply constraints, especially from adversary nations.
- Encourage domestic production through government purchases.
Criticism of the current Administration for not advancing domestic sources for essential medicines despite significant spending.

Within 30 days:
- ASPR to develop a list of 26 critical drugs and assess available funds for SAPIR.
- OMB to assist in fund repurposing.
Within 120 days:
- ASPR to prepare the existing SAPIR repository to maintain APIs.
6-month supply directive:
- ASPR to obtain a 6-month supply of APIs for critical drugs with a preference for domestic sources.
Within 90 days:
- ASPR to update the essential medicines list and present a plan to:
  - Obtain and maintain a 6-month supply of APIs.
  - Propose costs for a second SAPIR repository within one year.