Pharmaceutical Resilience (E.O. 14336)

Summary

Requires the government to buy and store a six-month supply of the main ingredients for the most important medicines to make them in the U.S.

What problem does this solve?

The United States depends too much on other countries for the core ingredients needed to make important medicines. This order directs the government to create a stockpile of these ingredients, with a preference for those made in America, to ensure the country has them during an emergency.

Who does this affect?

U.S. pharmaceutical manufacturers
Department of Health and Human Services
American public

What does this order do?

Identifies the most critical medicines

Requires the government to create a list of about 26 drugs that are most important to the country's health and safety within 30 days.

Stockpiles a 6-month supply of medicine ingredients

Directs the government to buy a six-month supply of the active ingredients (APIs) needed to make the most critical drugs, preferably from U.S. makers.

Prepares the national ingredient reserve

Orders that the existing Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) be made ready to receive and store ingredients within 120 days.

Plans for a second reserve location

Requires a plan to be created that includes a cost estimate for opening a second SAPIR storage site in the U.S. within one year.

Updates the list of essential medicines

Requires the government to update its 2022 list of 86 essential medicines and create a plan to obtain and store a six-month supply of their ingredients.

What is the real world impact?

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Reverses the policies of the previous administration

Explicitly states that the 'Biden Administration failed to advance the goal' of securing domestic sources for medicines and that the national reserve is 'nearly empty,' positioning this order as a corrective action.

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Reduces reliance on foreign nations for medicine

Aims to protect the U.S. from supply chain problems caused by the 'concentration of foreign, sometimes adversary, nations' that produce key ingredients for medicines.

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Encourages American manufacturing

Uses government purchasing power to fill the national reserve, which can encourage more companies to produce medicine ingredients within the United States.

When does this start?

This order sets several deadlines for government agencies to complete specific tasks within the next year.

List of critical drugs

Within 30 days of August 13, 2025, a list of approximately 26 critical drugs must be developed.

Plan for essential medicines

Within 90 days of August 13, 2025, an updated list of 86 essential medicines and a plan to stockpile their ingredients must be provided.

Prepare the reserve

Within 120 days of August 13, 2025, the existing SAPIR repository must be ready to receive and maintain ingredients.

Proposal for second reserve

Within 1 year of August 13, 2025, a proposal and cost estimate for opening a second SAPIR repository must be completed.