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EO 13944Executive OrderTrump 45 · R Quiet signal

Executive Order 13944

Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States

This executive order directs federal agencies to prioritize domestic procurement of essential medicines, medical countermeasures, and their critical ingredients to reduce dependence on foreign manufacturing. It mandates supply chain vulnerability assessments, streamlines regulatory approvals for domestic producers, and authorizes use of the Defense Production Act to prioritize these materials. The order includes exceptions for public health emergencies and when domestic procurement would increase costs by more than 25 percent.

Federal Register Open PDF 85 FR 49929

Impact dates

  1. First annual agency procurement reports due

  2. HHS identifies and mitigates supply chain vulnerabilities

  3. DoD identifies defense-specific supply chain vulnerabilities and provides list

  4. Commerce report on Public Health Industrial Base status

  5. DoD restricts procurement to domestic sources and rejects Qualifying Country offers (60 days after FDA list)

  6. USTR modifies procurement coverage under FTAs and WTO GPA (30 days after FDA list)

  7. OMB review of e-commerce platform procurement authority and report to President

  8. Agency heads develop and implement procurement strategies

  9. FDA Commissioner identifies initial list of Essential Medicines, Medical Countermeasures, and Critical Inputs

Key directives

  • Agencies shall limit competition to domestically produced Essential Medicines, Medical Countermeasures, and Critical Inputs where permitted by law
  • Agencies shall divide procurement requirements among multiple US manufacturers
  • FDA Commissioner to identify initial list of Essential Medicines, Medical Countermeasures, and Critical Inputs within 90 days
  • USTR to modify FTA and WTO procurement coverage to exclude listed products within 30 days of FDA list
  • DoD to restrict procurement to domestic sources and reject Qualifying Country offers within 60 days of FDA list
  • HHS to identify and mitigate supply chain vulnerabilities within 180 days
  • EPA to streamline requirements for Advanced Manufacturing facilities
  • HHS Secretary authorized to use DPA prioritization and allocation authority
  • Annual agency procurement reports due starting December 15, 2021
  • Commerce report on Public Health Industrial Base due within 180 days

Who is ordered

Timeline

Immediate

  • Policy declaration on domestic production preference
  • Authorization of DPA prioritization authority for HHS Secretary

Near term (90d)

  • OMB review of e-commerce platform procurement restrictions
  • Agency procurement strategies due
  • FDA Commissioner initial list of Essential Medicines/Medical Countermeasures/Critical Inputs
  • USTR action to modify procurement coverage after FDA list (30 days after FDA list)
  • DoD restriction on Qualifying Country sources (60 days after FDA list)

Long term

  • HHS supply chain vulnerability assessment (180 days)
  • DoD defense-specific supply chain assessment (180 days)
  • Commerce report on Public Health Industrial Base status (180 days)
  • Annual agency procurement reports starting December 15, 2021
  • Ongoing regulatory streamlining for Advanced Manufacturing

Risks & tensions

  • 25% cost increase threshold may create implementation ambiguity; 'applicable law requires a higher percentage' clause adds complexity
  • DoD restriction on 'Qualifying Countries' conflicts with existing defense trade relationships
  • WTO GPA and FTA modifications risk trade disputes with treaty partners
  • Definition of 'produced in the United States' requires both Critical Inputs and finished products be domestic, setting high bar
  • Public interest and emergency exceptions in section 2(f) may substantially limit practical effect
  • Veterans price protection creates tension with domestic production cost premiums
  • Annual reporting requirement begins 2021-12-15 but covers 'preceding three fiscal years' — data availability uncertainty for earlier periods
Executive Order 13944: Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States · Executive Orders