Presidential Determination and Waiver Pursuant to Section 303 of the Defense Production Act of 1950, as Amended, on Essential Medicines, Medical Countermeasures, and Critical Inputs

This determination invokes the Defense Production Act to expand domestic production of essential medicines, medical countermeasures, and critical inputs for national defense. It waives certain statutory requirements (sections 303(a)(5)-(a)(6)) to expedite building domestic manufacturing capacity, relying on product lists established under Executive Order 13944 from the prior administration.

Federal Register Open PDF 89 FR 3

Impact dates

Dec 27, 2023
Scope limited to items identified under EO 13944 section 3(c) as of this date

Key directives

Invoke DPA Section 303 for essential medicines, medical countermeasures, and critical inputs
Waive requirements of section 303(a)(5)-(a)(6) to expand domestic production
Limit scope to items identified under EO 13944 section 3(c) as of December 27, 2023
Publish determination in Federal Register

Who is ordered

Secretary of Health and Human Services · Department of Health and Human Services

Timeline

Immediate

DPA authority invoked for essential medicines and medical countermeasures
waiver of section 303(a)(5)-(a)(6) requirements takes effect

Near term (90d)

HHS implementation of projects to expand domestic production capabilities
Federal Register publication

Long term

Potential expansion of domestic pharmaceutical manufacturing capacity
Reduced dependency on foreign-sourced critical medical inputs

Risks & tensions

Waiver reduces normal procedural safeguards; cost-effectiveness findings bypassed
Scope tied to EO 13944 list from prior administration—unclear if updated
Subject to appropriations availability, limiting actual implementation
Potential tension with pharmaceutical industry over mandatory production priorities