ExecutiveOrdersEO
EO 13139Executive OrderClinton · D Quiet signal

Executive Order 13139

Improving Health Protection of Military Personnel Participating in Particular Military Operations

This executive order establishes procedures for administering investigational drugs to military personnel during particular military operations when FDA-approved alternatives are unavailable. It creates a detailed waiver process for informed consent requirements under 10 U.S.C. 1107(f), requiring presidential approval, FDA consultation, ongoing monitoring, and congressional notification.

Federal Register Open PDF 64 FR 54175

Impact dates

  1. Secretary to issue Federal Register public notice after waiver issued

  2. Secretary to make congressional notifications after waiver issued

  3. Waiver expires at end of 1 year (or alternative period not to exceed 1 year specified by President), or when operation ends, whichever is earlier

Key directives

  • Secretary of Defense shall collect intelligence on potential health threats and work with HHS on countermeasures (Sec. 2(a))
  • DoD must obtain informed consent before administering investigational drugs unless Secretary justifies waiver to President (Sec. 3(a))
  • President may waive informed consent upon written determination that consent is not feasible, contrary to member's best interests, or not in national security interests (Sec. 3(b))
  • Secretary may not delegate authority to make waiver requests; must include threat description, 21 CFR 50.23(d) compliance documentation, and IRB materials (Sec. 3(d))
  • Secretary shall develop waiver request in consultation with FDA (Sec. 3(e))
  • FDA Commissioner shall expeditiously review waiver request and certify to APNSA and APST (Sec. 3(g))
  • APNSA and APST shall prepare joint advisory opinion for President (Sec. 3(h))
  • DoD, OIG, and FDA shall conduct ongoing review and monitoring after waiver issued (Sec. 4(a))
  • Secretary shall make congressional notifications 'as soon as practicable' (Sec. 4(b))
  • Secretary shall issue Federal Register public notice 'as soon as practicable' (Sec. 4(c))
  • Waivers expire at 1 year or earlier; renewable with updated request (Sec. 4(d))
  • DoD shall provide ongoing training and health risk communication (Sec. 5(a))

Who is ordered

Timeline

Immediate

  • EO takes effect; establishes policy framework for investigational drug use in military operations

Near term (90d)

  • Secretary of Defense to develop waiver request procedures in consultation with FDA; training programs to be developed for chemical/biological warfare defense

Long term

  • Ongoing implementation of waiver protocols; annual review and potential renewal of waivers; continuous monitoring and reporting requirements

Risks & tensions

  • Tension between individual autonomy (informed consent) and military operational necessity; vague standard 'absolutely necessary' for waivers
  • Potential for classification requirements to limit public transparency despite Federal Register notice mandate
  • Unclear whether 'as soon as practicable' creates meaningful accountability for congressional notification
  • Highly discretionary presidential authority with limited external review; APNSA/APST advisory role is non-binding
  • Risk of mission impairment cited to justify incomplete compliance with 21 CFR 50.23(d) standards (Sec. 3(d)(2)(B))
  • Training requirements may be difficult to verify and enforce in rapidly deployed operational contexts
Executive Order 13139: Improving Health Protection of Military Personnel Participating in Particular Military Operations · Executive Orders