Executive Order 13139: Improving Health Protection of Military Personnel Participating in Particular Military Operations
President: Bill Clinton
Set strict consent, notice, review and presidential-waiver rules for investigational or unapproved-use medical products in military operations.
Status: In effect. Is Executive Order 13139 still in effect? Yes. Executive Order 13139 remains in effect. See Federal Register record.
What does Executive Order 13139 do?
EO 13139 implements 10 U.S.C. 1107 for military use of investigational drugs or drugs unapproved for the intended use. DoD must ordinarily obtain informed consent, give extensive notice and training, track recipients and involve FDA. Only the President may waive consent after a written Defense request, and the order sets demanding necessity and risk criteria. The order remains reproduced with the current statute and in DoD force-health-protection policy.
Before and after
Before the order
Congress had required notice and reserved waiver authority to the President but implementation standards needed specification.
After the order
DoD received a formal process for consent, presidential waiver requests, FDA involvement, tracking and follow-up.
Who had to do what
| Agency / office | Action | Timing / position |
|---|---|---|
| Defense Secretary | Assess threats and seek approval or a presidential waiver when necessary | Continuing |
| President | Decide any informed-consent waiver | Case-specific |
| FDA Commissioner | Provide regulatory review and assistance | Continuing |
| DoD | Notify, train, track and monitor affected personnel | Continuing |
What happened next
EO 13139 established the implementation framework.
Legal and source detail
How it works legally
A waiver requires the statutory and executive findings and does not displace FDA law, constitutional constraints or other service-member protections. Product approval and a waiver of consent are distinct legal questions.
Sources by type
If a source is unavailable, first check the cited publisher or another official repository. The cited publisher remains the authority.
Primary and official sources
Orders, laws, court records and official implementation material.
- GovInfo — EO 13139 (opens in a new tab) Order text
How we checked this
Last checked against the sources above on October 2, 2026. How we research →