Executive Order 13139— entitled ''Improving Health Protection of Military Personnel Participating in Particular Military Operations'' — as an

executive order In the United States, an executive order is a directive by the president of the United States that manages operations of the federal government. The legal or constitutional basis for executive orders has multiple sources. Article Two of the ...

(EO) issued by

U.S. President The president of the United States (POTUS) is the head of state and head of government of the United States. The president directs the Federal government of the United States#Executive branch, executive branch of the Federal government of t ...

Bill Clinton William Jefferson Clinton (né Blythe III; born August 19, 1946) is an American politician and lawyer who was the 42nd president of the United States from 1993 to 2001. A member of the Democratic Party (United States), Democratic Party, ...

on 30 September 1999. It outlines the conditions under which

Investigational New Drug The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical industry, pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug inte ...

(IND) and off-label pharmaceuticals can be administered to U.S. service members. An “off-label" indication is a use of a drug in a manner (or for a condition) other than that for which they were originally licensed. EO13139 provides the US

Secretary of Defense A ministry of defence or defense (see spelling differences), also known as a department of defence or defense, is the part of a government responsible for matters of defence and military forces, found in states where the government is divided ...

guidance regarding the provision of IND products or products unapproved for their intended use as antidotes to chemical, biological, or radiological weapons; stipulates that the U.S. government will administer products approved by the U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

only for their intended use; provides the circumstances and controls under which IND products may be used. It also stipulates that to administer an IND product, informed consent must be obtained from individual service members. However, the President of the United States may waive

informed consent Informed consent is an applied ethics principle that a person must have sufficient information and understanding before making decisions about accepting risk. Pertinent information may include risks and benefits of treatments, alternative treatme ...

(at the request of the Secretary of Defense and only the Secretary of Defense) if: *Informed consent is not feasible *Informed consent is contrary to the best interests of the service member *Obtaining informed consent is not in the best interests of national security. In the 2003 case of ''Doe v. Rumsfeld'',297 F.Supp.2d 119 (D.D.C. 2003). the

United States District Court for the District of Columbia The United States District Court for the District of Columbia (in case citations, D.D.C.) is a United States district court, federal district court in Washington, D.C. Along with the United States District Court for the District of Hawaii and ...

enjoined the

United States Air Force The United States Air Force (USAF) is the Air force, air service branch of the United States Department of Defense. It is one of the six United States Armed Forces and one of the eight uniformed services of the United States. Tracing its ori ...

from requiring administration of an unlicensed

anthrax vaccine Anthrax vaccines are vaccines to prevent the livestock and human disease anthrax, caused by the bacterium ''Bacillus anthracis''. They have had a prominent place in the history of medicine, from Pasteur's pioneering 19th-century work with cattle ...

to personnel pursuant to EO13139, noting that a waiver from the President had not been requested. This injunction dissolved in 2005, when the vaccine was licensed, and no longer considered experimental.

References

External links

EO13139 in the
''

Federal Register The ''Federal Register'' (FR or sometimes Fed. Reg.) is the government gazette, official journal of the federal government of the United States that contains government agency rules, proposed rules, and public notices. It is published every wee ...

''. {{U.S. biological defense 13139 Legal history of the United States 1999 in American law Biological warfare