Executive Order 13139

Executive Order 13139

Executive Order 13139 is a directive issued by the President of the United States, which pertains to the administration of investigational new drugs to members of the armed forces. This order was signed by President Bill Clinton on September 30, 1999.

Purpose

The primary purpose of Executive Order 13139 is to establish guidelines and procedures for the use of investigational new drugs and biologics in military personnel. This is particularly relevant in situations where military members may be exposed to chemical, biological, or radiological threats, and where standard treatments may not be available or effective.

Key Provisions

Informed Consent

One of the central provisions of Executive Order 13139 is the requirement for informed consent. This means that military personnel must be fully informed about the investigational drug or treatment, including its potential risks and benefits, and must voluntarily agree to its use.

Waiver of Informed Consent

The order also outlines circumstances under which the requirement for informed consent can be waived. This can occur if obtaining consent is not feasible, if the investigational drug is necessary to protect the health of the service member, and if the use of the drug is in the best interest of the individual.

Oversight and Review

Executive Order 13139 mandates that the use of investigational drugs in the military be subject to rigorous oversight and review. This includes the establishment of an Institutional Review Board (IRB) to evaluate the ethical and scientific aspects of the proposed use of such drugs.

Implementation

The implementation of Executive Order 13139 involves coordination between various government agencies, including the Department of Defense and the Food and Drug Administration (FDA). These agencies are responsible for ensuring that the investigational drugs are administered safely and ethically.

Impact

The impact of Executive Order 13139 has been significant in shaping the policies and procedures for the use of investigational drugs in the military. It has provided a framework for balancing the need for rapid medical responses in combat situations with the ethical considerations of informed consent.

Criticism and Controversy

Executive Order 13139 has faced criticism and controversy, particularly regarding the waiver of informed consent. Critics argue that waiving consent could lead to ethical dilemmas and potential abuses, while proponents emphasize the necessity of such measures in emergency situations.

See Also

• Investigational New Drug
• Informed Consent
• Institutional Review Board
• Department of Defense