[Weekly Compilation of Presidential Documents Volume 35, Number 39 (Monday, October 4, 1999)]
[Pages 1875-1878]
[Online from the Government Publishing Office, www.gpo.gov]

<R04>
Executive Order 13139--Improving Health Protection of Military Personnel 
Participating in Particular Military Operations

September 30, 1999

    By the authority vested in me as President by the Constitution and 
the laws of the United States of America, including section 1107 of 
title 10, United States Code, and in order to provide the best health 
protection to military personnel participating in particular military 
operations, it is hereby ordered as follows:
    Section 1. Policy. Military personnel deployed in particular 
military operations could potentially be exposed to a range of chemical, 
biological, and radiological weapons as well as diseases endemic to an 
area of operations. It is the policy of the United States Government to 
provide our military personnel with safe and effective vaccines, 
antidotes, and treatments that will negate or minimize the effects of 
these health threats.
    Sec. 2. Administration of Investigational New Drugs to Members of 
the Armed Forces.
    (a) The Secretary of Defense (Secretary) shall collect intelligence 
on potential health threats that might be encountered in an area of 
operations. The Secretary shall work together with the Secretary of 
Health and Human Services to ensure appropriate countermeasures are 
developed. When the Secretary considers an investigational new drug or a 
drug unapproved for its intended use

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(investigational drug) to represent the most appropriate countermeasure, 
it shall be studied through scientifically based research and 
development protocols to determine whether it is safe and effective for 
its intended use.
    (b) It is the expectation that the United States Government will 
administer products approved for their intended use by the Food and Drug 
Administration (FDA). However, in the event that the Secretary considers 
a product to represent the most appropriate countermeasure for diseases 
endemic to the area of operations or to protect against possible 
chemical, biological, or radiological weapons, but the product has not 
yet been approved by the FDA for its intended use, the product may, 
under certain circumstances and strict controls, be administered to 
provide potential protection for the health and well-being of deployed 
military personnel in order to ensure the success of the military 
operation. The provisions of 21 CFR Part 312 contain the FDA 
requirements for investigational new drugs.
    Sec. 3. Informed Consent Requirements and Waiver Provisions.
    (a) Before administering an investigational drug to members of the 
Armed Forces, the Department of Defense (DoD) must obtain informed 
consent from each individual unless the Secretary can justify to the 
President a need for a waiver of informed consent in accordance with 10 
U.S.C. 1107(f). Waivers of informed consent will be granted only when 
absolutely necessary.
    (b) In accordance with 10 U.S.C. 1107(f), the President may waive 
the informed consent requirement for the administration of an 
investigational drug to a member of the Armed Forces in connection with 
the member's participation in a particular military operation, upon a 
written determination by the President that obtaining consent:
(1)         is not feasible;
(2)         is contrary to the best interests of the member; or
(3)         is not in the interests of national security.
    (c) In making a determination to waive the informed consent 
requirement on a ground described in subsection (b)(1) or (b)(2) of this 
section, the President is required by law to apply the standards and 
criteria set forth in the relevant FDA regulations, 21 CFR 50.23(d). In 
determining a waiver based on subsection (b)(3) of this section, the 
President will also consider the standards and criteria of the relevant 
FDA regulations.
    (d) The Secretary may request that the President waive the informed 
consent requirement with respect to the administration of an 
investigational drug. The Secretary may not delegate the authority to 
make this waiver request. At a minimum, the waiver request shall 
contain:
(1)         A full description of the threat, including the potential 
            for exposure. If the threat is a chemical, biological, or 
            radiological weapon, the waiver request shall contain an 
            analysis of the probability the weapon will be used, the 
            method or methods of delivery, and the likely magnitude of 
            its affect on an exposed individual.
(2)         Documentation that the Secretary has complied with 21 CFR 
            50.23(d). This documentation shall include:
(A)         A statement that certifies and a written justification that 
            documents that each of the criteria and standards set forth 
            in 21 CFR 50.23(d) has been met; or
(B)         If the Secretary finds it highly impracticable to certify 
            that the criteria and standards set forth in 21 CFR 50.23(d) 
            have been fully met because doing so would significantly 
            impair the Secretary's ability to carry out the particular 
            military mission, a written justification that documents 
            which criteria and standards have or have not been met, 
            explains the reasons for failing to meet any of the criteria 
            and standards, and provides additional justification why a 
            waiver should be granted solely in the interests of national 
            security.
(3)         Any additional information pertinent to the Secretary's 
            determination, including the minutes of the Institutional 
            Review Board's (IRB) deliberations and the IRB members' 
            voting record.
    (e) The Secretary shall develop the waiver request in consultation 
with the FDA.

[[Page 1877]]

    (f) The Secretary shall submit the waiver request to the President 
and provide a copy to the Commissioner of the FDA (Commissioner).
    (g) The Commissioner shall expeditiously review the waiver request 
and certify to the Assistant to the President for National Security 
Affairs (APNSA) and the Assistant to the President for Science and 
Technology (APST) whether the standards and criteria of the relevant FDA 
regulations have been adequately addressed and whether the 
investigational new drug protocol may proceed subject to a decision by 
the President on the informed consent waiver request. FDA shall base its 
decision on, and the certification shall include an analysis describing, 
the extent and strength of the evidence on the safety and effectiveness 
of the investigational new drug in relation to the medical risk that 
could be encountered during the military operation.
    (h) The APNSA and APST will prepare a joint advisory opinion as to 
whether the waiver of informed consent should be granted and will 
forward it, along with the waiver request and the FDA certification to 
the President.
    (i) The President will approve or deny the waiver request and will 
provide written notification of the decision to the Secretary and the 
Commissioner.
    Sec. 4. Required Action After Waiver is Issued. (a) Following a 
Presidential waiver under 10 U.S.C. 1107(f), the DoD offices responsible 
for implementing the waiver, DoD's Office of the Inspector General, and 
the FDA, consistent with its regulatory role, will conduct an ongoing 
review and monitoring to assess adherence to the standards and criteria 
under 21 CFR 50.23(d) and this order. The responsible DoD offices shall 
also adhere to any periodic reporting requirements specified by the 
President at the time of the waiver approval. The Secretary shall submit 
the findings to the President and provide a copy to the Commissioner.
    (b) The Secretary shall, as soon as practicable, make the 
congressional notifications required by 10 U.S.C. 1107(f)(2)(B).
    (c) The Secretary shall, as soon as practicable and consistent with 
classification requirements, issue a public notice in the Federal 
Register describing each waiver of informed consent determination and a 
summary of the most updated scientific information on the products used, 
as well as other information the President determines is appropriate.
    (d) The waiver will expire at the end of 1 year (or an alternative 
time period not to exceed 1 year, specified by the President at the time 
of approval), or when the Secretary informs the President that the 
particular military operation creating the need for the use of the 
investigational drug has ended, whichever is earlier. The President may 
revoke the waiver based on changed circumstances or for any other 
reason. If the Secretary seeks to renew a waiver prior to its 
expiration, the Secretary must submit to the President an updated 
request, specifically identifying any new information available relevant 
to the standards and criteria under 21 CFR 50.23(d). To request to renew 
a waiver, the Secretary must satisfy the criteria for a waiver as 
described in section 3 of this order.
    (e) The Secretary shall notify the President and the Commissioner if 
the threat countered by the investigational drug changes significantly 
or if significant new information on the investigational drug is 
received.
    Sec. 5. Training for Military Personnel. (a) The DoD shall provide 
ongoing training and health risk communication on the requirements of 
using an investigational drug in support of a military operation to all 
military personnel, including those in leadership positions, during 
chemical and biological warfare defense training and other training, as 
appropriate. This ongoing training and health risk communication shall 
include general information about 10 U.S.C. 1107 and 21 CFR 50.23(d).
    (b) If the President grants a waiver under 10 U.S.C. 1107(f), the 
DoD shall provide training to all military personnel conducting the 
waiver protocol and health risk communication to all military personnel 
receiving the specific investigational drug to be administered prior to 
its use.
    (c) The Secretary shall submit the training and health risk 
communication plans as part of the investigational new drug protocol 
submission to the FDA and the reviewing IRB.

[[Page 1878]]

Training and health risk communication shall include at a minimum:
(1)         The basis for any determination by the President that 
            informed consent is not or may not be feasible;
(2)         The means for tracking use and adverse effects of the 
            investigational drug;
(3)         The benefits and risks of using the investigational drug; 
            and
(4)         A statement that the investigational drug is not approved 
            (or not approved for the intended use).
    (d) The DoD shall keep operational commanders informed of the 
overall requirements of successful protocol execution and their role, 
with the support of medical personnel, in ensuring successful execution 
of the protocol.
    Sec. 6. Scope. (a) This order applies to the consideration and 
Presidential approval of a waiver of informed consent under 10 U.S.C. 
1107 and does not apply to other FDA regulations.
    (b) This order is intended only to improve the internal management 
of the Federal Government. Nothing contained in this order shall create 
any right or benefit, substantive or procedural, enforceable by any 
party against the United States, its agencies or instrumentalities, its 
officers or employees, or any other person.
                                            William J. Clinton
The White House,
September 30, 1999.

[Filed with the Office of the Federal Register, 8:45 a.m., October 4, 
1999]

Note: This Executive order will be published in the Federal Register on 
October 5.