EXECUTIVE ORDER 13139
(Bold and Colorized Text Added for My Emphasis)
IMPROVING HEALTH PROTECTION OF MILITARY PERSONNEL PARTICIPATING
IN PARTICULAR MILITARY OPERATIONS
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
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
(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 (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
(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;
(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.
(2) is contrary to the best interests of the member; or
(3) is not in the interests of national security.
(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.
(e) The Secretary shall develop the waiver request in consultation with
(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
(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.
(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.
(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
(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. 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;
(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.
(2) The means for tracking use and adverse effects of the investigational
(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).
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, (I.E., THE SKIRT-CHASING, POT-SMOKING, DRAFT DODGING,
THE WHITE HOUSE,
September 30, 1999.
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