Improving Health Protection of Military Personnel Participating in Particular Military Operations

Executive Order 13139 of September 30, 1999

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 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 (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:
    L(1) is not feasible;
    L(2) is contrary to the best interests of the
member; or
    L(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:
    L(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.
    L(2) Documentation that the Secretary has complied
with 21 CFR 50.23(d). This documentation shall include:

  L(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

  L(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.

    L(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.
    (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. Training and health risk
communication shall include at a minimum:
    L(1) The basis for any determination by the
President that informed consent is not or may not be
feasible;
    L(2) The means for tracking use and adverse effects
of the investigational drug;
    L(3) The benefits and risks of using the
investigational drug; and
    L(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.

    (Presidential Sig.)

THE WHITE HOUSE,

     September 30, 1999.