TITLE 10, Subtitle A, PART II, CHAPTER 55,
Sec. 1107. - Notice of use of an investigational new drug or a drug unapproved for its applied use
(a) Notice Required. -
(1)
Whenever the Secretary of Defense requests or requires a member of the armed forces to receive an investigational new drug or
a drug unapproved for its applied use, the Secretary shall provide the member with notice containing the information
specified in subsection (d).
(2)
The Secretary shall also ensure that health care providers who administer an investigational new drug or a drug unapproved
for its applied use, or who are likely to treat members who receive such a drug, receive the information required to be
provided under paragraphs (3) and (4) of subsection (d).
(b) Time of Notice. -
The notice required to be provided to a member under subsection (a)(1) shall be provided before the investigational new drug
or drug unapproved for its applied use is first administered to the member.
(c) Form of Notice. -
The notice required under subsection (a)(1) shall be provided in writing.
(d) Content of Notice. -
The notice required under subsection (a)(1) shall include the following:
(1)
Clear notice that the drug being administered is an investigational new drug or a drug unapproved for its applied use.
(2)
The reasons why the investigational new drug or drug unapproved for its applied use is being administered.
(3)
Information regarding the possible side effects of the investigational new drug or drug unapproved for its applied use,
including any known side effects possible as a result of the interaction of such drug with other drugs or treatments being
administered to the members receiving such drug.
(4)
Such other information that, as a condition of authorizing the use of the investigational new drug or drug unapproved for its
applied use, the Secretary of Health and Human Services may require to be disclosed.
(e) Records of Use. -
The Secretary of Defense shall ensure that the medical records of members accurately document -
(1)
the receipt by members of any investigational new drug or drug unapproved for its applied use; and
(2)
the notice required by subsection (a)(1).
(f) Limitation and Waiver. -
(1)
In the case of the administration of an investigational new drug or a drug unapproved for its applied use to a member of the
armed forces in connection with the member's participation in a particular military operation, the requirement that the
member provide prior consent to receive the drug in accordance with the prior consent requirement imposed under section
505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) may be waived only by the President. The
President may grant such a waiver only if the President determines, in writing, that obtaining consent -
(A)
is not feasible;
(B)
is contrary to the best interests of the member; or
(C)
is not in the interests of national security.
(2)
In making a determination to waive the prior consent requirement on a ground described in subparagraph (A) or (B) of
paragraph (1), the President shall apply the standards and criteria that are set forth in the relevant FDA regulations for a
waiver of the prior consent requirement on that ground.
(3)
The Secretary of Defense may request the President to waive the prior consent requirement with respect to the administration
of an investigational new drug or a drug unapproved for its applied use to a member of the armed forces in connection with
the member's participation in a particular military operation. With respect to any such administration -
(A)
the Secretary may not delegate to any other official the authority to request the President to waive the prior consent
requirement for the Department of Defense; and
(B)
if the President grants the requested waiver, the Secretary shall submit to the chairman and ranking minority member of each
congressional defense committee a notification of the waiver, together with the written determination of the President under
paragraph (1) and the Secretary's justification for the request or requirement under subsection (a) for the member to receive
the drug covered by the waiver.
(4)
In this subsection:
(A)
The term ''relevant FDA regulations'' means the regulations promulgated under section 505(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(i)).
(B)
The term ''prior consent requirement'' means the requirement included in the relevant FDA regulations pursuant to section
505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)).
(C)
The term ''congressional defense committee'' means each of the following:
(i) The Committee on Armed Services and the Committee on Appropriations of the Senate.
(ii)
The Committee on Armed Services and the Committee on Appropriations of the House of Representatives.
(g) Definitions. -
In this section:
(1)
The term ''investigational new drug'' means a drug covered by section 505(i) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(i)).
(2)
The term ''drug unapproved for its applied use'' means a drug administered for a use not described in the approved labeling
of the drug under section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355)
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Last revised: December 2003