View all text of Chapter 55 [§ 1071 - § 1110b]
§ 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 is not in the interests of national security.
(2) The waiver authority provided in paragraph (1) shall not be construed to apply to any case other than a case in which prior consent for administration of a particular drug is required by reason of a determination by the Secretary of Health and Human Services that such drug is subject to the investigational new drug requirements of section 505(i) of the Federal Food, Drug, and Cosmetic Act.
(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)).
(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).
(Added Pub. L. 105–85, div. A, title VII, § 766(a), Nov. 18, 1997, 111 Stat. 1827; amended Pub. L. 105–261, div. A, title VII, § 731(a)(1), (b), Oct. 17, 1998, 112 Stat. 2070, 2071; Pub. L. 106–65, div. A, title X, § 1067(1), Oct. 5, 1999, 113 Stat. 774; Pub. L. 108–136, div. A, title X, § 1043(b)(7), Nov. 24, 2003, 117 Stat. 1611; Pub. L. 108–375, div. A, title VII, § 726(a), Oct. 28, 2004, 118 Stat. 1992.)