10 U.S.C. § 1107 — Notice of use of an investigational new drug or a drug unapproved for its applied use

(a) Notice required. (1) When the Secretary of Defense asks or requires a service member to receive an “investigational new drug” or a “drug unapproved for its applied use,” the Secretary must give the member a notice containing the information in subsection (d). This section defines those terms in subsection (g). (2) The Secretary must also make sure that health care providers who give such a drug, or who are likely to treat members who receive one, get the information required by paragraphs (3) and (4) of subsection (d). (b) Time of notice. The member must receive the notice before the drug is first given to the member. (c) Form of notice. The notice must be in writing. (d) Content of notice. The notice must include: (1) a clear statement that the drug is an “investigational new drug” or a “drug unapproved for its applied use”; (2) the reasons the drug is being given; (3) information about possible side effects, including known side effects that could result from the drug interacting with other drugs or treatments being given to members who receive it; and (4) any other information that the Secretary of Health and Human Services may require to be disclosed as a condition of allowing use of the drug. (e) Records of use. The Secretary of Defense must make sure members’ medical records accurately document (1) that a member received either kind of drug, and (2) the notice required by subsection (a)(1). (f) Limitation and waiver. (1) If such a drug is given to a service member because the member is taking part in a particular military operation, only the President may waive the requirement that the member give prior consent under section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)). The President may grant the waiver only after deciding in writing that getting consent is not in the interests of national security. (2) This waiver power applies only when prior consent for a particular drug is required because the Secretary of Health and Human Services decided that the drug is subject to the investigational-new-drug requirements of section 505(i) of that Act. (3) The Secretary of Defense may ask the President to waive that prior-consent requirement for a member taking part in a particular military operation. (A) The Secretary may not give another official the authority to make that request for the Department of Defense. (B) If the President grants the request, the Secretary must notify the chairman and ranking minority member of each congressional defense committee. The notice must include the President’s written determination under paragraph (1) and the Secretary’s reasons for asking or requiring under subsection (a) that the member receive the drug covered by the waiver. (4) In this subsection: (A) “Relevant FDA regulations” means regulations issued under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)). (B) “Prior consent requirement” means the requirement in those regulations under section 505(i)(4) of that Act. (g) Definitions. In this section: (1) “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) “Drug unapproved for its applied use” means a drug given for a use not described in the drug’s approved labeling under section 505 of that Act (21 U.S.C. 355).