42 U.S.C. § 300cc–12 — Use of investigational new drugs with respect to acquired immune deficiency syndrome

(a) Encouragement of applications with respect to clinical trials: (1) If the Secretary decides there is early evidence that a new drug works in humans to prevent or treat AIDS, the Secretary must publish statements in the Federal Register that (A) announce this decision and (B) encourage someone to apply for permission to study the drug (an "investigational use" exemption under FDA rules in section 355(i) of title 21). (2)(A) The AIDS Research Advisory Committee, set up under section 300cc–3, must recommend to the Secretary which new drugs deserve this kind of determination. (B) The Secretary must decide, as quickly as practical, whether those recommendations have merit. (b) Encouragement of applications with respect to treatment use in circumstances other than clinical trials: (1) Once a drug has an (a) determination and an active investigational-use exemption, the Secretary must (A) encourage the drug's sponsor to apply, under the FDA's rules, to use the drug to treat people who are infected with the AIDS virus but who are not in the formal clinical trials, and (B) if that application is approved, encourage licensed doctors to get the drug from the sponsor to treat those patients. (2) If the sponsor does not submit that kind of application, the Secretary must instead use Federal Register notices to encourage licensed doctors themselves to apply directly. (c) Technical assistance with respect to treatment use: For any drug with an (a) determination, the Secretary may give technical help — directly, or by paying for it through grants or contracts — with (1) applying for the investigational-use exemption described in (a)(1)(B), (2) applying for treatment use described in (b), and (3) helping sponsors get the drug to licensed doctors. (d) "New drug" defined: In this section, "new drug" means whatever section 321 of title 21 says it means.