42 U.S.C. § 300cc–14 — Evaluation of certain treatments

(a) Establishment of program: (1) After consulting the AIDS Research Advisory Committee set up under section 300cc–3, the Secretary must create a program to evaluate drugs that (A) the FDA has not approved for treating AIDS, but that (B) people infected with the AIDS virus are using anyway to treat it. (2) This program must evaluate both how effective these unapproved treatments are and how risky they are, including the risk of skipping FDA-approved treatments instead. (b) Authority with respect to grants and contracts: (1) To run the evaluations described in (a), the Secretary may give grants to, and sign cooperative agreements and contracts with, public agencies and nonprofit private groups. (2) Those nonprofit groups can include ones that (A) exist specifically to evaluate AIDS treatments and (B) are made up mostly of people infected with the AIDS virus. (c) Scientific and ethical guidelines: (1) The Secretary must write appropriate scientific and ethical guidelines for how these evaluations are run. The Secretary cannot give money under (b)(1) unless the applicant agrees to follow these guidelines. (2) The Secretary can only write these guidelines after consulting three groups: (A) doctors whose practice includes a significant number of AIDS patients, (B) people who are themselves infected with the AIDS virus, and (C) other people with relevant expertise or experience. (d) Authorization of appropriations: Congress could appropriate whatever money was needed to carry out this section.