42 U.S.C. § 300cc–14: Evaluation of certain…

Summary

The Secretary must create a program, after talking with the AIDS Research Advisory Committee, to study drugs that the FDA has not approved for treating AIDS but that people with the virus are using. The program must check how well those drugs work and what risks they have, including risks from not using FDA‑approved AIDS treatments. The Secretary can give grants or make contracts with public and nonprofit groups, including groups formed to test AIDS treatments and mostly made up of infected people. Projects must follow scientific and ethical guidelines the Secretary sets after consulting doctors who treat many AIDS patients, infected people, and other experts. Funds can be provided as needed.

Title 42, §300cc–14

The Public Health and Welfare, Source: USLM XML via OLRC

(a)Establishment of program

(1)After consultation with the AIDS Research Advisory Committee established pursuant to section 300cc–3 of this title, the Secretary shall establish a program for the evaluation of drugs that—

(A)are not approved by the Commissioner of Food and Drugs for the purpose of treatments with respect to acquired immune deficiency syndrome; and

(B)are being utilized for such purpose by individuals infected with the etiologic agent for such syndrome.

(2)The program established under paragraph (1) shall include evaluations of the effectiveness and the risks of the treatment involved, including the risks of foregoing treatments with respect to acquired immune deficiency syndrome that are approved by the Commissioner of Food and Drugs.

(b)Authority with respect to grants and contracts

(1)For the purpose of conducting evaluations required in subsection (a), the Secretary may make grants to, and enter into cooperative agreements and contracts with, public and nonprofit private entities.

(2)Nonprofit private entities under paragraph (1) may include nonprofit private organizations that—

(A)are established for the purpose of evaluating treatments with respect to acquired immune deficiency syndrome; and

(B)consist primarily of individuals infected with the etiologic agent for such syndrome.

(c)Scientific and ethical guidelines

(1)The Secretary shall establish appropriate scientific and ethical guidelines for the conduct of evaluations carried out pursuant to this section. The Secretary may not provide financial assistance under subsection (b)(1) unless the applicant for such assistance agrees to comply with such guidelines.

(2)The Secretary may establish the guidelines described in paragraph (1) only after consulting with—

(A)physicians whose clinical practice includes a significant number of individuals with acquired immune deficiency syndrome;

(B)individuals who are infected with the etiologic agent for such syndrome; and

(C)other individuals with appropriate expertise or experience.

(d)Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary.

Notes & Related Subsidiaries

Editorial Notes

Prior Provisions

A prior section 300cc–14, act July 1, 1944, § 2315, was successively renumbered by subsequent acts and transferred, see section 238l of this title.

Amendments

1993—Subsec. (a)(1). Pub. L. 103–43 substituted “AIDS Research Advisory Committee” for “Clinical Research Review Committee” in introductory provisions.

§300cc–14 Evaluation of Certain Treatments