42 U.S.C. § 285o–4: Medication Development…

Summary

Create a Medication Development Program inside the Institute. The Institute Director must meet regularly with the Commissioner of Food and Drugs to talk about ways to speed or improve approval of drug-abuse treatments. The Director must promote and fund research, trials, experiments, and international collaboration on medicines to treat drug addiction. The Director must help set up research facilities, report on related work by other agencies, and collect, study, and share useful data and research results nationally and internationally. The Director must support training in basic science and clinical work tied to these medicines, using grants, stipends, fellowships, and awards when needed. The Director must coordinate activities with the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Mental Health, and other appropriate Institutes and consult their directors. The Director must publish information, make grants and contracts, may build or maintain research centers and equipment and may accept voluntary services, gifts, or donations. The Director must keep channels open for sharing scientific information with national and international groups. The Director must send a report to the Office of National Drug Control Policy by December 31, 1992, and each December 31 after that. The National Drug Control Policy Director must include each report in the National Drug Control Strategy submitted the following February 1. Pharmacotherapeutics means medicines used to treat drug abuse, including drugs that block abused drugs’ effects, reduce craving, ease withdrawal, reverse toxic effects, or help prevent relapse.

Title 42, §285o–4

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

(a)Establishment

There is established in the Institute a Medication Development Program through which the Director of such Institute shall—

(1)conduct periodic meetings with the Commissioner of Food and Drugs to discuss measures that may facilitate the approval process of drug abuse treatments;

(2)encourage and promote (through grants, contracts, international collaboration, or otherwise) expanded research programs, investigations, experiments, community trials, and studies, into the development and use of medications to treat drug addiction;

(3)establish or provide for the establishment of research facilities;

(4)report on the activities of other relevant agencies relating to the development and use of pharmacotherapeutic treatments for drug addiction;

(5)collect, analyze, and disseminate data useful in the development and use of pharmacotherapeutic treatments for drug addiction and collect, catalog, analyze, and disseminate through international channels, the results of such research;

(6)directly or through grants, contracts, or cooperative agreements, support training in the fundamental sciences and clinical disciplines related to the pharmacotherapeutic treatment of drug abuse, including the use of training stipends, fellowships, and awards where appropriate; and

(7)coordinate the activities conducted under this section with related activities conducted within the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Mental Health, and other appropriate institutes and shall consult with the Directors of such Institutes.

(b)Duties

In carrying out the activities described in subsection (a), the Director of the Institute—

(1)shall collect and disseminate through publications and other appropriate means, information pertaining to the research and other activities under this section;

(2)shall make grants to or enter into contracts and cooperative agreements with individuals and public and private entities to further the goals of the program;

(3)may, in accordance with section 289e of this title, and in consultation with the National Advisory Council on Drug Abuse, acquire, construct, improve, repair, operate, and maintain pharmacotherapeutic research centers, laboratories, and other necessary facilities and equipment, and such other real or personal property as the Director determines necessary, and may, in consultation with such Advisory Council, make grants for the construction or renovation of facilities to carry out the purposes of this section;

(4)may accept voluntary and uncompensated services;

(5)may accept gifts, or donations of services, money, or property, real, personal, or mixed, tangible or intangible; and

(6)shall take necessary action to ensure that all channels for the dissemination and exchange of scientific knowledge and information are maintained between the Institute and the other scientific, medical, and biomedical disciplines and organizations nationally and internationally.

(c)Report

(1)In general

Not later than December 31, 1992, and each December 31 thereafter, the Director of the Institute shall submit to the Office of National Drug Control Policy established under section 1501 of title 21 a report, in accordance with paragraph (3), that describes the objectives and activities of the program assisted under this section.

(2)National Drug Control Strategy

The Director of National Drug Control Policy shall incorporate, by reference or otherwise, each report submitted under this subsection in the National Drug Control Strategy submitted the following February 1 under section 1504 1 of title 21.

(d)“Pharmacotherapeutics” defined

For purposes of this section, the term “pharmacotherapeutics” means medications used to treat the symptoms and disease of drug abuse, including medications to—

(1)block the effects of abused drugs;

(2)reduce the craving for abused drugs;

(3)moderate or eliminate withdrawal symptoms;

(4)block or reverse the toxic effect of abused drugs; or

(5)prevent relapse in persons who have been detoxified from drugs of abuse.

Notes & Related Subsidiaries

Editorial Notes

References in Text

section 1501 and 1504 of title 21, referred to in subsec. (c), were repealed by Pub. L. 100–690, title I, § 1009, Nov. 18, 1988, 102 Stat. 4188.

Amendments

2007—Subsec. (e). Pub. L. 109–482 struck out heading and text of subsec. (e). Text read as follows: “For the purpose of carrying out this section, there are authorized to be appropriated $85,000,000 for fiscal year 1993, and $95,000,000 for fiscal year 1994.” 1993—Subsec. (b)(6). Pub. L. 103–43 substituted “Institute” for “Administration”.

Statutory Notes and Related Subsidiaries

Effective Date

of 2007 AmendmentAmendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.

Effective Date

Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as an

Effective Date

of 1992 Amendment note under section 236 of this title. Report by Institute on Medicine Pub. L. 102–321, title VII, § 701,

July 10, 1992, 106 Stat. 436, directed Secretary of Health and Human Services to enter into a contract with a public or nonprofit private entity to conduct a study concerning (1) role of the private sector in development of anti-addiction medications, including legislative proposals designed to encourage private sector development of such medications, (2) process by which anti-addiction medications receive marketing approval from Food and Drug Administration, including an assessment of feasibility of expediting marketing approval process in a manner consistent with maintaining safety and effectiveness of such medications, (3) with respect to pharmacotherapeutic treatments for drug addiction (A) recommendations with respect to a national strategy for developing such treatments and improvements in such strategy, (B) state of the scientific knowledge concerning such treatments, and (C) assessment of progress toward development of safe, effective pharmacological treatments for drug addiction, and (4) other related information determined appropriate by the authors of the study, and to submit to Congress a report of the results of such study not later than 18 months after

July 10, 1992.

§285o–4 Medication Development Program

Summary

Title 42, §285o–4

Notes & Related Subsidiaries

Editorial Notes

References in Text

Amendments

Statutory Notes and Related Subsidiaries

Effective Date

Effective Date

Effective Date

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