21 U.S.C. § 387r: Drug products used to treat…

Summary

The Secretary must, if an applicant asks, consider giving smoking‑cessation products (including nicotine replacement like patches, gum, and lozenges) fast‑track review under section 356. The Secretary must also consider allowing longer use of nicotine replacement to treat tobacco dependence and must review evidence for other uses, such as easing cravings or preventing relapse. No later than 3 years after June 22, 2009, the Secretary must send Congress a report, after consulting scientific and public‑health experts and relevant agencies, on how best to regulate, promote, and encourage new nicotine and non‑nicotine products and treatments to help people quit, cut down, and reduce harm. The report must include recommendations on how the FDA should share and coordinate information with its offices and with NIH, CDC, and other agencies.

Title 21, §387r

Food and Drugs, Source: USLM XML via OLRC

(a)In general

The Secretary shall—

(1)at the request of the applicant, consider designating products for smoking cessation, including nicotine replacement products as fast track research and approval products within the meaning of section 356 of this title;

(2)consider approving the extended use of nicotine replacement products (such as nicotine patches, nicotine gum, and nicotine lozenges) for the treatment of tobacco dependence; and

(3)review and consider the evidence for additional indications for nicotine replacement products, such as for craving relief or relapse prevention.

(b)Report on innovative products

(1)In general

Not later than 3 years after June 22, 2009, the Secretary, after consultation with recognized scientific, medical, and public health experts (including both Federal agencies and nongovernmental entities, the Institute of Medicine of the National Academy of Sciences, and the Society for Research on Nicotine and Tobacco), shall submit to the Congress a report that examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine-based products and treatments) to better achieve, in a manner that best protects and promotes the public health—

(A)total abstinence from tobacco use;

(B)reductions in consumption of tobacco; and

(C)reductions in the harm associated with continued tobacco use.

(2)Recommendations

The report under paragraph (1) shall include the recommendations of the Secretary on how the Food and Drug Administration should coordinate and facilitate the exchange of information on such innovative products and treatments among relevant offices and centers within the Administration and within the National Institutes of Health, the Centers for Disease Control and Prevention, and other relevant agencies.

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Modification of Deadlines for Secretarial ActionWith respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

§387r Drug Products Used to Treat Tobacco Dependence

Summary

Title 21, §387r

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Citations & Metadata