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Title 21, Food and DrugsRelease 119-73not60

§360bbb–6 Risk Communication

Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices › § 360bbb–6

Last updated Apr 5, 2026|Official source

Summary

The Secretary must create an Advisory Committee on Risk Communication (called the Committee). The Committee will help the FDA Commissioner find better ways to talk about risks from FDA-regulated products. It must include experts on risk communication, experts on the postmarket drug risks described below, and representatives of patient, consumer, and health professional groups. Section 1013 of title 5 does not apply to the Committee. The Secretary must work with medical societies, medical schools, academic medical centers, and other stakeholders to build strong systems to tell health care providers about new safety concerns that appear after drugs are on the market. Those systems must fit different kinds of doctors, different tech use, and specialties. They must use existing FDA ways to communicate, including electronic messages.

Full Legal Text

Title 21, §360bbb–6

Food and Drugs, Source: USLM XML via OLRC

(a)(1)The Secretary shall establish an advisory committee to be known as the “Advisory Committee on Risk Communication” (referred to in this section as the “Committee”).
(2)The Committee shall advise the Commissioner on methods to effectively communicate risks associated with the products regulated by the Food and Drug Administration.
(3)The Secretary shall ensure that the Committee is composed of experts on risk communication, experts on the risks described in subsection (b), and representatives of patient, consumer, and health professional organizations.
(4)Section 1013 of title 5 shall not apply to the Committee established under this subsection.
(b)(1)The Secretary shall partner with professional medical societies, medical schools, academic medical centers, and other stakeholders to develop robust and multi-faceted systems for communication to health care providers about emerging postmarket drug risks.
(2)The systems developed under paragraph (1) shall—
(A)account for the diversity among physicians in terms of practice, willingness to adopt technology, and medical specialty; and
(B)include the use of existing communication channels, including electronic communications, in place at the Food and Drug Administration.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Amendments

2022—Subsec. (a)(4). Pub. L. 117–286 substituted “Section 1013 of title 5” for “section 14 of the Federal Advisory Committee Act”.

Reference

Citations & Metadata

Citation

21 U.S.C. § 360bbb–6

Title 21, Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60