2011 US Code
Title 21 - Food and Drugs
Chapter 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT (§§ 301 - 399d)
Subchapter V - DRUGS AND DEVICES (§§ 351 - 360ccc-2)
Part E - General Provisions Relating to Drugs and Devices (§§ 360bbb - 360bbb-6)
Section 360bbb-6 - Risk communication

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”).

The Committee shall advise the Commissioner on methods to effectively communicate risks associated with the products regulated by the Food and Drug Administration.

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.

Section 14 of the Federal Advisory Committee Act shall not apply to the Committee established under this subsection.

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.

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.

(June 25, 1938, ch. 675, §567, as added Pub. L. 110–85, title IX, §917, Sept. 27, 2007, 121 Stat. 960.)

Section 14 of the Federal Advisory Committee Act, referred to in subsec. (a)(4), is section 14 of Pub. L. 92–463, which is set out in the Appendix to Title 5, Government Organization and Employees.