Federal · Title 21 — Food and Drugs

21 U.S.C. § 360bbb: Risk communication

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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 1013 of title 5 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. account for the diversity among physicians in terms of practice, willingness to adopt technology, and medical specialty; and include the use of existing communication channels, including electronic communications, in place at the Food and Drug Administration.

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