21 U.S.C. § 360bbb–6 — Risk communication
submitted 88 years ago by Pub. L. 110-85 to r/title-21-FOOD-AND-DRUGS · 201 words · no verdicts yet
This law requires the FDA to set up a permanent Advisory Committee on Risk Communication to advise on how to clearly explain product risks. It also requires the FDA to partner with medical groups to build better systems for warning doctors about newly discovered drug risks after a drug is on the market.
(a) Advisory Committee on Risk Communication
(1) In general. The Secretary* must create an advisory committee called the "Advisory Committee on Risk Communication."
(2) Duties of Committee. The Committee advises the FDA Commissioner* on how to effectively explain the risks of products the FDA regulates.
(3) Members. The Secretary must make sure the Committee includes risk-communication experts, experts on the specific risks covered in subsection (b), and representatives from patient, consumer, and health professional groups.
(4) Permanence of Committee. Federal advisory committees are normally subject to a periodic renewal requirement under section 1013 of title 5. That renewal rule does not apply to this Committee — it is permanent.
(b) Partnerships for risk communication
(1) In general. The Secretary must team up with professional medical societies, medical schools, academic medical centers, and other stakeholders to build strong, varied systems for telling health care providers about newly emerging drug* risks discovered after the drug is already on the market.
(2) Partnerships. Those systems must (A) take into account how differently physicians practice, how willing they are to adopt new technology, and their medical specialty, and (B) use the FDA's existing communication channels, including electronic ones.
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.
The systems developed under paragraph (1) shall—
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.
Source credit: (June 25, 1938, ch. 675, § 567, as added Pub. L. 110–85, title IX, § 917, Sept. 27, 2007, 121 Stat. 960; amended Pub. L. 117–286, § 4(a)(157), Dec. 27, 2022, 136 Stat. 4323.)
- 1938Enacted · Pub. L. 110-85 · 121 Stat. 960
- 2022Amended · Pub. L. 117-286 · 136 Stat. 4323
A history note hasn’t been published yet. The record shows enactment by Pub. L. 110-85 on 1938-06-25.
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