§360bbb–6 Risk Communication

Summary

Creates an Advisory Committee on Risk Communication that the Secretary must set up. The Committee must advise the Commissioner on how to explain risks from products the FDA regulates. Its members must include experts in risk communication, experts on the kinds of risks named below, and representatives of patient, consumer, and health professional groups. Section 1013 of title 5 does not apply to the Committee. The Secretary must also work with professional medical societies, medical schools, academic medical centers, and other stakeholders to build strong systems to tell health care providers about new drug safety problems after drugs are on the market. Those systems must fit different types of doctors, their comfort with technology, and specialties, and must use existing FDA communication channels, including electronic communications.