§360bbb–6 Risk communication

Summary

The Secretary must create the Advisory Committee on Risk Communication to advise the FDA Commissioner on how to explain risks from products the FDA regulates. The committee must include experts on risk communication, experts on the drug safety issues 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 also work with medical societies, medical schools, academic medical centers, and other partners to build strong, multi‑way systems to tell health care providers about new safety problems that appear after drugs reach the market. These systems must account for differences among doctors (how they practice, their comfort with technology, and their specialties) and must use existing FDA communication channels, including electronic communications.