New FDA Advisory Committee Will Address Risk Communication to the Public

June 7, 2007
Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology

Rockville, MD (June 4)-Americans may soon have access to more information about the risks and benefits of the prescription and over-the-counter drugs they take. The US Food and Drug Administration is establishing an advisory committee to counsel the agency on how to strengthen the communication of risks and benefits of FDA-regulated products to the public.

Rockville, MD (June 4)-Americans may soon have access to more information about the risks and benefits of the prescription and over-the-counter drugs they take. The US Food and Drug Administration is establishing an advisory committee to counsel the agency on how to strengthen the communication of risks and benefits of FDA-regulated products to the public.

This type of communication is “essential to help consumers and healthcare professionals make informed decisions,” said Randall Lutter, FDA’s acting deputy commissioner for policy, in an agency press release. “The Risk Communication Advisory Committee will bring together a broad range of experts and views to help improve FDA’s communication of the science-based information about product risks and benefits that the public needs to make informed decisions.”

Specifically, the new advisory committee will:

  • Help FDA better understand the communication needs and priorities of the general public

  • Advise FDA on the development of strategic plans to communicate product risks and benefits

  • Make recommendations to FDA on what current research suggests about crafting risk and benefit messages as well as how to most effectively communicate specific product information to vulnerable audiences

The committee will be made up of 15 non-affiliated FDA members, including experts and authorities with backgrounds in risk communication, social marketing, health literacy, cultural competency, journalism, bioethics, and other relevant behavioral and social sciences, according to the FDA release. A few public citizens will be placed on the committee as well to provide the perspectives of consumers, patients, caregivers, and health professionals using FDA-regulated products.

The Institute of Medicine (Washington, DC) urged the formation of the committee in its 2006 report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, where it recommended that Congress enact legislation establishing a new advisory committee on how FDA communicates information about the efficacy, safety, and use of drugs and medical products. FDA took up the suggestion and also expanded the original concept of the committee to cover communication about all FDA-regulated product risks and benefits.

A Federal Register notice regarding nominations for members to serve on the committee will be published soon. Nominations received on or before 45 days after the Federal Register publication will be given first consideration.