Medical Device Link.

NEWS TRENDS

FDA announced in June that it is forming an advisory committee to counsel the agency on how best to communicate risks and benefits of FDA-regulated products to the public.

Improving risk-benefit communication has been a goal of CDRH’s Postmarket Transformation Initiative and other agency postmarket efforts. Too often, product risks are discussed in the media without any perspective about their benefits, noted the agency in a news release. Yet, direct-to-­consumer advertisements of medical dev­ices and drugs sometimes draw criticism for ­emphasizing benefits too much over risks.

The committee aims to help the agency better understand what the general public wants in terms of communication about devices and other products. It will advise FDA on developing strategic plans to communicate product risks and benefits. It will inform FDA about the latest research on these matters. And it will recommend how to best communicate specific product information to “vulnerable audiences.”

The idea came from a 2006 Institute of Medicine report, which recommended such a panel for communication about drugs. FDA decided to expand its scope to include all regulated products.

The panel will include 15 voting members, divided between experts on subjects like risk communication and social marketing and stakeholders such as patients and caregivers. Information about making nominations to the committee can be found at www.fda.gov/OHRMS/DOCKETS/98fr/oc07124.pdf.