FDA asks for advice on risk communications

Share this article:
Taking its lead from the IOM report, the FDA is establishing an advisory committee on risk communications. The committee will focus primarily on communications to the public, though it may also look at communication with physicians, said Crystal Rice of CDER media relations. It will consist of patient and consumer representatives, as well as people with expertise in risk communication, social marketing, health literacy and the social sciences generally. The agency aims to empanel the committee quickly, said Rice, and while not permanent, it will probably be a long-term endeavor. “Given the continuing importance of effective communication about regulated products, our initial thoughts are that this committee will continue to be useful over time,” said Rice. Other steps to improve drug safety announced by the agency include: a pilot program to assess the utility of postmarketing evaluation for routine new molecular entities; organizational and management changes to tighten communications between review and safety staff; more information sharing between FDA and the Veterans Health Administration; a CDER electronic safety tracking system; and an upgrade of the Adverse Events Reporting System database with new signal detection and tracking tools.
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in News

Five things for Pharma Marketers to know: Friday, August 29

Five things for Pharma Marketers to know: Friday, ...

Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.