Call for Comments – FDA Plan for Communicating Medication Risks and Benefits

The U.S. Food and Drug Administration has issued a report on how the agency communicates
the benefits and risks of medical products to health care providers and patients, especially
underrepresented populations, including racial subgroups. The report also discusses some of the
steps FDA is taking to improve communications with underrepresented populations including the
development of a foreign language action plan and expanding the agency’s outreach to the minority
community through new communication channels such as social media. FDA opened a docket on July 11, 2013 for 60 days to solicit input from all relevant stakeholders regarding the communication plan. Section 1138 of FDASIA also requires FDA to publicly post the communication plan on the Internet Web site of the Office of Minority Health. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be posted to
the docket at Click Here under Docket Number FDA-2013-N-0757. Comments can also be viewed
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please
submit electronic or written comments by September 9, 2013.
For more information contact: Jonca Bull, M.D., Director, Office of Minority Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4274, Silver Spring, MD 20993-0002, 301-796-8000, email: jonca.bull@fda.hhs.gov.
http://www.fda.gov/ForConsumers/ByAudience/MinorityHealth/default.htm