FDA Communications Report Open for Public Comment
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.
The report was requested under Section 1138 of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, which asked FDA to address:
- The best strategy for communicating safety alerts, labeled indications for medical products, changes to the label or labeling of medical products (including black box warnings, health advisories, health and safety benefits and risks), and the particular actions to be taken by health care practitioners and patients.
- Any information identifying particular subpopulations.
- Any other relevant information as determined appropriate to enhance communication; including varied means of electronic communication, and;
- A process for implementation of any improvements or other modifications determined to be necessary.
FDA has opened a docket to seek public comment on the report’s findings and FDA’s communication plans going forward.
HOW TO SUBMIT COMMENTS:
Please submit electronic or written comments by September 9, 2013.
The Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
All comments should be identified with the docket number [Docket No. FDA-2013-N-0757]
This report was developed to fulfill the requirements of Section 1138 and is posted on FDA's Office of Minority Health Web site.
For further information contact: Jonca Bull, 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: firstname.lastname@example.org.
For more information:
- FDASIA Sec. 1138: Communication Report with Special Attention to Underrepresented Subpopulations
- Food and Drug Administration Safety and Innovation Act (FDASIA)
- HHS Action Plan to Reduce Racial and Ethnic Health Disparities
- The U.S. Department of Health and Human Services Language Access Plan 2013
- FDA Plain Language
- National Standards on Culturally and Linguistically Appropriate Services (CLAS)
- LEP.gov - Limited English Proficiency (LEP): A Federal Interagency Website
- Think Cultural: Advancing Health Equity at Every Point of Contact
- HRSA: Health Literacy
- FDA: Minority Health
- Tips for submitting comments