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AAMC Submits Comments on FDA Report

September 13, 2013—The AAMC submitted a Sept. 5 letter  to the Food and Drug Administration (FDA) in response to a report outlining the FDA’s communication plan to better inform and educate health care providers and their patients, particularly patients from underrepresented populations, on the benefits and risks of medical products. The request for comment was published in the July 11 Federal Register.

In its report, the FDA outlined the recommendations of an internal, agency-wide workgroup convened to strategize around traditional and electronic communication efforts.  Specific opportunities identified by the working group included targeting outreach to traditionally underserved subpopulations and increasing their representation in the FDA Patient Network; addressing the needs of limited English proficiency populations; and leveraging the communication power of social media. 

Given that differential access to medical information and knowledge is one mechanism that creates and maintains racial/ethnic and socioeconomic disparities in health and health care, the AAMC commended FDA’s efforts to ensure universally equitable access to current safety information about medical products and devices.  In addition to supporting the strategies identified by the FDA internal working group, the AAMC encouraged the agency to engage communities and conduct qualitative research to understand how various underrepresented subpopulations prefer to receive medical and health information, informing efforts  to craft effective, population-specific communication strategies.

The AAMC also suggested that while social media and electronic communication are crucial to increase diffusion of medical information, certain populations such as the elderly and rural populations often have limited access to the internet and social media sites.  Care should be taken to ensure that a focus on electronic communication does not inadvertently exacerbate rural/urban and age-based health care disparities.

The FDA report and public comment period were required by the Food and Drug Administration Safety and Innovation Act (FDASIA, P.L. 112-144), which requires that the FDA address its communication strategy for safety alerts and related patient and provider action, information about subpopulation identification, and any planned communication enhancements including electronic communication strategies.


Philip M. Alberti, PhD
Senior Director, Health Equity Research and Policy
Telephone: 202-828-0522

Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926


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