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AAMC Submits Letter to FDA on Public Health Concerns of Demographic Subgroups

April 24, 2015—The AAMC April 16 submitted a letter  to the Food and Drug Administration (FDA) regarding areas of public health concern for racial/ethnic minority populations to enhance development of the FDA’s research agenda and inform funding decisions for the next fiscal year.  The request for comment was published in the Federal Register on Feb. 25, 2015.

In the letter, AAMC supports the FDA’s efforts to seek more knowledge about the health of racial/ethnic demographic subgroups to better inform health care decisions of providers and patients.

Acknowledging the existing initiatives of the FDA, the AAMC provides suggestions to the FDA in three broad categories: 

  • Identifying areas of public health concern for racial/ethnic minorities;

  • Improving participation rates of racial and ethnic minorities in research; and

  • Effectively disseminating important information to all populations. 

The AAMC recommends the FDA leverage community health needs assessment (CHNA) data to identify prioritized health needs, develop strategies for communicating clinical trial results to participants, and create new methods to communicate FDA actions to all populations.

Furthermore, the AAMC encourages the FDA to broaden its current efforts to include other populations such as veterans, persons with disabilities, and LGBT and rural populations who also experience disparate health outcomes.


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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