At the Food and Drug Administration (FDA), essential to our mission in public health protection is to determine if medical products, such as medications and devices, are safe and effective for the patients likely to need them. Sometimes demographic subgroups – women, racial and ethnic minorities, the elderly – may respond differently to some medical products, so we must advance our understanding of health disparities and the development of treatments that work better for them.
That’s why it was important that in 2010, FDA’s Office of Minority Health (FDA OMH) was established by the Affordable Care Act to advise FDA on ways to reduce health disparities among racial and ethnic subgroups. The creation of this office was one of the many milestones that have served as a driving force to advance health equity since the Report of the Secretary’s Task Force on Black and Minority Health (also known as the Heckler Report), which was the first time the U.S. government convened a group of experts to conduct a comprehensive study of the health status of minorities.
We believe it is critical to advancing health equity to have more demographic subgroups participate in clinical trials. More diverse study participants will increase the knowledge base FDA reviewers draw on to determine if medical products are “safe and effective” (the legal standard for approving a product) for these groups. This information will also allow consumers and their medical providers to make the best, most informed decisions on which medical products will garner the best health outcome.
Historically, racial and ethnic minorities and women have been underrepresented in clinical trials. To remedy this situation, FDA is working with patient advocates and industry to raise awareness among minority patients of opportunities to participate in clinical trials and to include more providers who care for diverse patients in the design of clinical trials.
Last year, FDA took steps to protect and promote minority health by releasing the Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data. It has 27 action items addressing three priorities:
- Quality: to improve the completeness and quality of demographic subgroup data;
- Participation: to identify barriers to subgroup enrollment in clinical trials and employ strategies to encourage greater participation; and
- Transparency: to improve the public availability of demographic subgroup data.
These action items aim to improve the quality of data collected, and the transparency and availability of easily understood data from clinical trials. We have implemented several activities and initiatives since the action plan’s release. Some of these include:
- Drug Trials Snapshots Website: FDA’s Center for Drug Evaluation and Research (CDER) recently launched the first transparency initiative, a website to display drug trials snapshots. The snapshots outline clinical trials participation by sex, race and age in an easy-to-read format. Simply put, transparency initiatives like this website allow consumers who are researching a treatment to see how someone like them performed on a medicine.
- Efforts to Improve Best Practices: FDA is working with Industry to establish best practices and ways to help ensure appropriate use of enrollment criteria in clinical trial protocols.
- Efforts to Modify Data Collection Forms: FDA has proposed changes to the MedWatch adverse event reporting forms to enhance the clarity and utility of the demographic information FDA is able to collect in the post-market setting. These include collecting data about race/ethnicity and age.
At FDA, we are proud of our progress to date – but we can always do more to advance public health and reduce health disparities. We plan to hold a public meeting in 2016, 18 months after the Action Plan’s release. Your insight and feedback on the Action Plan’s progress are vital to its success.
Sign up for our newsletter to stay informed about upcoming meetings and other topics of interest. For more information about FDA OMH, visit our website at www.fda.gov/minorityhealth and follow us on Twitter at @FDAOMH.
Jonca Bull, MD is the Director of the Food and Drug Administration Office of Minority Health.