The prevalence of chronic diseases and conditions is still significantly higher among racial and ethnic minorities; in 2013, minorities continue to live sicker and die younger. Many of us in the research community work each day to find answers to why these disparities persist. Compounding a number of social, environmental and economic challenges, public health historically has not done a good job of including members of minority groups in important research, or advancing knowledge that provides the possible clinical reasons for health disparities.
A key provision of the Affordable Care Act, Section 4302, was designed to strengthen federal data collection and establish standards for collecting and reporting data on race, ethnicity, sex, primary language and disability status. It aims to help researchers, policy makers, health providers and advocates identify, monitor and address health disparities to improve treatment and quality of life.
In my role at FDA and in my previous work as a physician, I have always been committed to addressing health disparities as a dimension of improving the entire health care system. ACA 4302 is an important provision that can have a positive impact on research design and help advance our understanding of health care disparities.
Our mission at FDA is to protect and promote the public's health, serving as both a consumer protection agency and a regulatory agency. We are responsible for ensuring that medical products – drugs, biologics and devices – are safe and effective for their intended use. This includes providing guidance to manufacturers and the review of clinical trial data to ensure that the population included in clinical studies for an investigational product adequately represents the patients likely to be prescribed the product by health care providers. It is critical that careful attention is given to demographic subgroups and health disparities so that the information gathered and analyzed is representative of patients likely to use the product and can be available to inform prescribing decisions if differences are found.
Additionally, FDA provides guidance to product sponsors on diverse representation in research so that any important differences are identified, which may impact safe and effective use. FDA has provided such guidance – Collection of Race and Ethnicity Data in Clinical Trials [PDF | 67KB] – to help medical product sponsors understand and implement current recommendations.
Today, we have an incredible opportunity to move closer to our goal of eliminating racial and ethnic health disparities. What we in the research community must also do is think differently about how we approach inclusion to ensure that racial and ethnic minorities are adequately represented in research at all levels.
To learn more about Minority Health Month and the Affordable Care Act, visit http://minorityhealth.hhs.gov and http://www.healthcare.gov, and join in the conversation @MinorityHealth and @HealthCareGov.
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Jonca Bull, MD, is the first permanent director of FDA's Office of Minority Health. After 12 years in various roles at FDA, she left to work in the private sector and serves as an assistant clinical professor at George Washington University—a post she still holds. She returned to FDA to direct the Office of Minority Health in August 2012.