DEI Special Edition Spring / Summer 2024
The Past, Present, and Future Beyond FDA Mandates
by Barry Holmes, Jr.
In August 2010, the FDA introduced the Affordable Care Act, which established its Office of Minority Health with the goal of reducing health disparities among racial and ethnic minorities. Then in 2012, Congress passed the FDA Safety and Innovation Act, which directed the FDA to examine racial and ethnic subgroup data in applications for drugs, biologics, and medical devices and to publish its findings. In 2014, FDA issued an Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data, prioritizing the improvement of completeness and quality of demographic subgroup data, the identification of barriers to subgroup enrollment in clinical trials and development of strategies to encourage participation, and an increase in availability and transparency of subgroup data. Since then the FDA has issued a number of guidance docu- ments furthering these efforts, including the most recent DEPICT Act, and the Reform Act. They demanded an increase in diversity in clinical trials by requir- ing enhanced data reporting on clinical trial participant demographics and providing resources to underrepresented communities to improve access and participation in clinical trials. As well as requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA) which was passed into law February 21, 2024.
Understanding the “ gap ” that exists be - tween HCP ’ s and patients is the first step in understanding the past and present history of the industry, and what is truly needed to be successful in the
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