I’m pleased to be with you today to help kick of this meeting addressing one of the most important areas of focus at the FDA – how we incorporate the patient voice in support of the development of new products to treat disease. 

Throughout today’s meeting, you’ll be discussing this topic and you’ll hear shortly from Jeff Shuren and others in CDRH about their engagement in this area and some of the important work they are doing related to the issue of health equity., 

So, I thought I would use my time this morning to briefly discuss some of the ways the FDA as a whole is committed to better understand and advance diverse patient perspectives, preferences and unmet needs to inform our work.

One of the most important aspects of our mission to protect and promote public health involves the responsibility to consider, to the extent we can, the needs and characteristics of all people and populations in the policies we advance, the science we support, and the workplace in which we operate. 

The issue of equity in public health is increasingly relevant, as many of the negative health trends we see today, from shortened life expectancy to increase in chronic diseases – diabetes and metabolic syndrome, heart, vascular, lung and kidney disease; mental health issues, as well as depression and suicide, drug use disorder, and gun violence – are the result in part of social determinants and inequities.  

Some of this disparity reflects the enormous differences we see in the U.S. as a function of demographics -- race, ethnicity, sex, gender, wealth and education.  One of the biggest impacts involves where we live.  As wealth, education and access to health and medical expertise are increasingly urbanized, people in rural settings in general are seeing a dramatic decline in health and life expectancy.   

So, it’s increasingly important that we study and consider these factors and prioritize them throughout our scientific work, ranging from access to clinical trials to the availability and consideration of user interface in the development of medical products and devices.  

It’s an issue with special resonance as we search for responses to new diseases like COVID, in which the impact on certain segments of the population, including older adults, pregnant women, children, rural people and racial and ethnic minorities, have been more severe. 

Consequently, one especially important area for us has been to work to increase the enrollment of minority, women, and elderly patients in clinical trials and bringing the voice of under-represented populations to the world of drug development. 

Of course, the FDA can’t do it alone. That’s why we are engaged in multiple collaborative efforts across the health care ecosystem.  For instance, we issued a call to action for stakeholders that outlines a number of steps they can take to help reduce gaps in health equity.  These  include:

•    Create a more diverse, equitable and geographically representative system of evidence generation for decision-making.
•    Revamp the public health information architecture to enable people to see data relevant to their own communities and circumstances.
•    Close the gap in knowledge between the evidence requirement for FDA approval, which can involve limited populations chosen to develop initial evidence of a positive balance of risks and benefits, and the appropriate use of products and payments in the real world, where the boundaries and relevant populations are much less clear.
•    Reduce the barriers that prevent aggregation of available information in a way that supports consortia driven by patients, as well as their families, caretakers and clinicians, while assuring that privacy and confidentiality are maintained.
•    Encourage health entities to consciously create incentives that reduce sub-optimization—a situation in which each segment of our system—hospitals, clinicians, medical products companies, insurance entities, now even private equity firms—is incentivized to optimize its own well-being without consideration of the joint effect on the system as a whole or the overall health of consumers and patients.  Part of this overall effort that is pertinent to FDA is to improve assessment of the impact of subsystems on overall health outcomes, for individuals and populations, as medical products have different outcomes in different healthcare ecosystems.
•    And finally, tackling misinformation and improve education about science.

Within the FDA itself, we’ve been working collaboratively across our medical product Centers to implement the Diversity Action Plan provisions of FDORA, our most recent user fee agreement.  This will help increase participation in clinical trials by diverse populations and allow the FDA to strengthen and expand communications about clinical trial demographics and representative populations so that consumers can make more informed decisions that lead to better health outcomes.  

Additionally, it is the mission of the FDA’s Office of Minority Health and Health Equity (OMHHE) specifically to promote and protect the health of diverse populations through research and communication of science that addresses health disparities and advances health equity.  In 2021, OMHHE established the Enhance Equity Initiative, which has provided multiple funding opportunities that have allowed us to engage with diverse researchers and scientists across various organizations and academic institutions.  In particular, they have focused on supporting activities in three areas: 

•    Increasing equity in clinical trials by continuing our efforts to advance diversity in clinical trial enrollment,
•    Strengthening the application of equitable data by funding research that helps us increase data available on the populations we serve, and
•    Increasing the equity of voices that focus on continuing to understand diverse patient perspectives, preferences and unmet needs to inform our work.

By working both inside the FDA and with our external stakeholders across the healthcare ecosystem, we are making important strides to expand health equity and better understand and advance diverse patient perspectives, preferences and unmet needs.

I hope your discussions on these issues today are engaging and productive, and I look forward to our continued collaboration in this important area.

Thank you.