FDA BRIEF: Week of January 9, 2016

FDA Encourages More Participation, Diversity in Clinical Trials

FDA relies on data from clinical these trials to safety and effectiveness of medical products. Participation low for certain populations: age >75, certain racial and ethnic groups

Diversity important

• Full picture of the risk/benefit
• Certain populations can be more at risk for certain diseases
• Differences in response among diverse groups
• Information in product labeling to help treatment decisions

FDA initiatives to encourage diversity

• Dedicated section on its website for patients
•  Initiative by Office of Women’s Health
• Minorities in Clinical Trials webpage  for Public Service Announcements
• 2017 FDA Guidance on collection of race and ethnicity data should be collected
• clinicaltrials.gov to search for studies to participate
•  Clinical Trials: What Patients Need to Know webpage

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FDA-Patented Invention Earns 2016 Patents for Humanity Award for Impact on Global Public Health

By: Carolyn A. Wilson, Ph.D., Associate Director for Research, CBER & Alice Welch, Ph.D., Director, Technology Transfer Program

• Dr. Robert Lee and Dr. Carl E. Frasch, enabled the production of inexpensive and highly effective vaccine, earning 2016 Patents for Humanity Award from the U.S. Patent and Trademark Office.
• In 2003, the CBER scientists  developed a pivotal step in manufacture of MenAfriVac vaccine
• Vaccine  has since protected > 235 million lives against recurring meningitis outbreaks in sub-Saharan Africa
• By 2020 the vaccine is expected to have protected > 400 million people, preventing 100 million cases of meningitis A, 150,000 deaths, and 250,000 cases of severe disability

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Martin Luther King and the Journey Towards Health Equity

“Of all the forms of inequality, injustice in health is the most shocking and the most inhuman because it often results in physical death.”

• Minority communities and lower rungs socio-economically remain disproportionately burdened by chronic disease
• FDA Office of Minority Health (OMH) dedicated to strengthening FDA’s ability to respond to minority health concerns

Let’s create a world where health equity is a reality for all. 

www.FDA.gov/MinorityHealth / @FDAOMH

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