 National Minority Health Month
Save the Date: Strategies to Increase Clinical Trial Participation for Diverse Communities, A Panel Discussion with the OMHHE REACH Consortium
April 17, 11 a.m. ET, Virtual
Every April, the FDA Office of Minority Health and Health Equity (OMHHE) observes National Minority Health Month (NMHM) to raise awareness of the importance of improving the health of racial and ethnic minority populations and reducing health disparities. During this virtual event, members of the Racial and Ethnic Minority Acceleration Consortium for Health Equity (REACH), representing organizations and researchers working in diverse communities throughout the nation, will discuss their ongoing work with REACH to improve clinical trial participation among racial and ethnic minority, rural, urban, and other communities they serve.
News At FDA
FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects
The FDA is warning consumers not to use certain over-the-counter analgesic (pain relief) products that are marketed for topical use to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing. The agency issued warning letters to six companies for marketing these products in violation of federal law.
FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy
The FDA approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD.
FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy
The FDA approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD).
FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease
The FDA approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), to be used along with diet and exercise.
FDA Seeks $7.2 Billion to Enhance Food Safety and Nutrition, Advance Medical Product Safety, and Strengthen Public Health
This funding will allow the agency to enhance food safety and nutrition, advance medical product safety, help support supply chain resiliency, strengthen the agency’s public-health and mission-support capacity, and modernize the FDA’s infrastructure and facilities.
FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight
The FDA approved a new indication for use for Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight.
FDA Takes Steps to Ensure Safety of Cinnamon Products Sold in the US
The FDA is taking several additional steps to address concerns about elevated lead levels in cinnamon following the recent incident associated with certain cinnamon apple sauce pouches that resulted in lead poisoning in young children.
Voices in Health Equity
Harnessing the Potential of Artificial Intelligence
By: Robert M. Califf, M.D., Commissioner of Food and Drugs
The FDA has been working for years to anticipate and prepare for the challenges of Artificial Intelligence (AI), and to harness its potential.
Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together
This paper outlines specific focus areas regarding the development and use of AI across the medical product lifecycle.
Q&A with FDA Podcast: The Current Status of Oral Phenylephrine as a Nasal Decongestant with Dr. Theresa Michele and Dr. Ilisa Bernstein
This episode discusses the FDA’s advisory committee meeting on oral phenylephrine as a nasal decongestant.
Upcoming Events
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access
April 10 - 11, 8:30 a.m. - 5:00 p.m. ET both days, Virtual and In-person
The Generic Drugs Forum is an annual, two-day event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the pre-ANDA program and ANDA assessment program.
Cardiovascular Disease Disparities in Rural America: Can This House of Cards Be Saved?
April 17, 2:00 p.m. - 3:00 p.m. ET, Virtual
Join the NIH Office of Intramural Research for this lecture on cardiovascular disease disparities in the rural U.S. This lecture will feature Debra Moser Ph.D., RN, FAHA, FAAN, Assistant Dean of Ph.D. Program & Scholarly Affairs & Linda C. Gill Professor in Nursing at the University of Kentucky College of Nursing.
Understanding the Biological Mechanisms Underlying the Health Consequences of Racism, Marginalization, and Discrimination
April 17, 10:00 a.m. - 4:50 p.m. ET; April 18, 8:45 a.m. - 4:00 p.m. ET; Virtual and In-person
This virtual and in-person event will convene people from diverse populations living with or at risk for diabetes and digestive and kidney diseases and conditions, as well as researchers and clinicians from across disciplines, to understand the state of the science and identify opportunities for considering common biological pathways underlying the consequences of racism, marginalization, and discrimination across population groups and disease areas.
Opportunities
Fellowship in Genomic Science and Health Equity
The National Institutes of Health’s (NIH) National Human Genome Research Institute (NHGRI) and the Food and Drug Administration’s (FDA) Office of Minority Health and Health Equity (OMHHE) are cosponsoring a fellowship. The fellow is expected to start in summer 2024.
Applications are being accepted and will be screened on a rolling basis until the position is filled.
In Case You Missed It
Keep Your Home Safe – Dispose of Expired Medicine
Spring cleaning? Don’t forget to clean out your medicine cabinet. Learn how to safely dispose of expired and unused medicines today!
Taking Z-drugs for Insomnia? Know the Risks
Prescription Z-drugs work by slowing activity in the brain. Used properly, they can help you sleep. Quality sleep can have a positive impact on physical and mental health. But the treatments also carry the risk – though rare – of serious injuries, and even death. Be aware of these risks.
Resources For You
OMHHE offers many easy-to-use and culturally-appropriate resources on minority health, health disparities, and related topics. These resources are available to view online, print, or share. Some are available in Spanish and additional languages.
Visit www.fda.gov/HealthEquityResources for more information.
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