Message from the Associate Commissioner
Dear Women’s Health Colleagues,
Today, the U.S. Food and Drug Administration (FDA) issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product.
Diversity Action Plans must specify the sponsor’s rationale and goals for clinical study enrollment (separated by the age, group, sex, and racial and ethnic demographic characteristics of clinically relevant study populations) and describe how the sponsor intends to meet those goals. The guidance also encourages sponsors to consider additional factors relating to the representativeness and enrollment of the clinical trial population that extend beyond age, sex, ethnicity, and race to enroll populations. For example, a sponsor developing a Diversity Action Plan should also consider the potential that pregnant or lactating individuals with the condition or disease may use the medical product. This draft guidance highlights FDA’s commitment toward enhancing a representative clinical trial population.
In addition to collaborating on the development of this guidance, OWH actively advocates for the inclusion of women in clinical trials. Representation of women in clinical trials is an important focus area for our office. OWH’s Diverse Women in Clinical Trials Initiative raises awareness about clinical trial participation by women of all ages, races, and ethnicities, various chronic health conditions, and disabilities. Through the Diverse Women in Clinical Trials Initiative, OWH strengthens the agency’s commitment to promoting and advocating for inclusion and diversity in clinical trials.
Please take a moment to learn more about the FDA Guidance on Diversity Action Plans. Comments on the draft guidance should be submitted within 90 days after publication in the Federal Register to Regulations.gov.
Sincerely,
Kaveeta P. Vasisht, M.D., Pharm.D.
Associate Commissioner for Women’s Health
Director, Office of Women’s Health (OWH)
  This year, National HIV Testing Day is observed on June 27. We encourage you to know more about your HIV status and encourage the women in your family and community to get tested. The theme for 2024, “Level up your self-love: check your status” emphasizes valuing yourself, showing yourself compassion and respect, and honoring your health needs with self-love. Knowing your HIV status helps you choose options to stay healthy.
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In recognition of Alzheimer’s and Brain Awareness Month, the FDA Office of Women’s Health (OWH) encourages you to learn more about clinical trials and how they can help health care researchers better understand the brain and this disease. Visit the Diverse Women in Clinical Trials Initiative at www.fda.gov/womeninclinicaltrials for resources to help you and the women in your community get the facts about clinical trials.
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