Provisions addressing clinical trial diversity should be included in must-pass legislation
Every five years, Congress must reauthorize a law called the Prescription Drug User Fee Act (PDUFA), which allows the Food and Drug Administration (FDA) to collect fees from companies that produce certain drug and biological products. These fees help provide the resources needed to conduct timely reviews of new drug applications. The current PDUFA reauthorization ends on Sept. 30 and is considered "must-pass" legislation because user fees play an important role in funding FDA's operations. While there is no debate as to whether to pass the law, there is disagreement in Congress on what provisions to include.
In previous PDUFA reauthorizations, lawmakers have included provisions that address what the FDA can do beyond the user fees. Lawmakers are currently considering whether to include provisions that would help improve diversity in clinical trials. The House of Representatives passed their version of PDUFA reauthorization (H.R. 7667) on June 8, which includes these important clinical trial diversity provisions. Unfortunately, the Senate version (S. 4348) – which passed in the Senate Committee on Health, Education, Labor and Pensions (HELP) on June 14 – does not.
Increasing diversity in clinical trials is an important part of advancing health equity overall. A clinical trial is a research study that tests the effectiveness and safety of new treatments, medicines or therapies. Participants in clinical trials are key to that process and should represent the diverse group of people who have the health problem being studied – like kidney disease – and will use the treatment when approved.
While people from communities of color are disproportionately affected by kidney disease, unfortunately they are underrepresented in clinical trials. The elderly, people with low income and rural residents are also routinely underrepresented. To make sure that treatments are safe and work for all people with kidney disease, it is important for clinical trials to include people from diverse backgrounds.
As members of the House and Senate continue to work on PDUFA reauthorization, the American Kidney Fund (AKF) is advocating that the final bill include the provisions to increase clinical trial diversity that are in the House-passed bill. These provisions would:
- Require clinical trial sponsors (companies developing a new drug) to submit diversity action plans to the FDA that include enrollment and diversity goals for their clinical trials.
- Require the FDA to submit an annual report to Congress that summarizes information on the diversity action plans they have received and make the report available to the public.
- Require the FDA to issue guidance that addresses considerations for offering some clinical trial services at community health centers or at a participant's home rather than solely at academic medical centers, which are often harder for people in rural areas to access due to distance. The guidance would also consider utilizing digital health tools such as telemedicine to help increase diversity in clinical trials.
Additionally, AKF is advocating for adding a provision that provides resources for community-based providers to hire and train culturally competent on-site staff to conduct and recruit for trials. We are also urging lawmakers to include a provision that addresses financial barriers to clinical trial participation that people with low incomes may experience.
If you would like to help advocate for improved diversity in clinical trials, we encourage you to contact your members of Congress and urge them to include these provisions in final PDUFA reauthorization legislation.