Prescription Drug User Fee Act (PDUFA) reauthorization

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Congress is currently considering legislation reauthorizing the Prescription Drug User Fee Act (PDUFA) which authorizes the Food and Drug Administration (FDA) to collect fees from companies that produce certain drug and biological products. These fees help provide the necessary resources for the FDA to conduct timely reviews of new drug applications.

In the PDUFA that is currently being considered in Congress, lawmakers are considering whether to include provisions that would help improve diversity in clinical trials.

Increasing clinical trial diversity is an important element in advancing health equity. Clinical trial participants are key to developing safe treatments that work well to prevent, diagnose and treat kidney disease. The participants in clinical trials should represent the diverse group of people who have the health problem being studied and will use the treatment out in the world.

However, while people from communities of color are disproportionately affected by kidney disease, they are underrepresented in clinical trials. Additionally, the elderly, lower income individuals, and people from rural areas are routinely underrepresented in clinical trials. 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, a final bill needs to include provisions to increase clinical trial diversity. It should include the provisions that are in the House-passed bill, which would:

Require clinical trial sponsors (companies developing a new drug) to submit to the FDA diversity action plans that include enrollment and diversity goals for their clinical trials. Require the FDA to submit to Congress and make available to the public an annual report that summarizes information on the diversity action plans they have received. Require the FDA to issue guidance that addresses considerations for decentralized clinical trials. Clinical trials are typically conducted at academic medical centers, but centralizing clinical trial services can lead to the exclusion of people who cannot travel long distances to those centers. Decentralizing clinical trials so that some services can be conducted at community health centers or a participant's home and utilizing digital health tools such as telemedicine can help increase clinical trial diversity.

Additionally, a final PDUFA reauthorization bill should include provisions that provide resources for community-based providers to support the hiring and training of culturally competent on-site staff to conduct and recruit for trials.

It should also include a provision that addresses financial barriers to clinical trial participation that lower income people may experience.

Please contact your legislators to request they support the inclusion of these clinical trial diversity provisions in a final PDUFA reauthorization.