Congress recently passed and the president signed into law legislation reauthorizing the Prescription Drug User Fee Act (PDUFA) which allows the Food and Drug Administration (FDA) to collect fees from companies that produce drug and biological products. These fees provide resources for the FDA to conduct timely reviews of new drug applications.
The PDUFA bill does not include provisions that would improve diversity in clinical trials. But Congress is considering including this provision in a year-end omnibus bill that would fund the government for the rest of the fiscal year.
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.
As members of the House and Senate continue to work on year-end omnibus legislation, a final bill needs to include provisions to increase clinical trial diversity. It should include the provisions that :
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 an annual report that summarizes information on the diversity action plans they have received. Require the FDA to issue guidance for 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. Provide resources for community-based providers to support the hiring and training of on-site staff to conduct and recruit for trials. 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 year-end omnibus legislation.