Dozens of patient groups urge congress to reauthorize Prescription Drug User Fee Act.
Eighty-seven organizations representing patients with chronic and acute health conditions, sent a letter to Congress on May 11, urging them to improve the diversity of enrollment in clinical trials as part of this year’s Prescription Drug User Fee Act (PDUFA) reauthorization. Reauthorizing PDUFA would allow the Food and Drug Administration (FDA) to continue its vital mission of reviewing and approving drugs. Unless Congress takes action, the current authorization is set to expire on Sept. 30, 2022.
In addition to providing FDA with authority to collect user fees from drug sponsors to conduct its mission, the bipartisan legislation includes a provision of the Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, bipartisan, bicameral legislation that would increase access to clinical trials and improve clinical trial diversity. The provision would require the FDA to issue guidance on the use of decentralized trial practices like telemedicine, which could allow greater participation of underrepresented groups in clinical trials.
“While most cancer patients express a willingness to participate in clinical research, only a small fraction ultimately end up enrolling in a cancer clinical trial due to barriers that make participation difficult or even impossible.” said Lisa Lacasse, president of the American Cancer Society Cancer Action Network (ACS CAN), which organized the group letter in partnership with the Leukemia and Lymphoma Society. “This provision would benefit both patients and research by improving access to lifesaving clinical trials, ensuring that trial participants are more socioeconomically, geographically, and racially diverse, and accelerating the development of new and better treatment options for patients.”
“Greater diversity in clinical trials is a true ‘win win,’” said Katie Berge, director of federal affairs for The Leukemia & Lymphoma Society. “It means more individuals will have access to the latest treatments. And it means the data underpinning medical innovation will be better and more reliable. Millions may benefit from these reforms.”
While the groups applauded the inclusion of this and other provisions to improve clinical trial diversity, including requiring sponsors to submit diversity plans to FDA at the start of drug development and requiring the FDA to submit annual reports on clinical trial diversity, they also urged Congress do more to help reduce financial barriers to clinical trial participation and improve outreach to underserved patients.
“Removing financial barriers to clinical trial enrollment and improving outreach to traditionally underrepresented groups will increase participation and are crucial to our efforts to reduce the cancer burden,” said Lacasse. “Reauthorizing PDUFA would help remove these barriers and enable the FDA to continue its vital work uninterrupted, ensuring that cancer patients have timely access to the newest therapies. We thank the leadership of the U.S. House Energy and Commerce Committee and urge Congress to quickly pass this bill.”
ACS CAN will be participating in a session on the persistent need for diversity in clinical trials at the Congressional Hispanic Caucus Institute Annual Health Summit next week on May 18.