Washington, D.C. — Yesterday, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) released the much anticipated 21st Century Cures Act 2.0 (Cures 2.0).

This innovative and forward-thinking bipartisan legislation could safely and efficiently revolutionize the delivery of health care in our country.

“Diseases like cancer, Alzheimer’s, ALS, diabetes, and so many more don’t care if you’re a Republican or a Democrat. They affect us all the same,” said Representative Upton. “Our bipartisan 21st Century Cures 2.0 legislation will provide our nation’s top scientific minds with the resources they need to find the cures and treatments to devastating illnesses that impact every family. Renewing hope for patients and their families is a mission that truly unites us all.”

“It will make healthcare more accessible, it will make breakthrough therapies available to patients sooner, and it will help us better understand the effects of illnesses we don’t even know yet enough about, such as COVID,” said Representative DeGette.

The bill includes a provision that would provide a clear and consistent mechanism to fully incorporate patient experience data (PED), which addresses the psychosocial concerns, needs, and preferences of patients, into the drug development process. Specifically, this provision requires drug manufacturers and sponsors to collect and report on PED as part of a clinical trial in a meaningful, uniform way that is informative to both patients and providers. It also requires the Food and Drug Administration (FDA) to fully consider all PED collected during the clinical trial.

Dr. Elizabeth Franklin, President of the Cancer Support Community (CSC), the largest professionally led nonprofit network of cancer support worldwide, issued the following statement: 

“We applaud the inclusion of the PED provision in Cures 2.0 and commend Representatives DeGette and Upton for their steadfast commitment to incorporating the patient experience in drug development and throughout the research and care continuum.

Passage of the 21st Century Cures Act, as amended by the Food and Drug Reauthorization Act of 2017, recognized and elevated the importance of PED, which goes beyond the physical symptoms or side effects of a disease, therapy, or clinical investigation, to also address the psychosocial concerns, needs, and preferences of cancer patients.

Fully embracing PED in clinical trials advises patients, caregivers, providers, and trial sponsors about the investigation’s impact on the whole person — information that helps to inform each of the above-mentioned stakeholders whether on treatment decisions, care obligations, or trial design — now and in the future.

We were also pleased to see the inclusion of the Telehealth Modernization Act in Cures 2.0 The COVID-19 pandemic has highlighted the benefits of expanding telehealth access by removing Medicare’s geographic and originating site restrictions. Permanently securing these flexibilities beyond the public health emergency will ensure beneficiaries continue to receive access to services that improve their health and well-being.

We look forward to working with lawmakers to ensure that this bill quickly becomes law so that patients and caregivers’ experiences assume their rightful, intended, and integral role in the drug development process.”  

Learn more about the bill.

About the Cancer Support Community

As the largest professionally led nonprofit network of cancer support worldwide, the Cancer Support Community (CSC), including its Gilda’s Club affiliates, is dedicated to ensuring that all people impacted by cancer are empowered by knowledge, strengthened by action, and sustained by community. CSC achieves its mission through three areas: direct service delivery, research, and advocacy. The organization’s Institute for Excellence in Psychosocial Care includes an international network of affiliates that offer the highest quality social and emotional support for people impacted by cancer, as well as a community of support available online and over the phone. The Research and Training Institute conducts cutting-edge psychosocial, behavioral, and survivorship research. CSC furthers its focus on patient advocacy through its Cancer Policy Institute, informing public policy in Washington, D.C., and across the nation. For more information, please call the toll-free Cancer Support Helpline at 888-793-9355.