Public Policy Resources

The Clinical Trial Modernization Act (H.R. 8412) would increase access to clinical trials by allowing clinical trial sponsors to provide financial support to patients for costs associated with their trial participation, including medical cost-sharing like copays, and non-medical expenses such as travel, parking, food and lodging.

ACS CAN submitted comments on draft U.S. Food and Drug Administration (FDA) guidance on Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for Food and Drug Administration-Regulated Medical Products.

Drug shortages have had a significant impact on cancer patients, causing difficult decisions that have included rationed drugs, reduced or skipped doses, and altered treatment regimens which can lead to less effective treatments.

In response to a request from the National Institute of Starndards and Technology (NIST), ACS CAN has offered comments on the use of march-in rights to address drug costs. 

In response to an annual request from the Department of Health and Human Services (HHS), ACS CAN has proposed a safe harbor from the Anti-Kickback Statute that would allow trial sponsors to provide financial support to trial participants to offset non-medical costs. 

FDA has proposed to end enforcement discretion with respect to regulating the performance of LDTs.  ACS CAN has long supported harmonizing and modernizing diagnostic oversight and supports the proposed rule.  

ACS CAN submitted comments to the U.S. Food and Drug Administration (FDA) on Medication Guides: Patient Medication Information Proposed Rule.

ACS CAN submitted comments to the U.S. Food and Drug Administration (FDA) on Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials Draft Guidance for Industry.