Public Policy Resources

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Administration (FDA) on Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials Draft Guidance for Industry.

Representation is important to cancer patients and survivors when it comes to the composition of clinical trials, with patients saying it is important that drugs are tested among patients who share their gender, age, and general health. Women consider it more important that drugs be tested in patients who share their gender than do men, while people of color are most concerned about representation in clinical trials.

ACS CAN submitted comments to the U.S. Food and Drug Administration (FDA) Draft Guidance on Decentralized Clinical Trials. 

These consensus recommendations endorsed by 12 organizations identify key steps to improve equitable pharmacogenomic (PGx) discovery and  implementation in oncology.

By focusing explicitly on bold, transformative, and applied research projects, ARPA-H holds the potential to quickly bridge the gap between the research lab and the patient.