Food and Drug Administration

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

FDA looks to patient advocates and public representatives to contribute their perspectives on issues and to evaluate indications for oncology drugs.

Cancer Liaison Program

Housed in FDA’s the Office of Special Health Issues, the Cancer Liaison Program is a contact point for the cancer community. The staff assists advocates serving on FDA committees, advisory groups, and programs as well as answers questions from the public about therapies for life-threatening diseases.

Patient Consultant Program

The Patient Consultant Program incorporates patient advocates into the drug development and review process prior to FDA ruling. Patient Consultants offer views on clinical trial design, trial endpoints, expanded access protocol development, and patient recruitment strategies. Patient consultants may also sit on the Oncologic Drugs Advisory Committee (ODAC) with full voting rights.

Cancer Patient Representative Program

Cancer patient representatives serve on advisory committees in the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH). These representatives also have voting privileges in ODAC.

For more information on advocacy opportunities at the FDA, visit the FDA’s Cancer Liaison Program web site.