For Patients

About the FDA Patient Network

Subscribe Patient Network Newsletter Image

Subscribe to FDA's Patient Network Newsletter

Created in 2012, the FDA Patient Network (PN) is part of the Office of Health and Constituent Affairs (OHCA), formerly the Office of Special Health Issues (see the history of our office below). The FDA Patient Network is a comprehensive program that works to expand and sustain communication with patients and their community.  The FDA Patient Network also helps educate patients, patient advocates, and their healthcare professionals about medical product regulations and we continue to look at ways to involve patients more effectively in regulatory decisions related to medical product safety and approval.

OHCA continues to provide resources that help patients and consumers find the information they need to support their own health care, whether they want to learn more about clinical trials and where to find studies or when accessing investigational products outside of trials might be appropriate.

Through this Network, we have created an entire section for patients on FDA.GOV that addresses concerns patients and caregivers have about medications and provide answers to questions about the life-cycle of medical product development.

The FDA Patient Network is made up of:

  • patient specific pages on FDA.GOV that help you connect with the FDA through:

    • information about upcoming open public meetings.

    • opportunities to watch previously recorded webinars.

    • how to submit comments on FDA draft guidances or policy changes.

  • Patient Network News - a twice monthly newsletter that shares information about

    • new medical product approvals.

    • significant medication labeling changes.

    • new safety concerns on already approved medicines.

    • many other topics that are important to patients and patient advocates.

  • a Patient Network Meeting  that provide patients and their communities a way to learn more about the FDA process, previous topics have included:

    • May 2012 - FDA, Working with Patients to Explore Benefit/Risk: Opportunities and Challenges.

    • September 2013 – Demystifying FDA: An Exploration in Drug Development

    • September 2014 – Under the Microscope: Pediatric Product Development 

History

Learn why OHCA was established and how patient advocates became active participants in FDA decision-making

  • 1988

    FDA forms the Office of Special Health Issues to work with patient advocates, focusing mostly on the HIV/AIDS community.

  • Early 1990s

    Cancer patient advocates are recruited into the Patient Representative Program. The program expands to include patients and caregivers of serious and life-threatening diseases.

  • 1991

    The first Patient Representative serves on the Antiviral Drugs Advisory Committee for HIV.

  • 1996

    Patient Representatives receive voting privileges as members of FDA Advisory Committees and cast votes on therapies related to cancer.

  • 2001

    FDA expands the role of Patient Representatives to serve as consultants to medical product review divisions to gain the patient's view early in the medical product development process and provide patient advocates an opportunity to take part in FDA's decision making at meetings between FDA and product sponsors (developers).

  • 2006

    FDA forms the Health Professional Liaison Program to increase awareness of important risk and safety information among health professionals and to learn more about their concerns and viewpoints.

  • 2008

    FDA moves MedWatch to OHCA to encourage voluntary reporting of problems and side effects of marketed medical products from health professionals and patients.

  • 2012

    FDA created the Patient Network and currently has more than 200 Patient Representatives participating in the program.

Page Last Updated: 03/24/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.