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.
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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
Office of Health and Constituent Affairs Timeline
FDA forms the Office of Health and Constituent Affairs to work with patient advocates, focusing mostly on the HIV/AIDS community.
In 1991, the first FDA Patient Representative serves on the Antiviral Drugs Advisory Committee for HIV. The office expands the patient communities they are working with to include cancer and other special health issues. Patient with serious and life-threatening diseases are recruited into the FDA Patient Representative Program. FDA Patient Representatives receive voting privileges as members of FDA Advisory Committees in 1996 and they are able to cast votes on therapies related to cancer.
FDA expands the role of the FDA 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).
2006FDA 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.
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).
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.
FDA moves MedWatch to OHCA to encourage voluntary reporting of problems and side effects of marketed medical products from health professionals and patients.
FDA created the Patient Network and currently has more than 200 Patient Representatives participating in the program.
FDA forms the FDA-EMA (European Medical Agency) Patient Engagement Cluster and along with CTTI (Clinical Trials Transformation Initiative) a Patient Engagement Collaborative.