Report from the Field: Patient Involvement at the US Food and Drug Administration

In this new feature, we aim to highlight the innovative and patient-centered work of other organizations at the local, regional, and national level. This is part of an ongoing effort to develop a network of Patient Advisors who are informed and educated on research and healthcare issues. For this quarter, we wanted to highlight a national effort to ensure the patient voice is represented in regulatory decisions. Do you know of an organization or initiative we should highlight? Let us know!

The US Food and Drug Administration (FDA) involves patients and patient representatives to inform efforts to ensure human drug and biologic projects are safe and effective. There are two main efforts underway at the FDA where patients are actively involved, the FDA Patient Representative program and through a new initiative for Patient-Focused Drug Development.

Patient Representatives provide the FDA with the unique perspective of both patients and family members affected by a serious or life-threatening disease. FDA Patient Representatives participate on Advisory Committees and offer the patient perspective, providing comments to assist the committee in making recommendations. Patient Representatives may also consult for review divisions when a medical product or therapy is under review or present at FDA meetings and workshops on disease-specific or regulatory and health policy issues. To learn more about the FDA Patient Representative Program check out the FDA website.

ecognizing the importance of the patient voice and the opportunity to more effectively gather patient perspectives on their disease and available treatment options, the FDA launched the Patient-Focused Drug Development Program in 2013. This initiative comes through the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V), which committed the FDA to further develop the approach for assessing the benefits and risks associated with regulatory decision making. Over a five year period, the FDA will hold a public meeting on 20 different disease areas to collect patient perspectives. Meetings planned for 2014-2015 are listed in the table below. Patients are invited to attend public meetings either in person or through web conferencing. In addition to providing input at meetings, patients can provide input through public dockets. Interested in learning more or getting involved? Learn more about meeting updates and opportunities for participation at the FDA website.

Author: CERTAIN Patient Advisory Network

The CERTAIN Patient Advisory Network seeks to improve research by providing a way for patients to work in collaboration with researchers throughout the research process — from the identification of research questions to the communication of the results.

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