Section 1137: Patient Participation in Medical Product Discussions
Update: On February 19, 2016- The Food and Drug Administration Safety and Innovation Act (FDASIA)Section 1137: Patient Participation in Medical Product Discussions Report on Stakeholder Views published in the Federal Register Notice
FDA has long involved patients and considered patient perspectives in its work. Recent activities aim to expand and better integrate the role of patient perspectives in regulatory decision-making over the total product life cycle.
On July 9, 2012 the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144). FDASIA expands the Food and Drug Administration’s (FDA or Agency) authorities and strengthens the Agency's ability to safeguard and advance public health in numerous ways, including by:
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Giving the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs, and biosimilar biological products;
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Promoting innovation to speed patient access to safe and effective products;
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Increasing stakeholder involvement in FDA processes; and
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Enhancing the safety of the drug supply chain.
Section 1137 of FDASIA, Patient Participation in Medical Product Discussions, directs the Secretary of Health and Human Services to: develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions, including:
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Fostering participation of a patient representative who may serve as a special government employee in appropriate Agency meetings with medical product sponsors and investigators; and,
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Exploring means to provide for identification of Patient Representatives who do not have any, or have minimal, financial interest in the medical products industry.
Section 1137 strengthens FDA’s ability to safeguard and advance public health for patients in the Agency’s activities. The statute recognizes the value of patient input by facilitating increased involvement of patients earlier in the regulatory process for medical product review.
To plan for the implementation of FDASIA Section 1137 and summarize FDA’s current program functions that address patient participation, FDA formed a work group in the Spring 2013 to discuss current programs and activities and consider strategies across the Agency for building upon current patient participation in accordance with the statute. The group was comprised of representatives from FDA Centers responsible for human medical product regulation and the Office of the Commissioner. Members include:
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Center for Biologics Evaluation and Research (CBER)
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Center for Devices and Radiological Health (CDRH)
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Center for Drug Evaluation and Research (CDER)
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Office of the Commissioner (OC)
The work group identified current activities ongoing within their Center/Office as well as future plans for developing patient engagement activities. Beyond this, the work group sought input from the public and on December 4, 2014, FDA issued a Federal Register (FR) notice establishing a docket (FDA-2014-N-1698) for public commenters to submit information related to FDA’s implementation of FDASIA’s Patient Participation in Medical Product Discussions under FDASIA section 1137. The FR Notice announced FDA’s intent to gather input from stakeholders on strategies to obtain the views of patients during the medical product development process and to identify ways to consider patients’ perspectives during regulatory discussions.