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AAMC Submits Comments on FDA’s Draft Patient-Focused Drug Development Guidance

September 14, 2018—The AAMC submitted a Sept. 11 letter to the Food and Drug Administration (FDA) in response to a request for comments on the draft guidance, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.

The AAMC supported the FDA’s collection and use of “patient experience data” to inform the agency’s regulatory decisions and commended the FDA in its solicitation of feedback on the tools and methods related to the collection and use of these data. To help the agency further these efforts, the AAMC emphasized the importance of the FDA ensuring that patients, caregivers, and families are engaged meaningfully throughout development and implementation phases of the research process. The association strongly recommended that “the FDA work with patients and other key stakeholders to develop a framework for using patient engagement data during the study design phase to help define the research objectives and questions.”

The AAMC underscored the importance of ensuring the final guidance will be useful for all stakeholders interested in collecting and submitting patient data to the FDA, including lay patients or individuals who may be unfamiliar with the research methodologies and processes included in the guidance.

The AAMC also encouraged the FDA to develop strategies to ensure the engagement of a diverse representation of patient and advocate populations. The association said that the recently established FDA Office of Patient Affairs should “play a key role in the internal coordination of the data submitted to the Agency in addition to serving as a central point for industry, patients, and other stakeholders.”

In its June 2017 response to the FDA’s proposal for the future of patient engagement, the AAMC expressed strong support for the agency’s current and proposed patient engagement efforts, which included the establishment of an Office of Patient Affairs [see Washington Highlights, June 16, 2017].

Contact:

Philip M. Alberti, PhD
Senior Director, Health Equity Research and Policy
Telephone: 202-828-0522
Email: palberti@aamc.org

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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.


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For More Information

Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org