The AAMC June 12 submitted a letter to the Food and Drug Administration (FDA) in response to FDA’s March 14 request for comments on the agency’s efforts “to enhance future patient engagement by providing a more transparent, accessible, and robust experience for patient communities.” The agency identifies several objectives for its patient engagement activities and requests specific feedback on whether it should establish a new Office of Patient Affairs to achieve its objectives.
The AAMC letter recognizes the FDA’s current efforts to engage patients in the regulatory process and the development of new drugs, biologics, and devices. The letter also supports the FDA’s efforts to establish an Office of Patient Affairs. Among other recommendations, the AAMC encourages the FDA to increase patient input and recommends that the FDA take the following steps to enhance its engagement activities:
- Engage a broad and diverse community of patients, their families, and patient advocates;
- Take measures to ensure patient advocates and representatives engaged in FDA’s activities are not solely selected, trained or funded by industry;
- Solicit input on reliable ways to generate, standardize, and integrate patient-reported data into the regulatory process; and
- Regularly solicit public feedback on the agency’s patient engagement efforts.
The AAMC also highlights its September 5, 2013 comment letter on ensuring access to information about medical products with a focus on patients from traditionally underrepresented and underserved subpopulations.