Integrating the Patient into the Drug Development Process: Developing FDA Guidance

Many stakeholders in the health care community have expressed a need for the U.S. Food and Drug Administration (FDA or the Agency) to provide guidance to encourage product sponsors (e.g., biopharmaceutical companies) to engage patients throughout the drug research and development lifecycle, illustrate how this can be achieved, and ensure the information collected is useful to the regulatory review process. Patients, researchers, and product sponsors alike welcome formal guidance from the FDA on how patients can be appropriately and meaningfully engaged.

To move this effort forward, the National Health Council (NHC) and Genetic Alliance (GA) convened a December 9, 2015, meeting with 36 multi-stakeholder participants. The objective of the meeting was to inform the scope and contents of a proposed FDA guidance document intended to guide industry, patient organizations, and other stakeholders in collecting input and information from patients to help inform drug research, development, regulatory review, and post-marketing activities, spanning the entire product lifecycle. 

The report summarizes key themes and priorities arising from the stakeholder discussions, includes an outline for an initial draft FDA guidance document, and lists additional topics that stakeholders identified as important, but were not prioritized for the initial guidance document. To read the paper in its entirety, click here