Patient group crafting guidance on patient engagement

On Wednesday, the non-profit National Health Council released an outline of proposed FDA guidance on the integration of patient perspectives into drug development and regulation. The group, which advocates for patients with chronic conditions, said it will submit the guidance to FDA by July.

The guidance would commit FDA to "publicly express its support for meaningful patient engagement across the product lifecycle," but would not make patient engagement a requirement for product approval, according to a summary of meetings the NHC and the Genetic Alliance held with FDA, patient groups, drug developers and other stakeholders. The guidance "should also state that the FDA expects meaningful patient engagement to be the norm," and would encourage "early and frequent communication" with FDA to discuss patient engagement. ...