USA – FDA Draft Guidance for Waivers of REMS Requirement Draws Mixed Reactions

A recent US Food and Drug Administration (FDA) draft guidance on a requirement under the Risk Evaluation and Mitigation Strategy (REMS) program for pharmaceutical sponsors was met with mixed reactions from a Rutgers law professor and Novartis in new comments.

The draft guidance that set the stage for how sponsors’ requests for waivers of the single, shared system (SSS) requirement would be evaluated by FDA was issued earlier this year, along with a separate guidance newly drafted for the development of a REMS for multiple prescription drugs.

Stakeholders have until 30 August to comment on both draft guidances, which seek to mitigate potential abuse of REMS requirements and support greater access to generics drugs in the US. Still, the law professor expressed support for the proposed draft policies, whereas Novartis called for changes to factors FDA intends to consider for waivers of the SSS requirement…