NCCS Joins Colleagues in Offering Comments on an Alternative Approval Pathway

NCCS joined its colleagues in the patient advocate and cancer care provider community in offering comments to the Food and Drug Administration (FDA) on an alternative approval pathway for drugs to treat certain diseases where there is an unmet medical need.  FDA requested public comment on a proposal that was developed by the President’s Council of Advisors on Science and Technology, or PCAST.  NCCS and others in the Cancer Leadership Council urged caution in embracing any new approval pathway and stressed that any pathway for review and approval must provide assurances that the approved drug was tested in a robust clinical trial or trials that produced data supporting the drug’s efficacy and safety.  As cancer patients make difficult treatment decisions, they must have assurance related to the safety and effectiveness of the drugs they take.