FDA To Factor Public Health Effects, Other Therapies Into Opioid Reviews

FDA will take into account a proposed opioid’s broader public health effects, including on non-users, and look at how the product compares in safety and effectiveness to already-approved analgesics when making future approval decisions, the agency revealed in a draft guidance published Thursday (June 20). The process tracks with recommendations former FDA Commissioner Scott Gottlieb made in the months before he left the agency. Gottlieb signaled that FDA, using new authorities under the SUPPORT for Patients and Communities Act, would...