FDA regulation & drug policy

FDA oversight of drug approvals, drug scheduling, pharmaceutical tariffs, medical device regulation, and drug safety enforcement.

Overview

FDA regulation and drug policy encompasses federal oversight of pharmaceutical approvals, drug scheduling decisions, import tariffs on medicines, and safety enforcement actions. The Trump administration pursued sweeping changes including 100% tariffs on imported drugs, reclassification of medical marijuana as Schedule III, and efforts to end animal testing requirements for drug safety research.

Multiple former FDA officials described a mass exodus following administration cuts, while the agency moved to close the GRAS loophole allowing food additives without federal notification. The FDA also faced pressure on vaccine policy, with the HHS secretary demanding drug companies split combined vaccines.