STAT Plus: Could FDA use off-label data for drug approvals? It’s possible, agency official says
WASHINGTON — The Food and Drug Administration might one day use data gathered from off-label uses of drugs to determine whether or not to approve the drugs for those uses, an agency division director said Tuesday.
The FDA approves drugs for specific conditions in certain groups of people and then spells out those prescribed uses on a drug’s label. But physicians can prescribe the drugs to anyone for anything, so-called off label.