FDA to Hold Long-Awaited Meeting on Off-Label Marketing

After years of anticipation, the US Food and Drug Administration will hold a public, two-day meeting in November to review the extent to which so-called off-label information about medicines may be disseminated to physicians.

Off-label information is regulatory parlance for materials that describe unapproved uses of a drug. Doctors are, in fact, allowed to prescribe a medicine for an unapproved use, but drug makers have long chafed at restrictions on their ability to distribute such information — reprints of medical studies, for example — and have lobbied Congress and the FDA to loosen regulations.