Off-Label Drug Communication Restrictions To Be Discussed At FDA Meetings
Pharmaceutical companies want regulators to loosen strict limits currently in place on what information they can provide to doctors about unapproved uses of prescription medications.
FDA To Hold Long-Awaited Meeting To Review 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. (Silverman, 8/31)
FDA To Hold Hearing On Updating Pharmaceutical Industry Speech Regulation
The Food and Drug Administration on Wednesday announced in the Federal Register that the agency will hold a public hearing in November to gather input about how companies communicate about their products. Specifically, the agency will focus on how companies discuss off-label uses of their products, the notice says. The FDA regulates how drug and device makers communicate about their products through approved labels, but many of those companies say there’s more information about their products worth sharing to help providers and others provide better care to patients. (McIntire, 8/31)