FDA proposes a ‘modest’ change to a rule for policing off-label marketing

Christel Deskins

After years of controversy, the Food and Drug Administration has issued a proposed rule to clarify when manufacturers would have to update product labeling to reflect unapproved uses of their medicines. In doing so, the agency has left intact a decades-old rule that stated drug makers must update labeling if […]

After years of controversy, the Food and Drug Administration has issued a proposed rule to clarify when manufacturers would have to update product labeling to reflect unapproved uses of their medicines.

In doing so, the agency has left intact a decades-old rule that stated drug makers must update labeling if there is evidence indicating a company intended its medicine to be used off-label, or for an unapproved use. Doctors are free to prescribe a medicine for any purpose, but court rulings have determined drug makers can make statements about off-label uses only if information provided is truthful and not misleading.

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