In a fit of anger, drug makers are urging the Food and Drug Administration to delay a final rule giving the agency greater leeway to police off-label marketing over concerns it would harm public health by “chilling valuable scientific speech,” according to a recently filed petition.
The rule, which was issued last month, says drug makers must update product 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 drugs for any purpose, while court rulings determined drug companies can make statements about off-label uses only if the information provided is truthful and not misleading.
At issue is a concept known as intended use, which the FDA relies upon for determining when a company intentionally markets a drug for an unapproved use. Two years ago, the agency issued a proposed rule that deleted language indicating a company could be liable for having knowledge of unapproved uses. The move followed years of concern by drug makers over the threat of prosecution.