Trade Groups Urge FDA to Re-examine Off-Label Standards

Industry trade group giants, PhRMA and BIO are nudging FDA to re-examine how it regulates off-label communication between drugmakers, health-care providers and payers.

PhRMA and BIO jointly published a set of principles covering what they believe drugmakers should and should not be allowed to share with doctors, insurance companies and pharmacy benefit managers. The FDA’s rules governing off-label information exchanges — which are intended to limit off-label promotion — are frequently challenged by industry on First Amendment grounds.