• Off-Label Use: Protected Commercial Speech or Misbranding?
  • August 17, 2016 | Author: David W. Ohlwein
  • Law Firm: Butler Snow LLP - Nashville Office
  • For years, the Food and Drug Administration has recognized that there is a prevalence of off-label use of drugs approved by FDA for specific indications, there is clinical relevance and value from such off-label use, and there is a large amount of information about both on- and off-label uses of such drugs available even with a limited ability by manufacturers to disseminate this information. This recognition requires a balancing by FDA between enforcing the Food, Drug, and Cosmetic Act’s regulations prohibiting promotion of off-label use and permitting dissemination of off-label information to healthcare professionals for use in treating their patients. Key to this balancing act is FDA’s position that any off-label discussions by manufacturers constitutes “misbranding” and are in violation of FDCA. Recent success by manufacturers establishing that disclosure of truthful and non-misleading information about off-label use of their products is protected commercial speech has thrown the FDA’s balance out of whack. While currently limited in scope, such challenges may change the FDA’s enforcement actions to focus more on false and misleading content in such off-label discussions and less on a presumption of “misbranding” based solely on the fact of off-label discussions.