Unpublished Paper
After Caronia: First Amendment Concerns in Off-Label Promotion
ExpressO (2013)
  • Stephanie Greene , Boston College Law School
Abstract
After Caronia: First Amendment Concerns in Off-Label Promotion by Stephanie M. Greene* Abstract The government has successfully prosecuted pharmaceutical companies for off-label promotion of drugs, maintaining that such promotion impermissibly undermines the FDA’s pre-market approval process and jeopardizes the public health. In several recent cases, however, pharmaceutical companies have alleged that regulations prohibiting such promotion are unconstitutional because off-label promotion is protected under the First Amendment. Two recent Supreme Court cases contain language that gives broad protection to advertising and marketing in the pharmaceutical field. This paper questions the reach of these cases as applied to the practice of off-label promotion through detailing.
Keywords
  • First Amendment,
  • off-label promotion,
  • FDA regulation
Publication Date
August 30, 2013
Citation Information
Stephanie Greene. "After Caronia: First Amendment Concerns in Off-Label Promotion" ExpressO (2013)
Available at: http://works.bepress.com/stephanie_greene/1/