Regulating Off-Label Drug Promotion: A New Perspective

Open Access
Jacobs, Benjamin K
Area of Honors:
Health Policy and Administration
Bachelor of Science
Document Type:
Thesis Supervisors:
  • Karen Volmar, Thesis Supervisor
  • Pamela Farley Short, Honors Advisor
  • off-label drug use
  • FDA regulation
  • pharmaceutical marketing
For almost two decades, the FDA’s attempts to regulate off-label drug promotion have been a source of controversy among the agency, drug companies, and First Amendment advocates. Critics of the FDA say that regulation is both a First Amendment violation as well as an obstacle to patients receiving the best possible drug treatments. Advocates for regulation, however, warn that the consequences of allowing drug companies to freely promote off-label uses could be fatal. This paper analyzes the conflict from all angles and then proposes a recommendation that not only seeks to satisfy all parties involved but also allows for patients to receive the best possible drug therapies.