FDA's authority to prevent or even regulate off-label promotion by pharmaceutical companies is dwindling. After losing to Amarin in court, FDA suffered another setback when it settled a case with Pacira Pharmaceuticals. In both cases, the plaintiffs argued that off-label marketing was protected free speech as long as the information was truthful and not misleading. While the FDA still insists it has the ultimate authority to decide what is and is not truthful, other entities have claimed a stake in the debate.
This article summarizes various scenarios for how the FDA, courts, and independent 3rd-parties may influence off-label drug promotion in the future.
Topics (partial list)
Download the full article (PDF file) here:
- Avoiding Off-Label Chaos
- External Entity Review
- Judicial Off-Label Activism
- Crying Fire!
- Figure: Drug ADEs and Off-Label vs. On-Label Prescribing
- The Coming Flood