FDA loses off-label marketing suit against Amarin in major setback
- The FDA's position against off-label marketing of drugs took a major blow last week as a federal district court ruled that Ireland-based Amarin could promote its fish oil-derived drug Vascepa for off-label use.
- In its ruling, the court decided that off-label promotion cannot be restricted by the FDA as long as drug makers' claims are truthful.
- Vascepa is used to treat patients with severly high levels of triglycerides—but Amarin has been seeking an indication for patients with lower levels of triglycerides.
This is a case and ruling that cuts to the heart of the FDA's regulatory regime when it comes to drug marketing.
For years, drug manufacturers have argued that the First Amendment allows them to promote products as long as their claims are supported by evidence and not deceptive. Now, the industry has a powerful ruling to support that contention.
Legal analysts are saying that the FDA will now have to review its off-label promotion regulations, and figure out a way to narrow the scope of drug marketing without running afoul of companies' free speech rights.