- On September 22, 2014, the FDA issued a warning letter to Pacira Pharma for marketing its painkiller Exparel for unapproved purposes.
- Pacira filed a lawsuit against the FDA alleging that the FDA retroactively revised Exparel's labeling and that the company's pivotal trial supported its claim via extrapolation of clinical trial data. The FDA has now apparently pulled its warning letter, Pharmalot reports.
- This is the latest action resulting from pharma companies' pushing back and attempting to protect their First Amendment rights. This movement dates back to 2012 when an appeals court overturned the conviction of a sales rep from Orphan Medical (now Jazz Pharmaceuticals) for promoting off-label usage of Xyrem, which is intended for narcolepsy. The basis was protection of First Amendment rights. The FDA also lost a recent case against Amarin regarding off-label marketing for the fish oil-derived drug Vascepa.
The letter that the FDA posted in response to its contention that Pacira was marketing Exparal for unapproved uses and overstating its efficacy is as harsh as any that it has posted in the past. But Pacira's reaction, a lawsuit alleging infringement of Freedom of Speech, is part of a relatively new movement, much of it sprearheaded by the the Medical Information Working Group.
The Medical Information Working Group includes Pfizer, Sanofi, Novartis, Johnson & Johnson, Eli Lilly, GlaxoSmithKline, and others. This group contends that there are cases in which off-label uses of drugs makes sense, especially when there is a major cost-differential involved and there is data supporting the safety and effectiveness of a drug in an off-label indication.
While this case is a continuation of a movement that has been underway for three years, removal of a warning letter is highly unusual, which raises the question of whether other warning letters may come down in response to company pushback asserting First Amendment privileges.