Pharma's 1st Amendment battle rages on as Pacira, FDA reach Exparel settlement
- In September, Pacira filed a lawsuit against the FDA alleging infringement of First Amendment rights regarding its marketing of Exparel. Pacira won, and the non-opioid narcotic can now be labeled for postsurgical pain, not just pain specifically after bunion and hemorrhoid surgeries.
- Originally FDA labeling noted Exparel had not been studied for use with other surgeries (besides bunion and hemorrhoid surgeries). But the label did not explicitly say that Exparel can only be used in the context in which it was studied, leading Pacria to argue it could market the drug more widely.
- The market responded well to the news. At one point, the stock was up as much as 20%, after a steady decline of 31% during the last 12 months.
For years, drug manufacturers have argued the First Amendment allows them to promote products as long as their claims are supported by evidence and are not deceptive. Increasingly drug makers have been going to court to protect those rights. This summer, Amarin had a big win with its off-label marketing case, receiving affirmation it had a broad enough label to support the entirety of its communications.
Pacira notched a major win in this case. In the suit, Pacira claimed that the FDA retroactively revised Exparel's labeling and argued the company's drug trial supported its claim via extrapolation of clinical data. The FDA first withdrew a warning letter it had issued, and now it has agreed to a broader interpretation of the label for Exparel.
The FDA issued a statement on the Pacira agreement, emphasizing "this resolution is specific to the parties involved." Still, this may mark a broader trend.
On the financial side, not only is Pacira's stock up, but the long-term outlook is positive. Exparel sales are expected to hit $886 million by 2020, a fourfold increase over 2014 sales.