The recent assault on the FDA’s jurisdiction on regulating off-label speech came to a head with the Amarin case. In that case, the FDA was told by a Judge in the 2nd Circuit that prohibiting “truthful and non-misleading” speech simply because it is disfavored is prohibited. This led to follow-up cases including a case filed by Pacira Pharmaceuticals on Sept. 8, 2015. Pacira sued for multiple reasons including the FDA’s effective retroactively reduction in scope of Exparel’s approval.

The FDA and Pacira negotiated and settled the issue in a manner favorable to Pacira on, or about, December 15, 2015. The core elements of the settlement included the following:

  1. The U.S. Food and Drug Administration (FDA) confirms that EXPAREL has, since its approval on October 28, 2011, been approved for “administration into the surgical site to produce postsurgical analgesia” in a variety of surgeries not limited to those studied in its pivotal trials.
  2. EXPAREL may be admixed with bupivacaine—including co-administered in the same syringe—provided certain medication ratios are observed.
  3. The September 2014 Warning Letter is formally withdrawn via a “Rescission Letter  from Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research (CDER) to Dave Stack.

It is important to recognize that a recision of a warning letter is practically unheard of – and heralds a dramatic shift in the FDA’s perspective. The settlement demonstrates that the FDA is changing its requirement of promotion based only on “substantial evidence.” Accordingly, it is important to recognize that this may impact both your MLR/PRC review processes and also your medical affairs, HECOR, and sales and marketing teams.