FDA Rescinds Warning Letter Regarding Exparel Use
Pacira Pharmaceuticals have reached an amicable resolution with the Food and Drug Administration (FDA) in their lawsuit concerning the indication of the analgesic, Exparel (bupivacaine liposome injectable suspension).
Exparel was initially approved by the FDA in 2011 for administration into the surgical site to produce postsurgical analgesia. In September 2014, the FDA sent a warning letter to Pacira over its Exparel promotional material stating that use of Exparel was limited to pivotal trial surgical models and not other surgeries.
After receipt of the letter, Pacira distributed corrective statements on Exparel, but ultimately they filed suit, “asserting that the FDA has silenced its speech in violation of the First Amendment; enforced vague policies in violation of the Fifth Amendment; and abruptly changed Exparel's approved labeling in violation of the Administrative Procedure Act.”
As a result of the resolution, the FDA has written a recession letter withdrawing their initial September 2014 warning. The practice of withdrawing warning letters is a very uncommon by the FDA. As well as withdrawal of the initial warning, the recession letter includes confirmation of Exparel's use in two procedures; infiltration into the transverses abdominis plane (TAP), and infiltration to produce postsurgical analgesia at the site of oral surgery procedures.
Labeling will also be updated to state that Exparel is approved for postsurgical analgesia in a variety of surgeries, and that dosage should be based on patient and procedure-specific factors.
Chief executive officer and chairman of Pacira, Dave Stack said the resolution over Exparel's indication was, “Especially important given the burgeoning US opioid epidemic, underscored by the reality that 1 in 15 patients will go on to long-term use after receiving an opioid in a hospital setting.”
It remains to be seen if this case could have any implications for future promotional material of prescription drugs approved by the FDA.