Compliance Management

Pacira Pharma Sues FDA Over Right to Promote Pain Relief Drug

Sep 09, 2015

Pacira Pharmaceuticals Inc. filed a lawsuit against the U.S. Food and Drug Administration (FDA) seeking to exercise its lawful rights to communicate truthful and non-misleading information about its flagship product, EXPAREL® (bupivacaine liposome injectable suspension). EXPAREL was approved in 2011 for administration into the surgical site to produce postsurgical analgesia.

According to a press release, the complaint outlines the Company’s belief that the FDA has violated the Administrative Procedure Act (APA), Fifth Amendment, and its own guidance materials and precedent by threatening enforcement action for promoting EXPAREL consistent with its approved indication. Additionally, the lawsuit alleges that the FDA violated the First Amendment rights of Pacira and the co-plaintiffs by restricting the exchange of truthful and non-misleading speech. The complaint, which was filed in the United States District Court for the Southern District of New York, can be accessed here:

Dave Stack, president, CEO and chairman of Pacira, said, “EXPAREL is an effective alternative to opioid-based postsurgical pain management, which is critically important to patient care as our nation battles an opioid addiction epidemic. In filing this lawsuit, we aim to restore our lawful right to communicate truthful and non-misleading information about EXPAREL consistent with the broad indication, for administration into the surgical site for postsurgical analgesia, granted by the FDA in 2011. It is unfortunate that the Agency’s unwillingness to respond to repeated requests for discussion around these issues have left us with no choice but to take legal action.”

Read the full release