Relieving Pacira's pain

In September, when Pacira Pharmaceuticals Inc. asked a federal court to force FDA to lift restrictions on the company's promotion of Exparel bupivacaine, it looked like yet another drug company was launching a First Amendment challenge to the agency's enforcement practices. Based on the settlement filed with the court last week, it now looks like the controversy stemmed from a more prosaic cause: a management failure at FDA's Center for Drug Evaluation and Research.

The story starts in 2011, when CDER's Division of Anesthesia, Analgesia and Addiction Products (DAAAP) reviewed Pacira's NDA for Exparel, a liposomal extended-release version of bupivacaine, a generic analgesic...