Pacira Sues FDA Over Drug Marketing Restrictions

The FDA is violating Pacira Pharmaceuticals Inc.'s free speech rights by limiting what the company can say about its pain management drug Exparel (bupivacaine liposome injectable suspension), the drugmaker said in a complaint filed Sept. 8 (Pacira Pharmaceuticals, Inc. v. FDAcomplaint filed).

The company’s complaint, filed in the U.S. District Court for the Southern District of New York, also alleges that the Food and Drug Administration is violating the Administrative Procedure Act (APA), the Fifth Amendment’s due process clause and the agency’s own guidance materials and precedent by threatening the company with enforcement action for promoting Exparel consistent ...