• Pacira Sues FDA, Alleging It Illegally Attempted to Restrict Truthful and Non-Misleading Speech about Its Post-Surgery Pain Drug Exparel
  • October 19, 2015 | Author: Scott S. Liebman
  • Law Firm: Loeb & Loeb LLP - Washington Office
  • The drugmaker filed a First Amendment suit seeking an injunction to prevent the regulator from taking enforcement action against it over what Pacira says is truthful and non-misleading promotion of Exparel, and alleging the FDA retroactively attempted to revise the drug’s label to limit its approved indication.

    Pacira v. FDA joins Solis v. Millennium and Amarin v. FDA among First Amendment cases for the pharmaceutical industry to watch in 2015. According to a complaint filed in New York federal court, the FDA issued a Warning Letter to Pacira ordering it to stop sharing certain information with surgeons, anesthesiologists and other “sophisticated audiences” about using Exparel for purposes other than bunionectomy or hemorrdoidectomy surgeries. The letter stated some of the drugmaker’s speech established “new intended uses” for the painkiller.

    However, Pacira says the drug’s FDA-approved label reflects that it’s approved for use in surgical sites generally, not exclusively in bunionectomy or hemorrdoidectomy surgical sites. Thus, the company contends the FDA is trying to retroactively narrow Exparel’s indication to restrict its use to bunionectomy or hemorrdoidectomy surgeries.

    Pacira’s complaint goes beyond defending what it believes is its on-label marketing, pointing to 2012’s United States v. Caronia decision in the 2nd Circuit and U.S. District Judge Paul Engelmayer's ruling last month in the Amarin case to argue that off-label marketing is allowed as long as it’s done truthfully. Thus, Pacira claims even if Exparel’s approved uses were limited to bunionectomy or hemorrdoidectomy surgeries, the FDA isn’t authorized to prohibit the company from communicating truthful and non-misleading information to surgeons and anesthesiologists about the use of the drug to control post-operative pain in other surgical sites.