FDA said in a statement that the government decided not to seek further review of a December decision that found that the federal government could not prosecute a sales representative for speech promoting the legal, off-label use of an FDA-approved drug. According to the statement, the agency does not believe the 2-1 decision from the U.S. Court of Appeals for the Second Circuit in United States v. Caronia "will significantly affect the agency's enforcement of the drug misbranding provisions" of the Food, Drug and Cosmetic Act (FDCA). FDA added that the decision "does not strike down any provision [of FDCA] or its implementing regulations, nor does it find a conflict between the act's misbranding provisions and the First Amendment or call into question the validity of the act's drug approval framework"
Surprised? Don’t be. Whenever the FDA goes to court on First Amendment issues it either loses or gets a stern rebuke for its unpredictable, ambiguous and sometimes capricious application of off-label speech constraints.
Regardless of the FDA’s decision, Caronia will impact the way FDA views off-label promotion within the context of the free-and-fair dissemination of scientific data. I believe a new (and hopefully more enlightened) FDA view based on intent will arise. Alas, that will not assuage any of the ambiguity that is currently driving FDA (OPDP) communications oversight. That being said, any revisitation and discussion is for the better.
Some believe that, if Caronia stands, pharmaceutical companies will no longer feel obligated to seek FDA approval for new indications, since they can openly "promote" them without fear of prosecution. This is a flawed argument. Indications of the on-label variety have many benefits—not the least of which is reimbursement. But such negative unintended consequences are important to discuss and consider. IMHO, any company that chose this route would be acting in a highly irresponsible manner, putting promotion before the public health.
“See you in court?” Not likely.
