US v. Caronia and CER Communications

A landmark appeals court ruling could open the door for the pharmaceutical industry to discuss information about comparative effectiveness research (CER) results, even when the data examines off-label uses of drugs. In United States vs. Caronia, a federal appeals court yesterday validated the right of pharmaceutical manufacturers and their employees to promote off-label uses of drugs, provided the information is factual.

The decision could have significant implications for industry, which had been restrained from fully participating in the CER conversation. The Food and Drug Administration regulates the type of research that industry can discuss in most forums. In this environment, manufacturers ran the risk of incurring stiff fines and penalties by discussing off-label uses. The Second Circuit Court of Appeals’ decision to vacate the criminal conviction of a pharmaceutical sales representative who promoted an off-label use of the narcolepsy drug Xyrem could lead to an environment where CER can be discussed more broadly among all stakeholders.

Learn more about this issue by viewing brief videos and presentations from NPC's conference, "Asymmetry in the Ability to Communicate CER Findings," and read related articles from Health Affairs.