The Impact of Caronia Case: What Happens Next?

Last month, in a landmark ruling, the United States Court of Appeals for the Second Circuit in United States v. Caronia, vacated the criminal conviction of a pharmaceutical sales representative who was found guilty of conspiracy to introduce a misbranded drug, under the Food, Drug & Cosmetic Act (FDCA), because he spoke about off-label uses of a particular drug.  The court held “that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.”  In a client alert written by the law firm Arnold & Porter, LLP—which are the counsel representing Par Pharmaceutical in their similar First Amendment case—the FDA attorneys noted how the Second Circuit “applied the First Amendment analysis set forth in Sorrell v. IMS Health Inc., a case that Arnold & Porter handled at the trial and appellate stages, including the petition and merits phases in the U.S. Supreme Court.”  The Caronia court explained “that FDCA prosecutions premised on off-label promotion impermissibly discriminate against pharmaceutical companies based on the content of their speech.  Anyone other than pharmaceutical companies, even individuals or entities outside the healthcare field, may freely discuss off-label uses of approved drugs.  Yet, under the government’s theory of prosecution, the same speech becomes criminal when uttered by pharmaceutical companies – entities wh...
Source: Policy and Medicine - Category: Health Medicine and Bioethics Commentators Authors: Source Type: blogs