Off-label statements and conduct of pharmaceutical manufacturers that rise to the level of misbranding under the Federal Food, Drug & Cosmetics Act are not protected by the First Amendment.
On May 17, 2016, the United States Court of Appeals for the Second Circuit affirmed dismissal of a False Claims Act case against Pfizer, holding that National Cholesterol Education Program (NCEP) Guidelines as to the prescription of Lipitor were advisory rather than mandatory or required by the FDA-approved label. Accordingly, marketing outside these Guidelines did not constitute off-label promotion as relator claimed.
Although this direct holding has garnered the most attention from the legal world, the Court’s clarification and cabining of its decision in United States v. Caronia is by far the more broadly significant aspect of its decision.
In the controversial decision of United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), the Second Circuit held that the FDCA does not prohibit or criminalize the promotion of a drug’s off-label use if the promotion is truthful and not misleading in order to avoid First Amendment concerns. However, the Caronia court reaffirmed that off-label promotion that was false or misleading did not enjoy constitutional protection. The decision was praised by pharmaceutical manufacturers but criticized in many other quarters. The decision is not binding outside the Second Circuit and has been sharply cabined or rejected outright by district courts in other jurisdictions. Likewise, in response to a post-Caronia bill designed to loosen the restrictions on off-label promotion, the White House issued a Statement of Administration Policy explaining that the bill “could undermine regulatory standards by allowing unproven uses of therapies to be marketed to health care payors as though such uses had been proven safe and effective.”
In Polansky, a unanimous decision by the Second Circuit itself has now cabined Caronia and identified additional conduct (and statements in furtherance thereof) that do not enjoy constitutional protection. Citing to Caronia for the proposition that there is potential value to off-label drug use and that certain off-label statements by manufacturers are permitted, the Court carefully identified off-label statements and conduct that is not constitutionally protected. The Court explained that pharmaceutical manufacturers “are generally prohibited from promoting off-label uses of their products if the off-label marketing is false or misleading, or if it evidences that a drug is intended for such off-label uses and is therefore misbranded.” (emphasis added). The Court further explained that a drug is misbranded “if its labeling lacks ‘adequate directions’ for safe use by a layperson ‘for the purposes for which it was intended” and affirmed that “Caronia left open” the “government’s ability to prove misbranding on a theory that promotional speech provided evidence that a drug is intended for a use that is not included on the FDA-approved label.”
The implications are significant. For example, obtaining approval for one indication and intending to market and marketing a drug for a wholly different indication upon approval qualifies as misbranding under the law and would not be constitutionally protected speech or conduct under the Second Circuit’s decision in Polansky. Off-label statements made in furtherance of a manufacturer’s efforts to sell a drug for an indication unrelated to those for which it sought and obtained approval are not protected. Other jurisdictions continue to take a stricter view of permissible conduct and statements, refusing to affirm the existence of constitutional protection for any off-label promotion or statements by pharmaceutical manufacturers.
Caronia has not proven to provide the license to promote off-label that many anticipated, and pharmaceutical manufacturers should continue to proceed cautiously.
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 United States ex rel. Polansky v. Pfizer, Inc., 2016 U.S. App. LEXIS 8974, No. 14-4774 (2d Cir. May 17, 2016). Off-label promotion has long been recognized as a violation of the Federal, Food, Drug and Cosmetic Act (FDCA) and a predicate for False Claims Act liability. Since 2004, there have been at least 31 False Claims Act settlements where a predicate allegation has been promotion of a drug in violation of the FDCA. Many of these cases settled for billions or hundreds of millions of dollars.
 E.g. Hawkins v. Medtronic, Inc., No. 13-00499, 62 F. Supp. 3d 1144 (E.D. Cal. Feb. 15, 2016);Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp. 3d 1021 (D. Haw. 2014); McDonald-Lerner v. Neurocare Assocs., P.A., No. 373859-V, 2012 Md. Cir. Ct. (Md. Cir. Ct. Aug. 29, 2013).
 STATEMENT OF ADMINISTRATION POLICY: H.R. 6 – 21st Century Cures Act (July 8, 2015), available at https://www.whitehouse.gov/sites/default/files/omb/legislative/sap/114/saphr6r_20150708.pdf