In light of the decision of 2nd U.S. Circuit Court of Appeals in U.S. v. Caronia, the Pharmaceutical Research and Manufacturers of America (PhRMA) is advocating for the Food & Drug Administration (FDA) to change its regulations to allow for certain types of off-label promotion. As a representative from PhRMA noted — “It’s time for the FDA’s regulations to catch up to where the courts are.”
In December, the 2nd Circuit held that the FDA rule banning pharmaceutical manufacturers from truthfully and accurately speaking about a drug’s unapproved uses (“off-label promotion”) was a violation of the First Amendment and an individual’s freedom of speech. PhRMA would like to see FDA regulations allow for off-label promotion, including discussion of “clinical trial data, payor data and other information that is truthful, informative, accurate and not misleading, and that doesn’t leave out material information.”
A change in regulations would mean significant money for pharmaceutical companies, both in increased profits from drug sales and savings from penalties associated with false advertising/ off-label promotion. For example, Pfizer paid $491 million last November to settle a federal marketing investigation and GlaxoSmithKline paid $3 billion last summer to settle a False Claims Act suit that included allegations of off-label promotion.
The FDA, however, does not share PhRMA’s views. Specifically, the agency does not believe Caronia will significantly affect its enforcement of the drug misbranding provisions of the Food, Drug and Cosmetic Act (FD&CA). The FDA noted that Caronia did not strike down any provision of the FD&CA or its implementing regulations and that the decision did not find a conflict between the FD&CA’s misbranding provisions and the First Amendment. Further, the FDA does not find anything wrong with its current ban on off-label promotion of drugs.
If you have any questions regarding potential off-label issues or FDA labeling and marketing regulations in general, please contact one of the authors.