Free-speech Protections May Alter Off-Label Promotions

The FDA has historically prohibited pharmaceutical companies from engaging in “off-label” promotion of its products. The Food, Drug, & Cosmetic Act also criminalizes misbranding by pharmaceutical companies. Misbranding occurs when a drug’s label does not provide instructions to allow for the safe use of intended indications. The FDA typically will not permit package inserts to provide information regarding off-label uses. Thus, the FDA interprets promotion of off-label uses as an intended indication and without these proper accompanying instructions, the action constitutes misbranding. Pharmaceutical manufacturers and their employees can be charged with misdemeanor and felony offenses and can be sanctioned with as much as three years’ imprisonment or a $10,000 fine.

While numerous pharmaceutical manufacturers have argued that this criminal prosecution violates their and their employees’ rights to free speech, the FDA has not altered its policy. Yet, the Second Circuit recently held that the FDA’s criminal prosecution of pharmaceutical manufacturers and their representatives for truthful, non-misleading speech promoting an FDA-approved pharmaceutical product unconstitutionally encroaches upon the First Amendment. U.S. v. Caronia, No. 09–5006–cr, 2012 WL 5992141 (2d Cir. Dec. 3, 2012).

The Second Circuit applied heightened scrutiny to the FDA’s prosecution and concluded first, that the government’s band did not directly advance its interest and second, that the government’s prohibition was not narrowly tailored to achieve its interest. The FDA claimed that its interest in the regulation was to promote the integrity of the approval process and limit the public’s exposure to unsafe or ineffective products. However, the Second Circuit reasoned that because physicians are allowed to prescribe approved drugs for off-label uses, the FDA’s ban did not limit off-label use or protect the public. Further, by stifling the flow of truthful communication, the FDA prohibition denied prescribers and patients important information about that product, including safety information. Finally, the FDA’s actions also were not narrowly tailored as the FDA could prohibit off-label uses, cap off-label prescriptions, or launch educational campaigns to achieve its interests more narrowly.

The FDA is expected to appeal the decision by either petitioning for en banc review by the Second Circuit or for a grant of certiorari by the Supreme Court. Until appellate options are exhausted, the FDA is unlikely to alter its regulations concerning off-label promotion. If the FDA is forced to change its regulatory scheme, pharmaceutical manufacturers will likely still need to be vigilant that communications could not be construed as “untruthful” or “misleading” to escape disciplinary action by the FDA.