The First Amendment and the Regulation of Pharmaceutical Marketing: Challenges to the Constitutionality of the FDA's Interpretation of the Food, Drug, and Cosmetics Act
Cohen, Thea, American Criminal Law Review
Doctors in the United States write more than twenty percent of prescriptions for "off-label" uses. (1) The term "off-label" refers to the use of a drug to treat a condition not indicated in the Food and Drug Administration (FDA)-approved "label." (2) Medical professionals often consider off-label use to be state of the art treatment because medical discoveries regarding new uses for existing drugs typically outpace the FDA's relatively slow regulatory process. (3) In patients with rare or very serious illnesses, the prevalence of off-label drug prescription is even higher. According to one study, eighty percent of terminal cancer patients were prescribed drugs that were not FDA-approved because doctors considered FDA-approved therapies to be ineffective. (4) In addition to prescribing drugs for unapproved uses, doctors also prescribe drugs to certain categories of patients (particularly pregnant women and children) even when those drugs have not been FDA-approved for use by that type of patient. (5) Drug companies often do not seek FDA approval for use in these "orphan populations" because the companies consider the cost of obtaining FDA approval for those patients to be too onerous. (6)
Though off-label drug use can be beneficial and is sometimes necessary, (7) prescribing a drug for a use not approved by the FDA carries certain risks. The purpose of the FDA's rigorous approval process is to protect consumers from potentially dangerous drugs. (8) And in some cases, unethical marketing practices on the part of pharmaceutical companies have harmed consumers. (9) When a doctor prescribes a drug for an off-label use, she does so without the assurance the drug has undergone rigorous safety and efficacy testing. (10) Manufactures are generally prohibited from promoting drugs for unapproved purposes. The prohibition covered truthful and false information alike, and applies even when the communication is made directly to a doctor who is legally privileged to write a prescription for the off-label use.
These restrictions raise serious First Amendment concerns because the FDA's regulatory scheme criminalizes speech based on the identity of the speaker and the content of the speech. In December of 2012 the Second Circuit held in a two-to-one decision that the First Amendment prevented the FDA from construing the Food, Drug, and Cosmetics Act ("FDCA" or "Act") in such a way that it prohibited truthful promotion of an FDA-approved drug for an off-label use. (11) The FDA did not seek certiorari, but issued a statement indicating the agency would continue to pursue manufacturers who engage in off-label marketing. (12)
This Note argues that in light of three recent cases, Citizens United v. Federal Election Commission, (13) Thompson v. Western States Medical Center, (14) and Sorrell v. IMS Health, Inc. 15 the Supreme Court will find the FDA's current regulatory scheme unconstitutional. Those cases indicate the Court is unwilling to apply the relatively lenient test for commercial speech when a regulation on advertisement is directed at the message's content. Instead, the Court will in all likelihood apply a test that is the functional equivalent of strict scrutiny. Part II explains the FDA's current interpretation of the FDCA. Part III explains the Supreme Court's precedents that are likely to be relevant to resolving the question of whether the First Amendment protects off-label marketing, and explains how the doctrine has shifted in favor of commercial speech. Part IV describes the Second Circuits decision in United States v. Caronia, and the government's response. Though the government has tried to reframe the prohibition on off-label promotion and now argues such promotion is merely evidence of an unlawful intent to distribute misbranded drugs, this Note concludes that under the current commercial speech doctrine, the Court would still find that the FDA's interpretation places an impermissible burden on protected speech. …