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.
THE FDA's PRE-CARON1A INTERPRETATION OF THE FDCA
The prohibition on the promotion of drugs for off-label uses is not specifically spelled out in a statute or regulation. However, through a "patchwork of regulations, guidance documents, statements, prosecutions, letters, and consent decrees," (16) the FDA interpreted the FDCA to disallow pharmaceutical manufactures and their agents from providing truthful and non-misleading promotional information to physicians regarding off-label uses of prescription drugs. (17) The government has aggressively prosecuted manufacturers who provide information about off-label uses. (18) But the prohibition only applies to manufacturers and their agents-any other speakers (physicians, medical journals, ordinary people) are "free to say whatever [they] want about the off-label use." (19)
The FDA's regulatory scheme governing the criminalization of off-label marketing has been described as "Byzantine," (20) "murky at best," (21) and "a regulatory twilight." (22) But the penalties for violating the regime can be severe. Unlike most criminal statutes, individuals and corporations can be held strictly liable for FDCA violations. (23) The Act imposes felony culpability, punished by up to three years in prison and $10,000 in fines per violation, for repeat offenders or those who act with intent to defraud or mislead. (24) In addition, manufacturers may be subject to additional civil and criminal penalties, including treble damages under the False Claims Act. (25) As a result, settlements can reach millions or even billions of dollars. (26) Manufacturers can also face exclusion from future participation in Medicare or Medicaid, a loss which "would irrevocably cripple a company." (27)
This Part describes the evolution of the FDA's interpretation of the FDCA. Section II.A describes the text of the Act and explains the requirement that all drugs contain an adequate label. Section II.B discusses the FDA's regulations and explains that its interpretation of those regulations has created a general ban on off-label promotion.
The Text of the FDCA
Congress designed the FDCA to protect American consumers from dangerous and ineffective drugs. (28) Among other things, the FDCA prohibits the sale or receipt of any drug that is "misbranded," or the "misbranding" of any drug. (29) The purpose of this prohibition is to protect citizens by demanding manufacturers provide truthful information to enable ordinary people to use drugs in a safe and effective manner. (30)
The FDCA requires the FDA to approve all "new drugs" and a corresponding "label" before a drug is introduced into interstate commerce. (31) The statute defines a "new" drug as one "not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof." (32) Therefore, if a drug is only approved for one use, it is a new drug if the manufacturer intends to market it for any other use. (33) As a result, the manufacturer must apply to the FDA for approval to market the drug for a purpose not included on the original FDA-approved label. The manufacturer's application to the FDA (a "New Drug Application" or "NDA") must include "specimens of the labeling proposed to be used for such drug." (34) Once the drug is approved, the FDCA requires that a drug's "labeling bear adequate directions for use." (35) The label also must not contain any statements that are "false or misleading." (36) If the labeling is false or misleading or does not contain directions, the drug is "misbranded" for the purposes 21 U.S.C. [section] 331, and the manufacturer is subject to civil and criminal penalties. (37)
The FDA's Regulations: Finding the Prohibition on Off-label Marketing
The FDA has statutory authority to promulgate regulations governing the advertisement of prescription drugs. (38) Though on its face the provisions of the FDCA appear relatively straightforward, the FDA's interpretations have expanded and complicated the regulatory landscape considerably. The agency has created numerous rules regarding the form and content of advertising. (39) It has also specifically stated that an "advertisement" for a prescription drug "shall not recommend or suggest any use that is not in the labeling accepted" in that drug's new drug application. (40)
The term "labeling" is critical to the scope of the FDA's advertising regulations. The FDCA defines a "label" relatively narrowly as "a display of written, printed, or graphic matter upon the immediate container of any article" or "accompanying any such article." (41) However, the FDA's interpretation of a "label" is far broader and includes all communications--oral and written--relating to the drug. (42) Even information intended solely for the use of medical personnel and which does not actually accompany the drug is classified as a "label." (43)
Along with an expanded definition of "label," the FDA dramatically extended and complicated the definition of the term "misbranded" when it introduced the concept of "intended use." (44) The FDA's regulations define "intended use" as "the objective intent of the persons legally responsible for the labeling of drugs." (45) A manufacturer or representative's "labeling claims, advertising matter, or oral or written statements" can show "objective intent." (46) If the "intended use" is something other than the use described on the FDA-approved labeling, the manufacturer or seller "is required to supply adequate labeling in accordance with the new intended uses." (47) But "intended use" can also include uses the manufacturer never actually intended. The regulations state if "a manufacturer knows, or has knowledge of facts that would give him notice, that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other...
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.
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COPYRIGHT GALE, Cengage Learning. All rights reserved.
COPYRIGHT GALE, Cengage Learning. All rights reserved.