Is off-label drug promotion–promotion of drugs for uses other than those approved by the FDA — good, bad, or something in between? What can the FDA do to curb off-label promotion by drug sellers consistent with the First Amendment? Law professors Stephanie Greene and Lars Noah have recently debated the issue in writing in Off-Label Drug Promotion and the First Amendment published in the University of Pennsylvania Law Revew.
The Greene-Noah debate was spurred by the Second Circuit's December 2012 decision in United States of America v. Caronia, which held, 2-1, that a drug-industry sales representative who promoted a drug's off-label use (and was criminally convicted under federal law) "was convicted for his speech." That, the court majority said, violated the First Amendment, and so the court reversed the conviction. The majority stressed that the off-label use itself was lawful.
Here is the abstract of the Greene-Noah debate:
Off-label promotion — pharmaceutical manufacturers’ marketing of FDA-approved drugs for unapproved uses — is considered a First Amendment right by some, a threat to the safety and effectiveness of pharmaceutical drugs by others. Although off-label prescription is legal and often beneficial, the Federal Food, Drug, and Cosmetic Act (FDCA) and corresponding FDA regulations effectively prohibit off-label promotion. The FDA can look to statements by pharmaceutical representatives as evidence of a drug’s intended use, thereby placing manufacturers that promote off-label in a Catch-22: the drug will be subject to the FDCA’s misbranding provisions if manufacturers add labeling instructions for that intend- ed use, but also if they fail to add those instructions. To legally promote a new intended use, pharmaceutical companies must satisfy the FDA’s rigorous approval process. In United States v. Caronia, the Second Circuit Court of Appeals ruled that the FDCA could not be interpreted to prohibit truthful, off-label promotion.
Professors Stephanie Greene and Lars Noah debate the constitutionality of the FDA’s prohibitions in light of Caronia and the Supreme Court’s increased deference to commercial speakers’ First Amendment rights. Professor Greene argues that Caronia was wrongly decided because the court failed to scrutinize the nature of off-label promotion. Greene contends that the truthfulness of off- label information is "speculative, unknown, or inaccessible," and that the FDA’s restrictions on off-label promotion serve two substantial interests: ensuring that both doctors and consumers receive accurate, scientifically based information, and assuring that drugs have been proven safe and effective. Professor Noah questions Greene’s assumption that promotion of off-label drug uses is pre- sumptively untruthful or misleading. He argues that Supreme Court precedent cuts against Greene’s position, and that the FDA’s restrictions on off-label promotion are unconstitutionally broad because they prevent drug manufacturers from disseminating even truthful and nonmisleading information, and because the FDA could accomplish its goals through less-speech-restrictive means.