First Amendment Protection of Evidence-Based Promotion of Prescription Drugs: A Study of Published Clinical Evidence Supporting Off-Label Promotion in the USA

Abstract

A heated debate surrounds pharmaceutical companies’ proactive dissemination of information about uses of their drugs beyond those approved by the US Food and Drug Administration (FDA), a practice commonly referred to as “off-label promotion”. At the core of this debate is an underlying assumption that pharmaceutical company speech about off-label uses is inherently false and misleading and not in the best interests of patients. If, however, the companies’ off-label speech is truthful and not misleading, the speech may be protected by the First Amendment, making the FDA’s prohibition of off-label promotion unconstitutional. This study is the first to link alleged pharmaceutical company speech with published clinical evidence bringing data to inform the debate. To evaluate whether pharmaceutical company speech alleged in False Claim Act (FCA) complaints is supported by published clinical evidence. Reviewed were 66 FCA complaints alleging off-label promotion of branded prescription drugs. Indications in these complaints were matched to published clinical evidence using a nationally recognized compendium, Micromedex® 2.0. Of the uses alleged in FCA complaints, 51.6% (at least 22.1% of which were off-label) were supported by at least some published clinical evidence and, therefore, not inherently false or misleading. Given this evidence, the current government policy of prohibiting proactive dissemination of off-label information by manufacturers may not be consistent with the First Amendment. Some of the off-label uses alleged in FCA complaints investigated and settled by the federal government were supported by published clinical evidence; however, many of the alleged uses were unsupported by any clinical evidence and, thus, false and misleading. These results suggest that government regulation of pharmaceutical company speech remains warranted because company speech is not consistently evidence-based. Even so, evidence-based pharmaceutical company speech is protected by the First Amendment. As a result, the federal government’s historic practice of prohibiting all off-label promotion may be unconstitutional.