Off-Label 'Promotion' May Not Be Merely Commercial Speech

Abstract

Most attorneys (whether in practice or academia) assume that pharmaceutical companies’ discussion and dissemination of information regarding “off-label” uses of prescription drugs (i.e., uses that have not been specifically approved by the Food and Drug Administration (FDA)) are inherently commercial in nature. Two aspects of the speech, however, suggest that it does not cleanly fall into the category of “commercial speech” for purposes of First Amendment analysis. First, most prescribers are not, in fact, purchasing drugs for their patients, and so conversations between pharmaceutical company representatives and prescribers are not directly linked to a commercial transaction the same way they are with an advertisement or sales pitch to an end consumer. Second, prescribers are “learned intermediaries,” charged by profession and law to research and weigh the range of potential risks and benefits of each product they prescribe for their patients, whether it is prescribed for an FDA-approved use or an off-label use. As a result, scientific and medical information is “inextricably linked” to any speech that would be considered merely commercial. Prior attempts to restrict speech that included both financially driven and noncommercial components have received exceptionally rigorous scrutiny when reviewed by the Supreme Court. This Article suggests that the current restrictions on some pharmaceutical company speech may be given what I shall call “enhanced intermediate” (or even strict) scrutiny, rather than the usual intermediate scrutiny given to restrictions of merely commercial speech, because of the unique professional and legal role played by prescribers.