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Boston University Law School




The Food, Drug, and Cosmetic Act (FDCA) requires that, prior to marketing a drug, the manufacturer must prove that it is safe and effective for the manufacturer’s intended uses, as shown on the proposed label. Nonetheless, physicians may prescribe drugs for other “off-label” uses, and often do so. Still, manufacturers have not been allowed to promote the unproven uses in advertisements or sales pitches.

This regime is now precarious due to an onslaught of scholarly critiques, a series of Supreme Court decisions that enlarge the First Amendment, and a landmark court of appeals decision holding that the First Amendment precludes the Food and Drug Administration (FDA) from regulating off-label promotional claims. These critiques strike at the very core of the FDCA, calling into doubt the constitutionality of the entire premarket approval regime.

This Essay makes three critical contributions and offers a constructive approach to the regulation of drug promotion. First, this Essay examines the notion that “truthful” promotional claims enjoy First Amendment protection and illustrates how it has been central to scholarly and judicial critiques. Such critiques, however, have simply presumed the predicate of truthfulness – that the drugs are safe and effective for the newly intended uses, and further presumed that FDA is acting paternalistically to protect the public from acting upon the truth. Second, this Essay clarifies that the truth is unknown, and that this ignorance is itself the motivation for regulation. The very purpose of the FDCA is to incentivize drugmakers to invest in producing that missing knowledge. Third, this Essay highlights the way courts currently use the Daubert doctrine analogously to regulate scientific speech presented in their own courtrooms, noting that it is a prior restraint on speech that has received virtually no First Amendment scrutiny. Courts do not simply presume truthfulness.

In future FDCA enforcement actions, courts should defer to FDA’s premarket approval process as the test for the truth of promotional claims, and thus the claims’ status under the First Amendment. Accordingly, courts should remain in epistemic equipoise until the drugmaker proves safety and efficacy. Nonetheless, if the courts refuse to defer to the coordinate branches in the established expert regulatory process, they should instead put the burden upon the drugmaker to prove its claims true in court. Even under this fallback position, drugmakers will remain incentivized to produce the epistemic basis to support their claims of safety and efficacy. Thus the FDCA can play an appropriate role even within an enlarged conception of the First Amendment.

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