We posted late last year about a Second Circuit decision that circumscribed the government's authority to criminalize off-label prescription-drug promotion on First Amendment grounds. Now, law professor Christopher Robertson has written "When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under an Expanding First Amendment," which discusses the issue. Here is the abstract:
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, such that a large portion of U.S. healthcare spending
is consumed by such unproven uses. 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, as a prior restraint on speech. This
Essay makes three critical contributions, and offers a constructive
approach to the regulation of drug promotion. First, this Essay reveals
how the notion that “truthful” promotional claims enjoy First Amendment
protection has been central to these scholarly and judicial critiques.
However, those critiques have simply presumed the predicate of
truthfulness – that the drugs are safe and effective for the newly
intended uses, and further presumed that the FDA is acting
paternalistically to protect the public from acting upon the truth.
Second, this Essay clarifies that the truth is unknown, and this
ignorance is itself the motivation for regulation. The FDCA incentivizes
drugmakers to invest in producing that missing knowledge. Third, this
Essay highlights the way courts currently use the Daubert
doctrine 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. Going forward,
in FDCA enforcement actions, courts should defer to the FDA’s pre-market
approval process as the test for the truth of promotional claims, and
thus their 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 that established expert regulatory process, the courts
should 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 have a secure place even within
an enlarged conception of the First Amendment.
