
By Laura C. Conway
On December 3, 2012, the United
States Court
of Appeals for the Second Circuit ruled that a pharmaceutical sales
representative could not be convicted for truthful off-label promotional
statements made to physicians about a drug that had been approved by the FDA
for other uses. United States v. Caronia, 09-5006-cr (2d Cir. Dec. 3, 2012).
Caronia was a sales representative who
promoted Xyrem, a drug that was approved for two specific uses and carried a
“black box warning.” Caronia detailed
physicians who might prescribe the product and helped establish a speakers
program where the drug was discussed. During
the course of a government investigation, Cardonia was recorded promoting the
drug for unapproved uses, including unapproved indications and unapproved
subpopulations. The government did not
allege that the statements at issue were untruthful or misleading.
Caronia was convicted in the trial court for
conspiracy to introduce or deliver misbranded drugs into interstate commerce,
in violation of the Food, Drug and Cosmetic Act (FDCA). The Second Circuit vacated this
conviction. The government, according to
the court, incorrectly argued that off-label promotion alone constitutes
“misbranding.” The court found that the
FDCA does not expressly prohibit the promotion of drugs for off-label use, but
noted that promotional statements could constitute proof of an intent to use a
drug in a manner that the FDA had not approved and was inconsistent with the
label, which would be actionable under the FDCA.
The court concluded that the government
prosecuted Caronia not for his intent to sell misbranded drugs based on his
statements regarding the drug’s off-label uses, which does not implicate the
First Amendment, but rather for the act alone of making statements about
off-label uses for the drug, which does implicate the First Amendment. The court held that the First Amendment
protects this type of commercial speech and that the government could not
overcome the heightened scrutiny applicable to such commercial speech. The court looked to the United States Supreme
Court’s recent decision, Sorrell v. IMS
Health, in which the Court held that “[s]peech in aid of pharmaceutical
marketing . . . is a form of expression protected by the Free Speech Clause of
the First Amendment." 131 S. Ct. 2653, 2659 (2011).
In reaching its decision, the Second
Circuit reasoned that the statements were truthful; the FDCA does not expressly
prohibit the promotion of drugs for off-label use; physicians are permitted to
prescribe the drug for unapproved uses, and persons other than pharmaceutical
companies and their sales representatives may advise physicians of off-label
uses of drugs that the FDA had approved for other uses. The court interpreted the misbranding
provisions of the FDCA as “not prohibiting and criminalizing the truthful
off-label promotion of FDA-approved prescription drugs” and concluded that “the
government cannot prosecute pharmaceutical manufacturers and their
representatives under the FDCA for speech promoting the lawful, off-label use
of an FDA-approved drug.”
The court noted that its decision was
limited to FDA-approved drugs for which off-labels uses are permitted and that
the FDA is authorized to regulate prescription drug marketing. In addition, the court made clear that
off-label promotion that is false or misleading is not protected by the First Amendment.
One of the three judges on the panel
dissented from the decision and issued a lengthy opinion arguing that Caronia’s
conviction should have been upheld. In
this dissent, the court disagreed with the majority’s interpretation of the
government’s position and contended that Caronia was prosecuted because his
speech revealed an intent to sell the drug for a use that was inconsistent with
the drug’s label, not for the speech itself.
As such, the court noted, the First Amendment did not apply and did not
protect Caronia’s statements. Even if
the First Amendment did apply, the dissent stated, the FDCA’s misbranding
provision precludes promotion of off-label uses and passes constitutional
muster. The dissent argued that the
majority opinion serves as a disincentive to pharmaceutical manufacturers to go
through the premarket drug approval process and undercuts the purpose of the
FDCA and the FDA to ensure the safety and efficacy of drugs before they are
marketed.
The Caronia decision is not binding on trial
courts outside of the Second Circuit and likely is not the last word on this
subject. We anticipate a request for
further review by the full panel of the Second Circuit or review by the United
States Supreme Court. Until the United
States Supreme Court reviews the decision, off-label promotion is subject to
prosecution outside of the Second Circuit.
In addition, both in and out of the Second Circuit, off-label promotion
by sales representatives remains potentially actionable because, among other
things, the government could argue that it is evidence of an intent to sell a
misbranded drug.
Full Text of Decision: United States v. Caronia, 09-5006-cr (2d Cir. Dec. 3, 2012)
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