On Wednesday, the Food and Drug Administration announced that
the government has decided not to seek review of a landmark 2012 ruling by the 2nd Circuit Court of Appeals in U.S. v. Caronia.
As you probably recall, a split 2nd Circuit panel held in
December that the First Amendment protects truthful speech about
the off-label use of FDA-approved products, finding that the
misbranding provisions of the Food, Drug and Cosmetic Act do not prohibit off-label marketing, as long as it's not misleading.
Wednesday's announcement by the FDA means that in New York,
Connecticut and Vermont, pharmaceutical and medical device
makers can give physicians information about their products that
they can't discuss in other states without risking prosecution.
That disparity would have been a good reason for the
government to seek en banc or U.S. Supreme Court review of the
2nd Circuit panel's Caronia ruling, said Jeffrey Senger of
Sidley Austin, a former deputy chief counsel of the FDA. Senger
told me Thursday that the Justice Department, which litigates on
behalf of the FDA, undoubtedly considered whether it had a
responsibility to ask the entire 2nd Circuit or the Supreme
Court to clarify what pharma companies can and cannot say about
their products. (Former healthcare fraud prosecutor Michael
Loucks, now at Skadden, Arps, Slate, Meagher & Flom, told me the
same thing when the Caronia ruling came down last month.
"There's a downside to the pharmaceutical industry and to
society if the Justice Department shies away from further
review," Loucks said. "It's not helpful to drug or device
companies to have a lack of clarity. It's also not helpful to
the Justice Department.")
But there was also a downside for the government in pursuing
the Caronia appeal -- especially because the Supreme Court made
it clear in a 2010 case called Sorrell v. IMS Health that pharma
marketing is "a form of expression protected by the Free Speech
Clause of the First Amendment." Sorrell involved a Vermont law
restricting the sale of pharmacy prescription records, not
off-label marketing. Nevertheless, the ruling is considered a
good indicator of the justices' likely view of the issues in
Caronia. And losing at the Supreme Court would extend Caronia's
reasoning beyond the confines of the 2nd Circuit, which is just
what the Justice Department doesn't want. "I think the
government had a very substantial risk of losing at the Supreme
Court if they had appealed," said Senger, who added that the
decision to forgo an appeal did not surprise him.
Just filing a petition for certiorari would have sent a
message the Justice Department wants to avoid, Senger said. Cert
petitions typically urge the justices to review cases because of
their national significance. That would undermine the
government's depiction of Caronia as a narrow decision that will
not affect its prosecution of off-label marketing cases. Indeed,
the FDA statement on the decision not to appeal the 2nd Circuit
ruling said that the FDA does not believe Caronia will
"significantly affect the agency's enforcement of the drug
misbranding provisions" of the Food, Drug and Cosmetic Act.
Senger said the Justice Department can work around Caronia
by charging off-label marketing defendants with making false and
misleading statements, which are not protected by the First
Amendment. Whistle-blower lawyers have told me that it's rare
for the Justice Department to bring cases based only on truthful
statements about off-label drug efficacy, so restricting
prosecution to false marketing may not hinder the government.
And besides, Caronia won't be the Justice Department's last
crack at the issue of limits on off-label marketing. Only days
after the 2nd Circuit issued the Caronia decision, the 9th
Circuit heard another First Amendment challenge to an off-label
marketing conviction, this one by former InterMune CEO Scott
Harkonen, who was prosecuted for approving a supposedly
misleading press release about a pulmonary drug produced by the
company. Unlike Caronia, the Harkonen case involves allegations
of false statements, which could make it a more attractive
vehicle, from the Justice Department's perspective, for the
Supreme Court.
(Reporting by Alison Frankel)
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