By Nate Raymond
(Reuters) - Lawyers representing pharmaceutical companies
and a top U.S. Food and Drug Administration official debated the
significance of a recent off-label-marketing ruling during a
The discussion, held Friday at a meeting of white-collar
lawyers in Las Vegas, flowed from the 2nd U.S. Circuit Court of
Appeals' decision in December to overturn the conviction of
pharmaceutical sales representative Alfred Caronia on free
The decision, United States v. Caronia, sent ripples through
the pharmaceutical industry, which has in recent years faced a
number of prosecutions and investigations over the promotion of
various drugs for off-label purposes.
At the legal conference, sponsored by the American Bar
Association, the director of the FDA's criminal investigations
office said the agency reviewed five years of cases after the
2nd Circuit ruling.
"We were unable to identify a single case in which we would
not have been able to move forward under the standard set" in
the case, said John Roth.
In the Caronia decision, a 2nd Circuit panel ruled 2-1 that
the U.S. government had wrongly prosecuted the salesman for
promoting the narcolepsy drug Xyrem for off-label uses including
excessive daytime sleepiness and muscle disorders.
Circuit Judge Denny Chin wrote that prohibiting
manufacturers from promoting off-label use created a barrier for
doctors and patients to receive information, and that "could
inhibit, to the public's detriment, informed and intelligent
The FDA in January announced it would not appeal the
decision, saying it did not believe the decision would
"significantly affect the agency's enforcement of the drug
misbranding provisions of the Food, Drug, and Cosmetic Act."
9TH VS 2ND CIRCUIT
At the ABA conference, defense lawyers said the 2nd
Circuit's ruling was "psychologically important" because it
showed that off-label use was a sensitive area and that
scientific debate was important, said Joseph Savage, a defense
lawyer with Goodwin Procter.
"An unduly aggressive approach by prosecutors might actually
harm patient safety because it might deter exchange," Savage
said. "There's a reason doctors are allowed to do things off
label because it advances the health of the patient."
However, Savage also said the 2nd Circuit ruling might not
be as earth-shattering as it might have first appeared.
For example, the ruling didn't prevent the U.S. Justice
Department from pursuing cases where the statements made to
doctors and patients were fraudulent, Savage pointed out. As a
result, "it's hard to figure out if that case matters very
much," he said.
He brought up last week's case at the 9th U.S. Circuit Court
of Appeals, which upheld the conviction of former InterMune CEO
Scott Harkonen, rejecting his First Amendment defense of charges
he misrepresented the results of a clinical drug trial.
Savage said some had expected the 9th Circuit case to become
a sequel to the 2nd Circuit's. The ruling instead showed that
under the rubric of mail and wire fraud, the government was
prepared to go after fraudulent statements, he said.
John Richter, a partner at King & Spalding and a former U.S.
Attorney for Oklahoma City, Oklahoma, said his firm was pursuing
a "number of cases" asserting First Amendment defenses.
While the 2nd Circuit decision hadn't fundamentally changed
the landscape in terms of avoiding enforcement, the ruling had
created "important leverage" to resolve cases favorably,
particularly before an indictment was brought, said Richter.
"I do think the opportunity to engage in discussion on the
question of truth cracks the door open in a way that allows for
advocacy and open discussion at the pre-charge level," he said.
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