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Ultimate impact of Caronia decision uncertain, but FDA and prosecutors might be more careful

An appeals court decision has caused a stir in the pharmaceutical industry because it calls into question the FDA's prohibition on sales reps talking about drugs for use in ways not approved by the agency.

Two former prosecutors say the ultimate impact of the decision in U.S. v. Caronia won't be known until further court action, but in the meantime, former colleagues prosecuting cases might be more careful in forthcoming cases.

But the Dec. 3 opinion also doesn't give a free pass to pharmaceutical companies and their sales reps to say anything about any drug.

"I don't think this opinion is a license to do that," said Geoff Kaiser, who was one of the U.S. Attorney's in Brooklyn who brought the original charges against Orphan Medical, Alfred Caronia and doctor Peter Gleason for off-label marketing. "I don't think it establishes that it's okay for a pharmaceutical company to promote an unapproved indication."

Kaiser was in private practice by the time the charges against Caronia were reduced to misdemeanors, which Kaiser said was a factor in the outcome of the appeals decision. He also suspects that prosecutors have already spent more time searching for evidence of misdeeds before bringing charges, rather than relying on what a sales rep might have said. The majority opinion in Caronia, according to Kaiser, says, "You can't argue that words themselves are the offensive conduct."

It is uncertain if the Supreme Court will get this case.

An Inquirer story on the topic is here.

Virginia Gibson prosecuted cases with the U.S. Attorney's Office in Philadelphia and now is a partner at Hogan Lovells, which has pharmaceutical companies as clients. She said the other day that there is not yet a dramatic change in the FDA drug approval process - or what patients can do.

"I think the Second Circuit decision does not change the safety regime that the FDA runs to protect patients," Gibson said. "Patients now, as before the decision in Caronia, can still ask, 'Did the FDA approve this product for what you're prescribing it for or what you're using it for in surgery?' That is still the case."

Gibson suggested the majority tried to carve out space for free speech within FDA guidelines.

"This decision has tried not to touch the FDA regulatory regime," Gibson said. "It may prompt the FDA to issue more guidance on a number of topics."

One key area would be guidance on what sales reps can say when doctors initiate discussions of off-label use of drugs.

"What this decision says is that if a sales person is truthful with the doctor, they can't be prosecuted," Gibson said.

Pharmaceutical reps and companies have been prohibited from marketing drugs for uses other than those shown safe and effective in clinical trials and approved by the FDA. Doctors could prescribe the drugs and patients could take them, but companies could not promote those drugs for those uses.

Pharmaceutical companies and their business backers are eager for more freedom. But the fear of regulators - and Circuit Judge Debra Ann Livingston, who wrote the dissent in the 2-1 decision - is that the remaining constraints that speech must be truthful and not misleading will be lost in the waves of promotion.

Gibson said she is still advising clients to be a careful.

"Our advice to life sciences companies is not that much different than it was before Caronia, which is that the NDA rules apply and that promotional activities including speech must be supported by studies that show safety and efficacy of the product for the intended use, as reflected in the label," Gibson said. "The decision does nothing to prevent the government from prosecuting for misleading speech, misbranding or some kind of omission of important information about safety or efficacy in connection with off-label use of a product."

Because there are limits to the First Amendment.

"Yes," Gibson said. "The First Amendment protects truthful speech and truthful promotion."