Today's Wall Street Journal reports:
Free speech in prescription drug marketing will get a fresh look on Thursday when a federal appeals court in San Francisco considers whether a biotech executive committed fraud in touting a lung-disease drug.
FormerInc. Chief Executive W. Scott Harkonen is appealing a 2009 wire fraud conviction for a news release that trumpeted the purported survival benefits of Actimmune, made to treat fatal lung disease. His attorneys contend the conviction should be reversed because the release "expressed a scientific view" that is protected by First Amendment free-speech rights.
The government, which indicted Dr. Harkonen in 2008, maintains in its brief that the First Amendment doesn't bar a "criminal prosecution of false statements with an intent to defraud" just because they "concern scientific matters."
The Ninth Circuit U.S. Court of Appeals hearing is the second legal challenge this week that could change the scope of Food and Drug Administration restrictions on off-label marketing. On Monday, the Second Circuit in New York threw out the conviction of a pharmaceutical salesman for marketing drugs for uses unapproved by the FDA on the grounds that his actions involved free-speech rights.
Potentially jeopardized in both cases is a set of FDA regulations prohibiting drug companies from off-label marketing, or marketing a medicine for purposes not approved by the agency. Also threatened is the government's extracting of billion-dollar settlements from companies that do just that.
"It is important to the FDA to preserve the notion that you can't sell a medicine for an unapproved purpose," said Washington attorney Bert W. Rein of Wiley Rein, who has represented an opponent of FDA marketing rules. "That agency is so vested in its regulatory scheme that they will fight."
The pharmaceutical industry has argued it should have the legal right to make truthful statements about its drugs, even when the statements aren't related to an FDA-approved use. The drug-industry trade association, Pharmaceutical Research and Manufacturers of America, filed a friend-of-the-court brief on Dr. Harkonen's side. It called the case "an unprecedented prosecution of a pharmaceutical executive for expressing in a news release his scientific opinion about the development of a drug to treat disease." . . .
FDA officials say their off-label rules are designed to protect the public. They note, for instance, that two heart-rhythm drugs in the 1980s were prescribed off-label for minor rhythm problems and turned out to be linked to a more than doubled death rate. Dr. Robert Temple, deputy director for clinical science at the FDA's drug center, said in an earlier case challenging FDA rules that "the risk to the public from unproven uses of drugs is real and substantial." . . .
Richard Samp, chief counsel of the conservative-leaning Washington Legal Foundation, said that regardless of the ultimate outcomes of such drug-marketing cases, he expects the government to continue challenging off-label marketing by big companies. Defendants often settle to avoid the price of litigation and the potential of being barred from future government contracts.
"The primary reason the FDA can enforce its view of the law is that most of the players won't challenge that view," he said.