Free Speech Is a New Defense for Off-Label Drug Pitches and It’s Having Industry-Wide Ramifications
It’s not unheard of for drugs to be developed for one ailment and be used to treat others. It’s fairly common, after extensive research and testing, for drugs to be used to treat a blanket of issues. However, another approach by big pharma is raising ethical and legal concerns and their new claims that their First Amendment rights of free speech allows them to market off-label purposes for drugs to doctors. An article by Keith A. Spencer in Salon, highlights a recent case that used free speech to defend untested off-label drug claims. The article was originally published on FairWarning and it says the new free speech defense is making waves in Washington.
The Caronia Case
According to Salon, back in 2005, Alfred Caronia met with a doctor as a drug rep for the drug Xyrem. The depressant had been approved by the U.S. Food and Drug Administration to treat patients with the narcolepsy. But Caronia told the doctor, in a recorded conversation, that Xyrem could be used to treat a host of different conditions relating to sleep and muscle issues. However, none of those uses were approved by the FDA and since the street name for Xyrem was the “date rape” drug, the consequences of unregulated use could be serious.Three years later, Caronia was convicted of violating federal law for off-label promotion. But in 2012, a federal appeals court threw out his conviction saying that “the government prosecuted Caronia for mere off-label promotion,” and that is protected commercial speech under free speech as long as it is not false.
Promotion or Crime?
Until these recent free speech developments, the off-label promotion had been considered a crime. The Salon says that FDA has fined drug companies billions for violations hoping to curb misbranding of harmful or deadly side effects. The article quotes Aaron Kesselheim, a physician and lawyer at Harvard University who is considered an expert on drug policy issues. He cites an alarming example of drug company abuses where antipsychotics were given to the elderly with deadly consequences. He also says the promotion of antidepressants to children were linked with suicidal behavior.
As of now, federal prosecutors are still pursuing off-label marketing. When the FDA approves drugs for particular uses, it makes the drug company produce evidence that the drugs are safe and effective in those cases. However, the buck pretty much stops there. The article highlights the FDA’s reluctance to police doctors. The agency says physicians need the flexibility to prescribe what they think works best in each situation. But the information for the multiple uses of the drug needs to come from the doctors themselves or medical journals, not the drug maker. In the past, drug makers have paid around $30 billion in fines for violations of the law.
Hallmarks of a Landmark
Salon points out that there have been two settlements in the past two years that may have been influenced by the Caronia ruling. Plus, there is now one case pending before another federal appeals court that is using the free speech defense. The fear is that the FDA may be curtailed in the fight against drug marketing abuses. Last year the FDA agreed on a settlement with Amarin Corp. The settlement allows the company to “truthfully” promote Vascepa for unapproved uses. The settlement allows Amarin Corp. to police itself in this truthful promotion. Pacira also settled with the FDA using the free speech argument for its pain drug Exparel.
The article says another interesting case is pending in the appeals court in Boston. Two Acclarent executives convicted of off-label marketing are appealing. This is the first off-label promotion/free speech case outside the Second Circuit and it involves a device to clear sinuses.
Another wheel in the cog is that Congress appears to be showing a willingness to loosen restrictions. The Salon article says a “House Subcommittee on Health held a hearing to review two bills relating to the promotion of off-label uses of drugs and devices.” In a memo obtained and used in the article, the “subcommittee said that proposed legislation would clarify what drug makers can say without fear of retribution.”
The Caronia case is still rippling across the courts, but it appears it will have a lasting impact on the way big pharma can market its drug uses. Or least give them a free speech defense when called to account.
Jeffrey A. Newman represents whistleblowers: 1-800-682-7157