In a stunning free-speech decision, the U.S. Court of Appeals for the Second Circuit has overthrown the conviction of a pharmaceutical salesman for promoting the off-label use of a narcolepsy drug, Xyrem, for purposes such as treating chronic fatigue, insomnia and fibromyalgia that have not been approved by the Food and Drug Administration. The government case claimed that the salesman, Alfred Caronia, engaged in the practice while working for Orphan Medical, a company that has been acquired by Dublin-based Jazz Pharmaceuticals.
Caronia was audiotaped discussing the unapproved uses of the drug with a physician in 2005 and was convicted in a jury trial in 2008, Katie Thomas reports in The New York Times. But the implications of yesterday’s ruling go far beyond individual details –- at least in the states covered by the Second Circuit, which are New York, Connecticut and Vermont.
“The government cannot prosecute pharmaceutical manufacturers and their representatives under the F.D.C.A. (the Federal Food, Drug, and Cosmetic Act) for speech promoting the lawful, off-label use of an FDA-approved drug,” according to the 2-1 majority ruling.
GlaxoSmithKline, Pfizer, Abbott Laboratories and Eli Lilly have all made billion-dollar settlements with the government for off-labeling marketing of their products in recent years. The largest settlement, GlaxoSmithKline’s guilty plea and $3 billion settlement for “unlawful promotion of certain prescription drugs, its failure to report certain safety data, and civil liability for alleged false price reporting practices,” was announced by the Department of Justice this July.
And the list of multimillion-dollar settlements includes just about anybody else who is somebody on the pharmaceutical marketing front.
In a dissent to yesterday's decision, Judge Debra Ann Livingston wrote that she would not have upheld the conviction "because the First Amendment has never prohibited the government from using speech as evidence of motive or intent," adding "the majority calls into question the very foundations of our century-old system of drug regulation," Thomas M. Burton reports in the Wall Street Journal.
“Judge Denny Chin, an appointee of President Barack Obama, and Judge Reena Raggi, an appointee of former president George W. Bush, made up the appeals panel's majority,” Burton points out. Livingston was a Bush appointee.
The federal government “had argued that it wasn't prosecuting Mr. Caronia's speech. Instead, it argued, it was using his speech as evidence of selling misbranded drugs, which is a crime,” Burton points out. The FDA and the Justice Department did not have immediate comment on the decision, according to multiple sources.
“Gerald Masoudi, a former chief counsel of the FDA, said the ruling made a distinction between truthful discussion of off-label uses of drugs, many of which are considered legitimate by the medical community, and those that are misleading or false,” writes Thomas. “He noted that ‘anyone on the planet’ could discuss off-label uses of drugs, except for pharmaceutical companies.”
Matthew Bennett, VP of the Pharmaceutical Research and Manufacturers of America, said in a statement that the trade organization was “pleased that the Second Circuit has recognized that the FDA's ability to regulate communication about medicines is circumscribed by the rights protected by the First Amendment.”
If physicians can talk about alternative uses of drugs among themselves, it doesn't seem to make any sense that others cannot," Thomas Liotti, a lawyer for Caronia, tells Reuters’ Jonathan Stempel. The decision "increases the marketability of drugs, and means consumers can be fully informed by sales representatives, manufacturers and their own physicians," Liotti adds.
The full ruling can be accessed here.
“The government now may opt to have the case heard by the entire appeals court, or it could appeal to the Supreme Court. But doing so has its risks, such as the possibility that the Supreme Court might strike down the FDA's marketing restrictions on a nationwide basis,” Burton points out.
In any event, it’s clear that the decision does not represent the final word on the practice, which Big Pharma critics have long charged is seen as “just a cost of doing business” by the industry.
“‘The FDA is not going to roll over and play dead on this,” the Coalition for Healthcare Communication’s John Kamp tells Medical Marketing and Media’s Matthew Arnold. “It's too important to them—it attacks the basis of most promotional regulation by FDA.”
He predicted “a long slog through the courts.” We predict more fodder for commentators of all stripes.