Nearly three years since the contemptible and outrageous Citizens United v. FEC ruling by the U.S. Supreme Court – which gave corporations (both foreign and domestic) the right to give unlimited amounts of money to political candidates and campaigns (anonymously) under the guise of “free speech” - a federal court has handed down yet another questionable decision that could affect the rights of patients and the ability of government to hold pharmaceutical corporations accountable.
It's already been called “Citizens United Redux.”
Thanks to the U.S. Second Court of Appeals in Manhattan, marketing prescription drugs for “off-label” use is now considered “free speech” - patient safety concerns be damned. As it was back during the Gilded Age of the late 19th Century, this ruling will once again return us to “an era when people could promote snake oil without restrictions” according to Dr. Richard Deyo of Oregon Health and Sciences University, speaking to a reporter for the Milwaukee Journal-Sentinel.
As the law currently stands, a drug company may not market a drug for any purpose other than those for which it is approved by the Food and Drug Administration. For example, prior to this ruling, Boehringer-Ingelheim (BI) could not legally promote its flagship product Pradaxa for anything other than patients who are elderly, diabetic, suffer from hypertension and/or have a prior history of stroke – and suffer from a specific form of cardiac arrhythmia known as atrial fibrillation (AF). This is exactly the purpose for which the FDA allows BI to market the product – no more and no less. It is true that physicians have increasingly been using Pradaxa for off-label use in recent months, and there is nothing in the law to stop them from doing that – but neither BI nor its sales representatives could legally promote its product for those purposes unless it had been approved for such use by the FDA beforehand.
Now, thanks to the three-judge panel in Manhattan, BI could in theory promote Pradaxa for almost anything from backaches to erectile dysfunction. (This is an extreme example of course, and it is almost certain even BI would not go so far – but I trust the point is made.)
This case started out as a criminal prosecution of a sales representative for Orphan Medical (now part of Jazz Pharmaceutical). The salesman had been promoting the medication to doctors as a treatment for narcolepsy and associated muscular weakness as a treatment for insomnia and fibromyalgia (a hypersensitivity to touch along with fatigue and joint stiffness) – neither of which had FDA approval. Alfred Caronia was prosecuted by the U.S. Department of Justice and convicted in 2008 for violating the Federal Food Drug & Cosmetic Act by “introducing a misbranded drug into interstate commerce,” according to Reuters. Caronia was sentenced to probation for one year, fined $25 and ordered to perform 100 hours of community service.
In appealing his case, Caronia claimed that even though he was a sales representative (there is no readily available information on whether or not he has any medical training or knowledge), he should have the same right as doctors to make off-label recommendations. Not being allowed to do this, he said, was a violation of his rights under the First Amendment.
The three-judge panel decided in favor of Caronia 2 to 1. In his decision, Judge Denny Chin cited a 2011 Supreme Court Case, Sorrell v. IMS Health in which the Roberts Court found that using “speech” - in the case of Sorrell, prescription data – in marketing a drug was “a form of constitutionally protected expression.” Writing the majority opinion, Judge Chin states that “The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good” - while acknowledging that such First Amendment protection does not protect “false or misleading” promotions.
In short, if doctors can discuss and recommend off-label use of a medication, so too can anyone else, regardless of medical training, or lack thereof – provided such discussions are not intentionally misleading.
In her dissenting opinion, Judge Debra Ann Livingston said: “the majority calls into question the very foundations of our century-old system of drug regulation,” adding that when pharmaceutical companies “were allowed to promote F.D.A.-approved drugs for nonapproved uses, they would have little incentive to seek F.D.A. approval for those uses.”
Chances are that the U.S. will appeal the Second Circuit Court's decision to the Supreme Court – but given its current corporatist leanings, it's pretty certain that the decision in favor of Big Pharma will stand.
University of Tulsa law professor Tamara Piety told MedPage Today that the decision in the Caronia case is the fulfillment of Big Pharma's fondest dreams, as the industry has been working to overturn off-label marketing regulations for many years. At the same time, Dr. Andrew Kolodny of New York's Maimonides Medical Center, who has been working to reform the use and abuse of narcotic analgesics among Americans, considers this a major setback. On MedPage, he said:
"A large portion of Americans already are taking drugs with serious
risks that outweigh the benefits...this is going to get much worse. It's
a safe bet that health outcomes will decline from medication side effects,
while spending on prescription drugs will continue to rise."
While this ruling does not apply outside of the Second Circuit and will not necessarily lead to Big Pharma to make changes to their already-aggressive marketing tactics, it may very well hamstring the FDA's efforts to pursue convictions against other corporate offenders in this regard.
Berman, Jacqueline R. “First Amendment Off-Label Promotion Cases Work Their Way Through The Courts.” Journal of Health Care Compliance, March-April 2012.
Fauber, John. “Court: Off-LAbel Drug Marketing is 'Free Speech.'” Milwaukee Journal-Sentinel via MedPage Today. Available at http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/36256.
Gaffney, Alexander. “In Landmark Ruling, Court Sees Off-Label Marketing as Protected Free Speech.” Regulatory Focus, 4 December 2012. Available at http://www.raps.org/focus-online/news/news-article-view/article/2608/in-landmark-ruling-court-sees-off-label-marketing-as-protected-free-speech.aspx.
Stempel, Jonathan. “U.S. Court Voids Drug Rep's Conviction, Cites Free Speech.” Via Reuters, 3 December 2012. Available at http://www.reuters.com/article/2012/12/04/us-offlabel-conviction-idUSBRE8B21DC20121204.
Thomas, Katie. “Ruling Is Victory for Drug Companies in Promoting Medicine for Other Uses.” New York Times, 03 December 2012.