Legally, if a pharmaceutical company wants to market one of its products for “off-label” purposes, it must obtain approval from the US Food and Drug Administration. Recently, however, a Federal judge set a dangerous precedent by ruling that the marketing of drugs for off-label use is “free speech” protected under the First Amendment.
“Off-label” is a phrase referring to the use of a medication for the treatment of a condition other than what it was designed for. A common example is the use of ordinary aspirin as an anti-coagulant in patients at risk for blood clots. Another is the use of the anti-depressant Zoloft for the treatment of sexual dysfunction in men. Legally, a licensed physician may do this without FDA approval, if in his/her trained, scientific, medical judgment, the medication in question is the best choice for treating the patient’s condition. However, until now, drug companies were forbidden by law to market and promote a product for any purpose other than what is stated on the label. A recent federal case has opened a door that may allow drug companies to market their products for any purpose – and prevent the FDA from doing anything about it.
The judge in the case, the Honorable Paul Engelmayer, was nominated by President Obama in March, 2011. At the time, Senator Charles Grassley (R-IA), requested that a hold be placed on the nomination, but no explanation was offered. Engelmayer was appointed in August of that year. Prior to his current appointment, Engelmayer was a partner at the prestigious law firm of Wilmer Hale, and managed the Manhattan office from 2005 onward. Wilmer Hale has represented many major corporate clients in litigation, including medical manufacturer Boston Scientific and pharmaceutical firms Millenium Pharmaceuticals, Pfizer, and Wyeth.
Thanks to Judge Engelmayer, drug company Amarin Pharma can now “engage in truthful and non-misleading speech promoting the off-label use” of its flagship product – regardless of whether or not the drug has been studied for such purposes. In the case of Amarin’s product, Vascepa, the “off-label” use is a matter of degree. The drug has been approved for the treatment of patients with extreme levels of triglycerides, which can lead to heart disease. Amarin Pharma wanted to be able to promote the drug for treating lower levels of triglycerides. Why? An interesting statistic provides some clues: while there are fewer than 4 million Americans with high levels of triglycerides, there are 36 million with lower levels. A daily dose of Vascepa costs approximately $6. Do the math.
When FDA rejected Amarin’s application on the grounds that there was no proof of Vascepa’s effectiveness in treating patients with lower triglyceride levels, Amarin filed suit. Counsel for the plaintiff cited a 2012 criminal case, United States v. Caronia, in which a sales representative for Orphan Medical (now Jazz Pharmaceuticals) was charged with violation of FDA regulations by promoting a medication for off-label purposes. The defendant was found guilty, but when the case went to the Second Circuit Court of Appeals, the 3-judge panel ruled 2-1 that regulations under the Federal Food, Drug and Cosmetic Act (FDCA) “…do not expressly prohibit the ‘promotion’ or ‘marketing’ of drugs for off-label use.”
In her dissent, Judge Debra A. Livingston expressed her concerns that the majority was going down the proverbial slippery slope:
By holding, instead, that Caronia’s conviction must be vacated – and on the theory that whatever the elements of the crime for which he was duly tried, he was in fact convicted for promoting a drug for unapproved uses, in supposed violation of the First Amendment – the majority calls into question the very foundations of our century-old system of drug regulation.
In the present case, counsel for the FDA argued that the Caronia decision was a unique situation, and thus inapplicable to Amarin. Judge Engelmayer disagreed.
It looks like the concerns Judge Livingston expressed in her dissent are coming to pass. Speaking to the Washington Post, New York Law School professor Jacob Sherkow said “this is the first time…that any court – has held in such a clear, full-throated way that off-label marketing is protected by the First Amendment.”
A professor at Harvard Medical School, Dr. Jerry Avon, is also gravely concerned:
I find the decision very troubling. It’s a big push off on to a very steep slippery slope toward removing the government’s authority to limit the claims that drug companies can make about the effectiveness of their products…there’s an enormous amount of statements that drug companies could make about their products that are not overtly fraudulent, but are not the same as a comprehensive review of all the good and bad evidence, that the FDA undertakes when it reviews a drug.
The FDA must appeal Judge Engelmayer’s ruling, as this sets an extremely scary precedent that could easily lead to drugs being prescribed in a manner that have absolutely no therapeutic effect, and actually prove to be very harmful to the patient. The only winners then will be the pharmaceutical companies and the doctors being paid to prescribe the medication.