Amarin, free speech and off-label drug promotion
Monday, August 10, 2015
Should representatives of FDA-approved drugs be able to talk to physicians or pharmacists about off-label (i.e. unapproved) uses for their drug? Lately the "legal" answer has seemed to be "absolutely not."
But a recent ruling by a New York federal judge on the side of Amarin Pharmaceuticals, related to alleged off-label promotion of their drug Vascepa, reopens the debate. As John Osborn put it in a recent Forbes article: "The long restrained, tightly controlled communication of scientific and medical information ... has been loosed."
Vascepa is an oral prescription capsule that is FDA approved and indicated only for the treatment of severe hypertriglyceridemia. The recent case involved allegations that the product was being promoted for patients with lower triglycerides who were already on a statin — a use not indicated in the package labeling.
As a pharmacist who often interacts with sales professionals from various drug companies about their products, I would prefer to be able to talk to my rep about anything. If I have a reasonable question about off-label uses, why shouldn't that question get answered?
At the same time, I appreciate the FDA concerns about inappropriate off-label promotion. Anyone who has been around this industry for several years recognizes this has sometimes been a deliberate strategy by unscrupulous leaders in pharma.
For example, I remember the 2004 case against Parke-Davis for inappropriate marketing and promotion of their drug Neurontin, then only approved for epilepsy. That case ended up costing the manufacturer over $400 million — one of the largest settlements in drug litigation history.
Then, there was the 2007 Loprox case in which the new antifungal cream was apparently being touted for diaper rash, when it had not even been approved to use in children under the age of 10.
Pfizer got pummeled in 2009 with settlement charges that exceeded $2 billion over off-label promotion for their drugs Bextra, Zyvox, Geodon and Lyrica. There were six whistleblowers who brought these charges against their former employer, each of which walked away with a share of $102 million in the deal.
We could go on and talk about Celexa, Niaspan, Abilify, Keppra, Lidoderm, etc. The point is drug manufacturers have taken their fair share of punches in the past decade for discussing off-label uses of medications.
But the real issue seems to be about how we draw the line between "promotion" and merely sharing "information." To suggest new, unapproved uses of a drug for which there is little supporting evidence is clearly crossing the line. But to merely answer a question from a physician or pharmacist about off-label uses hardly seems criminal.
Maybe this most recent court ruling suggests the tide is flowing back in the other direction for a change. By supporting Amarin in this case, the court is siding with a previous 2012 ruling related to the drug Xyrem that stated basically the same thing: "We construe the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs."
These are, admittedly, murky waters we tread in. I certainly don't want to unleash a new era of strategically planned, misleading promotions that pressure drug sales teams into pushing unapproved drug uses on every sales call. At the same time I'm glad to see some common-sense free-speech defense coming from the courts.
Yes, the chain seems to be loosened. And I think that is OK, just as long as we don't let go of the chain altogether.
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