U.S. Barred From Prosecuting Off-Label Drug Sales


Pharmaceutical sales reps, and by extension the companies they work for, are protected by their right to free speech even when on the job, according to a 2-1 decision by the U.S. Court of Appeals in New York. “The majority calls into question the very foundations of our century-old system of drug regulation” said Judge Debra Ann Livingston in her dissent, a system “developed to protect consumers from misleading and unsubstantiated claims about drugs’ safety and efficacy…”

Article → Of Further Interest:
Pharma can’t be prosecuted for off-label marketing, court rules

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Kermit Cole
Kermit Cole, MFT, founding editor of Mad in America, works in Santa Fe, New Mexico as a couples and family therapist. Inspired by Open Dialogue, he works as part of a team and consults with couples and families that have members identified as patients. His work in residential treatment — largely with severely traumatized and/or "psychotic" clients — led to an appreciation of the power and beauty of systemic philosophy and practice, as the alternative to the prevailing focus on individual pathology. A former film-maker, he has undergraduate and master's degrees in psychology from Harvard University, as well as an MFT degree from the Council for Relationships in Philadelphia. He is a doctoral candidate with the Taos Institute and the Free University of Brussels. You can reach him at [email protected].


  1. I’m confused. Are they saying that illegally promoting the drugs for unapproved uses is free speech? And since when has it been O.K. for 3 people to decide important matters? That’s damn near a dictatorship. How hard could it be for mega billion dollar companies to corrupt just a few people?

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  2. The ruling was worded as free speech for the “legal off label marketing of FDA-approved drugs”.

    I think that this is huge. It encourages broad and irresponsible promotion of destructive, disabling yet profitable drugs. Pharma has everybody in their pocket over in Washington (not to mention, big media, as well).

    Forewarned is forearmed I suppose, but who is going to fight the fraud beyond Whitaker? Can’t we scare up a few more journalists with some integrity and an eye for an untold story?

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  3. Thank you for posting this. It’s a really important discussion but very complicated. You almost need a law degree just to get what the ruling is and I have no idea how we could reverse this action. Maybe with a class action suit from people who have been harmed by off label use?

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  4. It sounds like we need a change in the law that makes such prosecutions viable. It’s related to the “corporations as persons” concept that we saw in the Citizens United ruling allowing unrestricted funding of political campaigns. We need a constitutional amendment clarifying that corporations do not enjoy the same constitutional free speech protections as individuals. A Corporation is NOT a person!

    This is VERY scary!

    —- Steve

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