Off-label drug marketing OK d by Federal Court

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A federal appeals court in New York ruled this week that off-label drug promotion and marketing is free speech protected by the First Amendment. If the ruling stands, pharmaceutical companies will be able to legally market drugs for off-label conditions that they have studied but have not been approved by the Food and Drug Administration. This has the potential to change the face of marketing of prescription drugs in America, and may affect everything from patient care to TV advertising.

Reactions to this decision have been intense, but mixed. Richard Deyo, MD, a professor of family medicine at Oregon Health and Science University, says, This risks taking us back to an era when people could promote snake oil without restrictions a situation I would hate to see. And Andrew Kolodny, MD, a New York psychiatrist, says that 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.

But Pharmaceutical and Research Manufacturers of America spokesman Matthew Bennet disagrees. "PhRMA believes that truthful and nonmisleading communication between biopharmaceutical companies and healthcare professionals is good for patients, because it facilitates the exchange of up-to-date and scientifically accurate information about new treatments," and this ruling will allow that.

ACSH s Dr. Josh Bloom thinks that Deyo s assertions are ridiculous. Back to an era when people could promote snake oil without restrictions ? Is he kidding? These are approved drugs, not snake oil, and the practice of using off-label drugs has been going on for many years. This is one of the dumbest comments I ve read in quite a while.

Dr. Bloom has written an op-ed piece on this subject. And it s even more timely than it seemed, since we re sure most of you have heard about Duchess Kate s bout of hyperemesis gravidarum (severe morning sickness with intractable vomiting.) The drug used to treat this condition, Zofran, is being used off-label it was originally approved to treat nausea and vomiting associated with cancer chemotherapy.