drug

Federal appeals court says Big Pharma drug reps can legally push unapproved drug uses

Thursday, January 03, 2013 by: Ethan A. Huff, staff writer
Tags: Big Pharma, off-label drugs, free speech

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(NaturalNews) A representative from the Ireland-based biopharmaceutical company Jazz Pharmaceuticals who was previously convicted of illegally marketing prescription drugs for off-label uses has been vindicated after a federal appeals court ruled the illicit marketing to be nothing more than simple "free speech." In a two-to-one decision made by a three-judge panel, it was determined that drug representatives can now freely advise doctors on how to prescribe drugs for unapproved uses, a ruling that could also end up proving beneficial for the natural supplement industry.

According to The New York Times (NYT), the decision from New York's Court of Appeals for the Second Circuit in Manhattan contradicts many years' worth of rulings that resulted in drug companies having to fork over billions of dollars in settlements and penalties to the federal government for what had previously been considered violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Because as we all know, unless the U.S. Food and Drug Administration (FDA) gives its blessing to a particular food or drug, there is no such thing as free speech concerning its health benefits.

But this now appears to have changed, at least for Big Pharma, which will be free to invent new uses for existing drugs, and market them for such uses apart from having to gain proper FDA approval. Doctors have long been free to prescribe drugs for off-label purposes as they see fit, of course, but drug representatives have been prohibited from engaging in this deceptive practice as the FDA considers it to be "misbranding" and "false" advertising. Unless the FDA grants express permission for a specific statement to be made about a food or drug, in other words, then that statement cannot legally be made.

If advising doctors on unapproved drug uses is considered free speech, then so is talking about the health benefits of herbs and supplements

Unless the Supreme Court eventually determines this not-so-surprising federal appeals court decision to be errant, you can expect a whole lot more pharmaceutical drugs to flood the market for all kinds of new conditions, many of which will likely be fabricated to boost profits. But it may not be all bad news; however, as the ruling also sets a new precedent for what defines free speech for the supplement industry as well.

According to the health freedom advocacy group Alliance for Natural Health - USA (ANH-USA), the decision cuts both ways. If pharmaceutical companies can now legally allow their representatives to market drugs for off-label purposes in the name of free speech, then there is no legitimate reason why supplement companies cannot do the same thing with their products in the name of free speech. This means cherry growers, for instance, would now have the freedom to print the health benefits of cherries on product packaging. And supplement manufacturers would be allowed to talk about the health benefits of their products with holistic practitioners and health food stores.

As the old saying goes, "What's good for the goose is good for the gander," meaning the federal government cannot have it both ways when it comes to freedom of speech. Either everyone's freedom of speech is now recognized, or nobody's freedom of speech is recognized. It remains to be seen whether or not the new ruling, if it stands, will be selectively enforced to the benefit of drug companies, or universally enforced to the benefit of everyone.

Sources for this article include:

http://www.nytimes.com

http://www.anh-usa.org

http://www.naturalnews.com/032062_free_speech_science.html

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