Big Pharma seems to be the winner. But this could open the door for natural health companies to cite truthful science about supplements.
As we have noted before, the FDA thinks that “misbranding” can mean making a completely true statement about a product but without FDA permission. The FDA is definitely not a fan of free speech.
A cherry producer who cites peer-reviewed scientific research from prestigious universities on the health benefits of cherries would, in FDA-speak, have engaged in “false” and actionable “misbranding” which suddenly turns the cherries into what FDA calls “drugs.” It’s because of this “misbranding” threat that supplement producers are not allowed to discuss scientific research on the efficacy of their products.
The FDA also contends that “misbranding” includes marketing or promoting a drug or medical advice for any use other than what the FDA approved it for. In other words, if a drug approved to treat narcolepsy also works as a treatment for insomnia or fibromyalgia (as a drug called Xyrem allegedly does), the drug company and its representatives cannot promote the drug’s off-label uses. Doctors are free to prescribe a drug for any use they wish, but the drug company can’t tell them about such alternative uses.
A former sales rep for the company that made Xyrem was caught on tape doing just that—promoting its off-label uses to doctors. He was convicted by a jury, but the sales rep appealed the conviction, arguing that his right to free speech under the First Amendment was being illegally restricted. And yesterday, a federal Court of Appeals agreed that the ban on so-called off-label marketing violated the sales rep’s freedom of speech. One of the judges wrote, “The government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA [the federal Food, Drug, and Cosmetic Act] for speech promoting the lawful, off-label use of an FDA-approved drug.”
The government is likely to appeal the appellate court ruling, and the case could find its way to the Supreme Court.
While most accounts are chalking this up as just another win for the drug companies, this ruling could open the door for natural health proponents. Considering that the previous understanding was that anyone can speak openly about the truthful-but-non-FDA approved health benefits of a supplement—anyone except the company selling the product and its representatives, that is—this ruling could have huge implications for supplement companies and how they can communicate to practitioners, and perhaps even more broadly, to consumers.
If a drug company sales rep can promote non-FDA-approved uses for drugs, particularly as a means for encouraging doctors to prescribe them to their patients, then might not the same freedom of speech allow supplement companies to tell practitioners about the science behind their product?
We should note that this ruling was on literal speech—what the rep said verbally—and didn’t specifically apply to written materials. But previous free speech rulings interpret the issue more broadly as “freedom of communication.” And even if a court finds it doesn’t apply to written materials, it would likely still apply to what health food store employees can tell you about a supplement—which is, in itself, a huge opening. Maybe the government would have to stop trying to entrap health food store employees.
The Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group representing the drug companies, was of course pleased with the decision. A spokesperson says saying PhRMA “believes that truthful and non-misleading 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.”
Now remove the word “biopharmaceutical” in the above quote and put “supplement” in its place. The sword that is our freedom of speech cuts both ways!
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If “off-label” prescription of drugs can be discussed as free speech than certainly natural products can. However, given that drugs generally have so many more side effects than natural treatments do, it’s high time “off-label” prescription of drugs was banned, the only exception being tightly supervised clinical trials, which would methodically explore their new uses.
It is ridiculous that a natural supplement or food can share what studies have proved!
I do use health food shops for the purchase of my supplements and have noted that a few of them DO have a book which describes the benefits and uses of various of their products. By referring to the “book” the salesperson cannot be held responsible for “prescribing” any particular product. As I am not sure that this literature is free to all health food stores, I would recommend that such a book be made available to all stores and their customers..
The USDA and FDA are in cahoots with Big Pharma. Politicians accept “campaign contributions” from lobbyists for Big Pharma. What a corrupt system we have. Check out: http://www.opensecrets.org and see where the money comes FROM and goes TO in politics! Both parties are guilty for taking campaign contributions and having their “opinions influenced.” We must get ethical, decent, REGULAR PEOPLE into Congress, just as our founding fathers wanted. No more slick lawyers and career politicians who work their back room deals. I guess it’s easier said than done as it costs a fortune to run a political campaign. How sad. Something has to change or our country is a goner…
Lauren, you couldn’t be more right. It’s become so obcene that its estimated that less than 100 people (incl. families) have the real power in the USA. Which leads to a healthcare system thats only goal is to maximize profit. Cross investments in food and drugs ensure that Americans will get sick and stay sick with maximum use of drugs creating maximum profits. Politicians, the FDA, AMA, Hospitals are all bought off through kick backs, incentives, trips, or discounts to maintain profit goals. The last consideration is the health of the individual -get em to the point just before they want to sue you! Sound Crazy? Well I invested in a company that developed a product to save a friend from Idiopathic Pulmonary Disease- the company developed a natural product that qualifies as a nutritional supplement. It saved the friend, extening her life and stopping all the nasty symptoms of that disease. Even though it can extend an IPF patients life and eliminate the symptoms (with documented studies showing those benefits) doctors and patients are unwilling to try the product because the MD community will not even consider the product because it is a supplement NOT A PHARMACEUTICAL DRUG.
One word of a casual (not court-ruling) statement by a drug company cannot be considered an adequate foundation for supplements and natural foods to end-run FDA.
On the contrary, the linking of “bio” with “pharmaceuticals” is scary.
Sounds like Pharma’s planning to replace nutriceuticals with biopharmaceuticals — as soon as FDA removes supplements as Pharma’s only OTC competitor. Remember, the FDA new guidelines against OTC supplements are slated to take effect in the same time frame that many Pharma patents are due to expire and go OTC.
FDA wipes out market access to supplements, then Pharma steps in with “biopharmaceuticals”….It sounds like an opening lead in a crooked card game.
And I don’t see any way to stop them. Congress sure won’t. Or else–in my humble opinion–FDA would have long since been up on charges of malfeasance, misfeasance, misrepresentation of fact, extortion, bribery, subornation, falsification of official documents, and failure to uphold its position of authority and public trust–in my humble opinion.