Originally published September 9 2015
Federal court rules that only drug companies, not supplement companies, have First Amendment rights to truthful speech about health
by J. D. Heyes
(NaturalNews) In a ruling that many holistic healers and homeopathic physicians are likely to find hypocritical, a federal court has handed Big Pharma an unprecedented victory by giving a drug company preliminary approval to market a drug for a condition for which it has yet to be approved by the Food and Drug Administration.
The drug, Vascepa, manufactured by Amarin Pharma, is approved for use in treating very high levels of fats known as triglycerides – over 500 mg per deciliter – in a patient's bloodstream, reports AllGov.com. But Amarin also wanted to promote the medication for use in patients who have "persistently high levels" of triglycerides, from 200 to 499 mg/deciliter.
The FDA denied that request earlier this year over concerns that Vascepa would not help such patients avoid heart attacks or heart disease. That decision led Amarin to file suit in court, claiming its First Amendment rights permitted the company to provide information to physicians and other primary care providers.
Providers have long prescribed medications for "off-label" uses – those not included in a drug's literature or for uses not specifically approved by federal regulators – but the drug companies have traditionally been banned from marketing their products for such off-label uses.
"I find the decision very troubling"However, in recent days U.S. District Judge Paul Engelmayer, who was appointed to the federal bench by President Obama in 2011, ruled to give Amarin preliminary relief, stating the company was permitted to "engage in truthful and non-misleading speech promoting the off-label use of Vascepa."
"This is huge," Jacob Sherkow, an associate professor at New York Law School, told The Washington Post. "There have been other instances a court has held that off-label marketing is protected by the First Amendment, but... this is the first time, I think, that any federal court — that any court — has held in such a clear, full-throated way that off-label marketing is protected by the First Amendment, period, full stop."
AllGov.com reported that the case stemmed from a 2012 New York City federal appeals court ruling finding that a Big Pharma sales rep had not violated FDA regulations by promoting off-label use for a drug to treat narcolepsy, Xyrem, because his speech – as long as he was not being misleading – was protected by the First Amendment. However, in the Amarin case, the FDA said that the Xyrem decision was limited in scope and therefore could not be applied to Vascepa, but Engelmayer disagreed.
However, the parameter of "truthful speech" and a complete statement of facts has proved concerning to some.
"I find the decision very troubling. It's a big push off on to a very slippery slope, a very steep slippery slope toward removing the government's authority to limit the claims that drug companies can make about the effectiveness of their products," Harvard Medical School professor Jerry Avorn told the Post.
"There's an enormous amount, enormous numbers of statements that drug companies could make about their products that are not overtly fraudulent, but are not the same as a comprehensive review of all the good and bad evidence, that the FDA undertakes when it reviews a drug," Avorn added.
Two standardsThe Amarin suit and ruling is narrow, as it involves a company's right to promote just one drug as a treatment for those with high triglycerides – thought to be a factor in heart disease. Nevertheless, the case is being watched closely because it might serve as a vehicle to eventually restrict the FDA's ability to curb off-label promotion of all drugs, the Post noted.
Makers and consumers of health-related supplements, however, are also decrying the ruling, especially companies whose First Amendment rights have been ignored by courts and the FDA in the past.
In December 2012, we reported that a federal appeals court in New York upheld the free speech rights of a pharmaceutical company regarding off-label uses of Xyrem, even as courts and the FDA were gagging makers of natural supplements.
And in March 2013, we reported that the FDA used a truth-in-labeling regulation in issuing warning letters to a pair of supplement companies whose "crime" was nothing more than having customer-related interactions via the Internet.
It appears that there are two separate standards for Big Pharma and holistic and homeopathic healers.
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