Even while manufacturers of nutritional supplements remain effectively gagged when it comes to promoting the truthful health benefits of their own products, a recent federal appeals court decision appears to give a free pass to pharmaceutical representatives peddling prescription drugs for “off-label” uses.
Throwing out the previous conviction of Orphan Medical Inc. (now part of JazzPharmaceuticals Plc.) sales representative Alfred Caronia, the 2nd Circuit Court of Appeals in New York found that Caronia’s rights to free speech under the First Amendment had been violated. Caronia had been found guilty in 2008 by a Brooklyn court for improperly promoting the drug Xyrem (an FDA-approved treatment for narcolepsy and daytime sleepiness related to narcolepsy) for other “off-label” uses, including muscle disorders, chronic pain and fatigue. “Off-label” refers to the use of a drug as a treatment for conditions other than those specifically approved by the FDA.
Caronia’s actions were determined to be a violation of the federal Food, Drug & Cosmetic Act, and he was sentenced to one year of probation plus 100 hours of community service. But Caronia appealed that decision, and the appeals court agreed with him, finding that drug companies and sales representatives should have the same rights as doctors do, in promoting FDA-approved drugs for off-label uses.
Writing for the 2-1 majority, Circuit Judge Denny Chin pointed out, “In the fields of medicine and public health, where information can save lives, it only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed.” The ruling cited a 2011 U.S. Supreme Court decision in which speech used for purposes of drug marketing was found to be a protected form of expression under the Constitution.
Decision ignores plight of dietary supplement manufacturers
But though this inalienable rights to free speech and expression may be obvious to some, it apparently is less obvious to others — namely the FDA, which unfairly discriminates against manufacturers of dietary supplements by making it impossible for them to share the health benefits of their products with customers in any reasonable way.
Under current law, any food or dietary supplement purported to offer any kind of health benefit (think those based on ordinary foods too, like cherries and almonds) is immediately reclassified as a “drug,” and therefore subject to the same labor-intensive, multi-million dollar FDA approval process required for prescription pharmaceuticals. (Not that the process does much to protect the public from the dangers of toxic conventional medicine, mind you. But, of course, the government wants its share of the profits, especially as alternative remedies gain in market popularity). And so manufacturers of dietary supplements have little recourse: either keep quite about the health benefits of their products, or be subject to regulatory action. In this way, the FDA is playing terrorist to an entire industry of dietary supplements, which it currently holds hostage — or for ransom, if you will.
Without question, the stark contrast inherent in this criminally dubious double-standard is only further accentuated in light of the recent New York appeals court decision. In his majority statement, Judge Chin went on to say, “The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.”
Exactly. So what will it take to spark skepticism strong enough to lead the country out of this present darkness? So long as manufacturers of dietary supplements are unable to share the benefits of their products, at least as freely as big drug companies are allowed to spread their own claims, the government and the courts of this land have positioned themselves on the inevitably losing side in an ongoing battle between the oppressive forces of greed, and those among us seeking truth, freedom and health.
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