by Long Island Attorney Paul A. Lauto, Esq.
Alfred Caronia, a big pharma sales representative, was previously found by a lower court to have violated the federal Food and Drug Cosmetic Act in his off label promotion of the drug Xyrem. Although the drug Xyrem is approved by the FDA for narcolepsy, Caronia promoted the drug for off label uses including muscle disorders, fatigue and chronic pain. As a result of his unlawful promotion, Caronia was sentenced to one year probation and 100 hours of community service.
Upon appeal, the 2nd circuit Court of Appeals in NY reversed the lower court decision. In explaining the basis for the reversal Judge Chin stated that, "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." Judge Chin continued to state, "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."
Unfortunately, the court appears to be selectively enforcing First Amendment rights to prescription drug manufacturers, as the same rights do not apply to natural supplement manufacturers. Under current law any supplement or even food that purports to have any kind of health benefit, is reclassified as a "drug". In accordance with such reclassification, that supplement or food becomes subject to the same multi-million dollar FDA approval process required for prescription drugs. Accordingly, food and supplement manufacturers have little recourse except to remain silent as to the health benefits of their product.
Inarguably, improper usage or overuse of natural supplements, as with prescription drugs, may be dangerous to your health. However, when our founding fathers crafted the First Amendment, their intent and purpose behind the guarantee of free speech was that it was to be applied equally. If the equal application of free speech to food and supplement manufacturers was not an issue before Judge Chin to rule upon in the within case, then that omission is one than should be rectified by the courts in a separate case. Unfortunately, to do so would be to go against Big Pharma's grain and therefore is unlikely to happen anytime soon.
Long Island Lawyer
Paul A. Lauto, Esq.
Alfred Caronia, a big pharma sales representative, was previously found by a lower court to have violated the federal Food and Drug Cosmetic Act in his off label promotion of the drug Xyrem. Although the drug Xyrem is approved by the FDA for narcolepsy, Caronia promoted the drug for off label uses including muscle disorders, fatigue and chronic pain. As a result of his unlawful promotion, Caronia was sentenced to one year probation and 100 hours of community service.
Upon appeal, the 2nd circuit Court of Appeals in NY reversed the lower court decision. In explaining the basis for the reversal Judge Chin stated that, "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." Judge Chin continued to state, "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."
Unfortunately, the court appears to be selectively enforcing First Amendment rights to prescription drug manufacturers, as the same rights do not apply to natural supplement manufacturers. Under current law any supplement or even food that purports to have any kind of health benefit, is reclassified as a "drug". In accordance with such reclassification, that supplement or food becomes subject to the same multi-million dollar FDA approval process required for prescription drugs. Accordingly, food and supplement manufacturers have little recourse except to remain silent as to the health benefits of their product.
Inarguably, improper usage or overuse of natural supplements, as with prescription drugs, may be dangerous to your health. However, when our founding fathers crafted the First Amendment, their intent and purpose behind the guarantee of free speech was that it was to be applied equally. If the equal application of free speech to food and supplement manufacturers was not an issue before Judge Chin to rule upon in the within case, then that omission is one than should be rectified by the courts in a separate case. Unfortunately, to do so would be to go against Big Pharma's grain and therefore is unlikely to happen anytime soon.
Long Island Lawyer
Paul A. Lauto, Esq.
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