Hyperbaric Clinic Reopens Amidst Controversy
Neubauer Hyperbaric Neurologic Center, a controversial clinic, reopened last week after spending nearly two years closed due to an accident involving two of its patients. The accident, which killed a young boy and his grandmother, involved a fire that caused the clinics closure. However, this was not the only trouble for the Fort Lauderdale based clinic.
In 2009, the FDA issued a Warning Letter alleging that the clinic was improperly marketing its hyperbaric chambers. According to the FDA, the clinic was marketing its devices for uses that were not approved by the Agency. Specifically, the FDA claimed that the clinic was promoting treatments for unapproved conditions, including stroke, cerebral palsy, multiple sclerosis, and coma. Although there are several conditions for which hyperbaric treatment is recognized, the FDA took issue with the company claiming to treat unlisted conditions and cited them for promoting “off-label” uses.
The question of whether the Neubauer Clinic may promote off-label uses of hyperbaric oxygen is a complicated one. An off-label use is one other than the approved intended uses that appear in the products labeling. While pharmaceutical companies and the manufacturers of medical devices may be targeted by the FDA for promoting their devices for off-label uses, the FDA ordinarily is not empowered to interfere with the methods that doctors use to treat patients. Rather, the practice of medicine allows doctors to pursue treatment plans that are adapted to the specific patient. Thus, where a doctor promotes various treatments that he or she performs using these devices, the doctor is promoting the practice of medicine and is not subject to FDA interference. While it is unclear whether the FDA will again target the Neubauer Clinic for its marketing materials, the clinic may be protected from FDA enforcement by restricting promotions to the services and procedures its doctors utilize.
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