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Legal Issues: Off-Label Uses

Posted On: May 17, 2018   |   Posted By: Surgical Aesthetics Magazine

Legal Issues: Off-Label Uses

Legal, ethical and informed consent considerations when using products off-label. By Alex R. Thiersch, JD Using pharmaceuticals “off-label”-that is, in ways that are not specified by the United States Food and Drug Administration -is technically legal but somewhat controversial in aesthetic medicine. Decisions regarding off-label usage should be based on current standards of care, the best interest of the patient, and your own training and expertise within the medical field. Following are some important points to consider when examining the off-label use of prescription products in your practice.
The Legality of Off-Label Usage
Medical boards-not the FDA-govern the practice of medicine. So once the FDA approves a product, it is up to the physician to determine how to use that particular drug.
“To be very, very clear, the FDA has no ability-zero ability-to have any control over how a physician practices medicine,” says Bradford Adatto, partner for ByrdAdatto, a Dallas-based healthcare and business law...

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