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Medical Foods |  |
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Rx Status of Medical Foods(MF) Both the Federal Food, Drug, and Cosmetic Act (“FDCA”) and FDA regulations require a medical physician’s supervision of the patient taking medical foods (MF). 21 U.S.C. § 360ee(b)(3); 21 C.F.R. § 101.9(j)(8)(iv)-(v). Specifically, similar to administration and consumption of prescription drug products, patients must use medical foods under a physician’s supervision, and patients should also receive frequent and continual medical supervision on a recurring basis for instructions on the use of the MF. In a simple description of this category, on the FDA’s own website, “A medical food is prescribed by a physician when a patient has special nutrient needs in order to manage a disease or health condition, and the patient is under the physician's ongoing care.” In addition, the FDA states that generally, medical foods are not intended for use by the general public and should not be readily available at drug stores or supermarkets ( FDA, Medical Foods, 1997). This is why many MF companies, including Primus Pharmaceuticals, Inc., only offer their MFs through prescription distribution. Perhaps most importantly, MF companies also comply with prescription status because MF ingredients are specially formulated to be given to diseased populations. Prescription status ensures the required physician supervision. Additionally, over a dozen states have state laws which require prescription status for MFs. Given multiple federal and state requirements, as well as Primus’ desire to market Limbrel as an
ethical medical food based on recognized laboratory and clinical science, a prescription is required to
purchase Limbrel. Finally, federal law requires MFs such as Limbrel to be administered to a diseased patient
population under physician supervision which is the basis of prescription distribution. |
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