In the 1984 movie, “This is Spinal Tap,” one of the characters utters, “It’s such a fine line between clever and stupid.” This classic line comes to mind as we review an issue involving First Databank Inc.’s (FDB’s) decision to include medical foods as over-the-counter drugs in its database.
The matter is interesting, because it highlights the nuanced difference between how the Food and Drug Administration views a product, such as a medical food, that is intended to be used under a doctor’s supervision from how a computer database provider considers such a product, which might not rise to the level of a “prescription” product. This gap in definition has practical implications in a product’s availability.
We will not discuss all of the FDA requirements to sell a medical food. However, in general, medical foods are a subset of foods (and not drugs), intended for the dietary management of a disease or condition for which distinctive nutritional requirements have been established. The Federal Food, Drug, and Cosmetic Act does not require them to be sold pursuant to a prescription, but they are intended to be used under the supervision of a physician.
In 2017, FDB, in its database, decided to categorize medical foods as OTC drugs. FDB is a leading provider of drug and medical device information that helps healthcare professionals make prescribing decisions. The database may also affect whether a product is potentially reimbursable. According to its website, FDB enables its customers “to deliver valuable, useful, and differentiated solutions” and “medical knowledge into actionable, targeted, and effective solutions that help improve patient safety, operational efficiency, and healthcare outcomes.”
As medical foods do not require a prescription, FDB believed its decision was consistent with federal law. In a letter, dated June 29, 2017, FDA wrote FDB, stating:
We believe First Databank has misinterpreted FDA’s response regarding the labeling of medical foods and mistakenly classified all medical food products as over-the-counter (OTC) drugs. We would like to clarify the regulatory classification of these products by providing additional information from FDA’s final guidance on medical foods published on May 13, 2016.
The agency reiterated its position that medical foods are not OTC drugs, require medical supervision, and serve an important public health role. It expressed concern over FDB’s decision. FDB has been sued for its decision, which affects medical foods and certain prenatal vitamins sold by prescription (Exeltis USA Inc. v. First Databank, Inc. – N.D. Cal. Case No. 4:17-cv-04810). Among its many defenses, it claimed that it is not clear that the letter is an official FDA communication. FDB’s motion to dismiss has been denied.
We will follow this issue and provide updates as appropriate.