In December 2020, the FDA released “Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products Guidance for Industry,” a draft guidance for industry to consider when developing and evaluating a brand name for a nonprescription drug product. To make this information as easy to understand as possible, we’ve broken it out into a Question/Answer format. All answers are taken directly from the guidance document.
Q: What types of products does this guidance cover?
A: This guidance applies to all human nonprescription drug products, including those approved under a new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA), and those that can be marketed without approved applications—often referred to as over-the-counter (OTC) monograph drugs.
Q: What is the purpose of this guidance?
A: This guidance is intended to help sponsors of human nonprescription drug products develop proprietary names. It describes best practices to help minimize proprietary name-related medication errors and otherwise avoid adopting names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. It also describes the FDA’s framework to evaluate proposed proprietary names; this framework is available to sponsors for nonprescription drug products before a product using that proprietary name is marketed.
Q: Is the use of this guidance mandatory?
A: Using the best practice recommendations and other assessment tools addressed in this guidance is not mandatory, and their application does not determine specific outcomes.
Q: In addition to a novel proprietary name, what other types of names are included in the guidance?
A: Section IV describes the FDA’s current thinking on using proprietary names that are already associated with marketed product(s) to introduce a new product. Section V has recommendations for proprietary names for products that change from prescription to nonprescription drug status.
Q: An aspect of prescription proprietary name review is “misbranding” – is this also part of the proprietary name review for nonprescription products?
A: Although this guidance focuses primarily on aspects of proprietary names that can contribute to medication error, it is best to avoid using a proprietary name that could contribute to any violation of the FD&C Act. For example, the FD&C Act states that a drug is misbranded if its labeling is false or misleading in any particular way. A proprietary name, which appears in labeling, could result in misbranding if it is false or misleading, such as making misrepresentations with respect to safety or efficacy.
Q: Can you give an example of how a proprietary name could be considered “misbranded”?
A: A proprietary name may misbrand a product by suggesting that it has some unique effectiveness or composition when it is actually a common substance with easily recognized limitations when the product is listed by its established name.
Q: Can you distinguish between a “brand name extension” and a “family brand”?
A: A “brand name extension” refers to a naming strategy that uses a proprietary name that is already associated with one or more marketed drug products—with or without a modifier—for a product that does not share any active ingredient(s) with the marketed product(s). The FDA advises against using brand name extensions to introduce a new nonprescription drug product.
In this guidance, the FDA uses the term “family branding” to refer to a naming strategy involving the use of the same root proprietary name to identify multiple products that share at least one active ingredient. In this approach, the new product shares a root proprietary name with the original marketed product but adds a distinguishing suffix or modifier to separate the new product from the original.
Q: Do medication errors occur in “family branding”?
A: Family trade names risk medication errors if their modifiers do not adequately differentiate the products. Please refer to the guidance to learn specific questions and consider that affirmative answers generally indicate a lower risk associated with the family branding naming strategy.
Q: Is it fair to say that assessments of a proprietary name are fact-specific?
A: Assessments of a proprietary name are inherently fact-specific, which is why the FDA’s determinations are made on a case-by-case basis, considering every piece of information.
If you have any questions about your next naming assignment for a nonprescription drug product or any concerns regarding this guidance, get in touch with our regulatory experts!