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# GSK Wants Changes to OTC Drug Naming Guidance
- URL: https://www.fdaweb.com/gsk-wants-changes-to-otc-drug-naming-guidance/
- Published: 2021-02-23T12:00:00.000Z
- Updated: 2026-09-14T16:47:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148728

GlaxoSmithKline Consumer Healthcare says that a 12/9/20 FDA draft guidance, *Best Practices in Developing Proprietary Names for Human Non-prescription Drug Products*, does not reflect best practice as it pertains to over-the-counter (OTC) drugs and that implementation of the guidance as written “could significantly limit our ability to introduce future innovation to existing brands, both within the U.S. and globally as markets worldwide may be influenced by U.S. FDA policies.” The firm’s 2/8 comment [letter](https://downloads.regulations.gov/FDA-2020-D-0770-0004/attachment%5F1.pdf?ref=fdaweb.com) says GSK appreciates that FDA issued a separate guidance for the proprietary naming of nonprescription drugs, but several guidance elements reflect a restrictive view of brand name selection. For example, it says, the guidance: 

- provides similar treatment of Rx and OTC drugs, despite differential risk profiles;
- does not reflect risk-based decision-making that considers the consequences of potential name confusion;
- focuses on the name in isolation and does not consider the full context of the label or potential risk minimization measures;
- emphasizes the role of the healthcare professional in the assessment process versus the consumer as the target decision-maker; and
- does not reflect unique OTC label studies as a relevant assessment tool.

GSK asks that the final guidance reflect a process and assessment standard that is unique and relevant to OTCs in terms of: 

- different naming review standards for prescription and non-prescription products;
- naming decisions that are data-driven and determined case-by-case;
- consideration of elements beyond the brand name that influence consumer choice such as treatment category, setting, full package/label, and potential mitigation measures;
- risk-based decision-making that considers consequences of brand name confusion; and
- where warranted, implementation of testing approaches that are targeted to the consumer as the primary decision-maker using methodologies currently in place for developing and testing OTC labels.