USP Quality Review

No. 68, Issued September 1999

The FDA and Trademarked Names 3,4

Authority over trademark registration is the responsibility of the Patent and Trademark Office (PTO). The FDA, however, is accountable for regulating drug labeling. Therefore, use of a trademarked proprietary name in drug labeling is evaluated under the authority of the FDA. This helps assure public protection from confusing, misleading, and potentially unsafe drug product names. Although the PTO and the FDA often have complementary viewpoints, each authority evaluates significantly different aspects of the trademark. For example:

  • During a drug's review, confidential pharmaceutical information is only available to the FDA. If a product's proposed trademark depicted the drug's indication or dosage in a misleading manner, the PTO would not have this information available to properly evaluate the matter.

  • The PTO examines physical similarity between trademarks in terms of print presentation. Physician handwriting presentation is considered in the FDA evaluation.

As part of a new drug application review, the FDA conducts an evaluation of a proposed product's labeling, including its proprietary name. Until recently, the Labeling and Nomenclature Committee (LNC), a FDA technical committee, provided recommendations to Center for Drug Evaluation and Research (CDER) reviewing divisions on labeling statements and evaluated the adequacy of proposed proprietary and established names.

In October 1998, an existing FDA division expanded to create the Office of Postmarketing Drug Risk Assessment (OPDRA). A mission of this new office is to ensure the safety of marketed drugs. Monitoring and analysis of medication errors is part of the unified postmarketing drug assessment by OPDRA. Implementation of strategies to guarantee seamless product safety from initial evaluation to widespread public use is an important FDA initiative. To this end, OPDRA, in a collaborative effort with New Drug Review divisions, is integrated into preapproval activities. As of August 1999, OPDRA has assumed the responsibility of proprietary name review.

Most proprietary names are evaluated during the new drug application (NDA) stage. A name may be evaluated as early as the investigational new drug stage; however, it will be necessary to reevaluate it at the NDA stage, because other proprietary names may have been approved at this time and will need to be considered. Prior to OPDRA, the evaluation process began with submission of a drug application to the CDER reviewing division with authority over that product. After the chair of the LNC received a request for trademark review by the division, the LNC members discussed the proprietary name during their monthly meeting. Information from the US Pharmacopeia-National Formulary, The USP Dictionary of USAN and International Drug Names, USP Practitioners' Reporting Network, and FDA's MedWatch program were used by the LNC when evaluating proposed proprietary drug name acceptability.

Several of the identified criteria judged critical elements in the LNC proprietary name examination included the following:

  • Sound-alike/look-alike names, including names that have the same doses or dosing schedules.

  • Storage environment of the product, to prevent name confusion between products stored in physical proximity to one another.

  • Names that contain too much of the USAN name or any of the USAN "stem," to discourage subsequent products within a generic class from generating and adopting similar names.

  • Use of the letters W, M, N, C, L, and O. The LNC is concerned that these letters are easily blurred or confused when handwritten.

  • Similar syllables in the first part of a proprietary name; handwriting may tend to trail off in the last part of a name.

Currently OPDRA is in the process of issuing a guidance document that will establish a framework for pre- and postmarketing review of proprietary drug names.