The Food and Drug Administration (FDA) has finalized guidance for industry describing the agency’s evaluation process for proposed proprietary names for drug and biological products.  The guidance applies to all prescription and nonprescription drug products, innovator and generic drug products, and biological products.  Drug products that may be legally marketed without an approved application are excluded (e.g., OTC drugs legally marketed under a tentative or final monograph).  The two primary goals of FDA’s evaluation of a proposed drug and biological product proprietary name is to mitigate medication errors and to ensure compliance with labeling and promotional requirements.

Safety Evaluation

FDA’s primary safety concern is to ensure a proprietary name does not increase the risk of medication errors.  When evaluating a proposed name, FDA considers the possibilities for misidentification or confusion at all points in U.S. medication-use system, including product procurement, prescribing and ordering, dispensing, administration, and monitoring the effects of the medication.  FDA also uses the product characteristics to anticipate the clinical setting(s) in which the product is likely to be used.  FDA states that “[t]he proposed proprietary name and product characteristics provide the framework for how product variables will interact within the medication-use system and provide the context for the verbal and written communication of the drug name.”

In the guidance, FDA highlights the following product characteristics that could lead to confusion with other products:

• established name of the product
• proposed indication
• dosage form
• route of administration
• strength
• unit of measure
• dosage units
• recommended dose
• typical quantity or volume
• frequency of administration
• product packaging
• storage conditions
• patient population
• prescriber population

Promotional Review

In addition to the safety review, FDA conducts a promotional review of a proposed proprietary name.  FDA considers “whether the name functions to overstate the efficacy, minimize the risk, broaden the indication, or make unsubstantiated superiority claims for the product, or is overly ‘fanciful’ by misleadingly implying unique effectiveness or composition, or is otherwise false or misleading.”

What to Include and When to Submit

A proprietary name submission should include:

• Primary or alternative proposed proprietary name;
• Intended pronunciation of that name;
• Derivation of the name;
• Intended meaning of the name’s modifiers;
• Pharmacologic/therapeutic category;
• Proposed label and labeling, and what should be included when a product does not yet have a proposed label and labeling;
• Information about product dispensing and delivery.

In addition, the submission should include a thorough analysis of the proposed name using multiple methods to identify potential problems, including but not limited to a preliminary screening to identify common errors; a USAN stem search; an orthographic/phonological similarity assessment; drug database searches, computational methods, and/or prescriptions simulation studies to test the likelihood of confusion between the proposed proprietary name and similar names.  FDA also favors the use of the failure modes and effects analysis (FMEA) as a tool to assess medication error safety.

Finally, FDA recommends that proprietary name requests should be submitted as soon as possible but “no earlier than at the end of phase 2 of the IND process.”