Posted 06 April 2016
By Zachary Brennan
The final guidance from the US Food and Drug Administration is part of a host of proprietary name evaluation measures from the reauthorization of the Prescription Drug User Fee Act and aims to help reduce medication errors.
Although prescription drug names can sound funny or awkward, health care providers often rely on the proprietary name as the critical identifier of the appropriate therapy in a market of tens of thousands of products. Product names that look or sound alike can lead to medication errors and potential harm to patients, particularly if the wrong name leads to prescribing the wrong product, dispensing and/or administering the wrong product, or dispensing a product incorrectly.
As part of its premarket review of drug, biologic and generic drug applications, FDA evaluates both safety and promotional aspects of the product’s proposed proprietary name.
In its finalized guidance, FDA offers recommendations on what sponsors or applicants should include in their submissions to ensure that the agency can review the proprietary name appropriately.
Those submissions 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.
“FDA generally encourages applicants and sponsors to submit their requests for FDA review of proposed proprietary names as soon as they have the recommended supporting information as described in this guidance,” according to the guidance. “However, as explained in section II.E, if the request is submitted at the IND stage, it should be done no earlier than at the end of phase 2 of the IND process.”
Contents of a Complete Submission for the Evaluation of Proprietary Names Guidance for Industry