FDA Publishes New Guidance on Contents of a Complete Submission for the Evaluation of Proprietary NamesDecember 3, 2008
By Susan J. Matthees –
FDA recently announced the availability of a new draft guidance document on the types of information FDA recommends be included in a complete submission for the evaluation of proprietary names for prescription drug products, biologics, and nonprescription drug products that are the subject of an IND, NDA, ANDA, or BLA. FDA agreed to publish the draft guidance as part of the Agency’s performance goals under PDUFA IV. FDA’s Center for Biologics Evaluation and Research ("CBER”) also published a manual of standard operating procedures and policies specific to CBER-regulated product proprietary names.
FDA’s primary concern for proprietary names for drugs and biologics is safety. An Institute of Medicine (“IOM”) report from 2006 encouraged FDA to address potential safety issues presented by the labeling and nomenclature of drugs and biologics. The IOM and FDA have both expressed concerns about medical errors that could be attributed to sound-alike or look-alike names. Thus, FDA states in the guidance document that the Agency’s “safety review of a proposed proprietary name focuses on the prevention of medication errors,” and that the agency will review names to determine whether they sound or look similar to the names of drugs already being marketed. Additional factors that FDA believes could lead to confusion include the proposed indication, dosage form, route and frequency of administration, strength, unit of measure, dosage units, recommended dose, typical quantity or volume, product packaging, storage conditions, and patient and prescriber population.
The guidance recommends that each submission contain general information, including the primary and an alternate propriety name, the intended pronunciation of the proposed name, the derivation of the name, the intended meaning of any proposed modifiers (e.g., “Lo” or “XR”), and the pharmacological/therapeutic category of the product. All submissions should also contain information about product dispensing and delivery, including the likely environment for dispensing and use and, if applicable, a model and instructions for the product delivery system or device (e.g., a transdermal patch or inhaler) and/or the measuring device for dispensing the product (e.g., a calibrated dosing cup). In addition, FDA “encourages applicants to include any assessments of the proprietary name, packaging, and/or labeling that were conducted or commissioned by the applicant or sponsor,” but the agency will “not consider a submission incomplete” if this information is not provided.
Submissions for products that have proposed labels and labeling should include the proposed labeling “in color and reflecting the presentation that will be used in the marketplace.” In addition, the submission should include the container labels and labeling. The guidance document explains that FDA will evaluate the container labels and labeling and consider the appearance and visibility of critical information, including whether it is prominently displayed, obscured by a logo, or is similar in appearance to the labels or labeling of a different drug or dosage.
If a product does not have proposed labeling, FDA recommends that the submission include the following information: the established name of the drug, prescription status, dosage forms, product strengths, proposed indications for use, routes of administration, usual dosage, frequency of administration, dosing interval, maximum daily dose, dosing in specific populations, instructions for use, storage requirements, and information describing how the product will be supplied and packaged.