In September 2007, the Prescription Drug User Fee Act (PDUFA IV) was reauthorized and expanded, broadening and strengthening FDA’s drug safety program. As part of PDUFA’s reauthorization, the Agency established a number of performance goals related to the implementation of user fees, which FDA stated would be used to reduce medication errors. More specifically, as one of its goals FDA agreed to publish a guidance document “on the contents of a complete submission package for a proposed proprietary name for a drug or biological product.”
In 2000, the Institute of Medicine (IOM) published a report, entitled “To Err is Human: Building a Safer Health System,” which named medical errors as the eighth leading cause of death in the United States. Furthermore, the report also stated that among the most common medical errors are medication errors, which are attributed to roughly 7,000 deaths each year. In response to these numbers, “the IOM recommended that FDA:
The IOM published a second report in 2006, entitled “Preventing Medication Errors,” which listed labeling and packaging issues as the cause of 33% of all medication errors, and 30% of all deaths resulting from medication errors. In this report, the IOM “urged FDA to incorporate better principles of cognitive and human factors engineering to address issues concerning information presentation in labeling and nomenclature.”
Proprietary Name Confusion & Medication Errors
In the US, physicians use the proprietary name as a critical identifier in selecting the appropriate therapy. As such, it is absolutely crucial that the product’s name can be interpreted accurately to ensure that patients receive the correct product.
When product names look and/or sound alike, the chances of medication error occurring increases significantly among prescription and nonprescription, or over-the-counter (OTC), products. Because of this, FDA evaluates both the safety and promotional aspects of a product’s proposed proprietary name as a part of its premarket review process.
“FDA’s safety review of a proposed proprietary name involves multiple methods to identify potentially problematic proprietary names, including the following:
The failure modes and effect analysis (FMEA), which “is a systematic tool for evaluating a process and identifying where and how it might fail. Institute for Healthcare Improvement (IHI),” is one of the tools used to conduct the medication error safety assessment of a product’s proposed proprietary name. After any potential look-alike and/or sound-alike names have been identified, FDA performs a FMEA of these names in order to determine where failures could occur with the proposed product.
To fully assess the safety of a proposed proprietary name, it is important to take product characteristics into consideration as well. According to the guidance, “product characteristics can act together with the orthographic and phonologic attributes of the proposed proprietary name (1) to increase the risk of confusion when there is an overlap in product characteristics among two or more products, or (2) in some instances, to decrease the risk of confusion by helping to differentiate products through dissimilarity.”
FDA also conducts a promotional review of proposed proprietary names, which “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.”
On April 6, 2016, FDA published a final guidance entitled “Contents of a Complete Submission for the Evaluation of Proprietary Names,” which is aimed at reducing medication errors.
PDUFA IV Goal Dates
According to the PDUFA IV performance goals, the review clock for the evaluation of a proposed proprietary name begins when the submission is complete. If the submission is not complete, the guidance states that the FDA will notify the sponsor in writing. Once the submission is complete, the review clock is started and is based on the FDA’s stated date of receipt. According to the Agency’s review performance goals, FDA will complete its review and communicate a tentative acceptance or non-acceptance about the name within:
FDA notes that these performance goals do not apply proposed proprietary names submitted under an abbreviated new drug application (ANDA).
When & Where to Send Submissions
According to the guidance, “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.” The request for a proposed name review should be sent as a separate submission to a pending NDA, BLA, or ANDA or supplement; if such an application is not available yet, the request should be submitted to an active IND.
Requests may be submitted in paper or electronic format. Applicants sending submissions in paper format must send “three copies of the submission the to the same address as the original application with which the proprietary name is associated.”
For additional information, including where to send submissions, view the FDA’s full guidance.
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Do you want more information on FDA’s guidance? Part two has everything you need to know about the contents of a complete submission and is coming soon.
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