The US Food and Drug Administration (FDA) is establishing a public docket to discuss issues related to reserving proprietary names for drug products. During the negotiations for the 2007 reauthorization of the Prescription Drug User Fee Amendments Act (PDUFA IV), the FDA agreed to several performance goals related to the review of drug and biological product proprietary names to reduce medication errors. Among those goals, the FDA and the industry expressed an interest in exploring the possibility of “reserving” proprietary names for companies once the names have been tentatively accepted by the agency. Accordingly, FDA is initiating a public process to discuss issues around reserving proprietary names. The public comment period is open until October 27, 2014.
As part of the PDUFA IV process, the FDA agreed to a process and timelines for notifying applicants of the tentative acceptance or nonacceptance of a proposed proprietary name. These proprietary name review performance goals and timelines are separate from the timelines for approval of underlying new drug applications and biologics license applications. These goals and timelines also permit sponsors or applicants to obtain such a notification as early as during the investigational new drug stage, any time after the completion of a Phase II study.
Stakeholders, however, have indicated that the existing process for reviewing proprietary names does not provide applicants with sufficient certainty, prior to approval of their application, that a proposed proprietary name will be included in approved drug labeling. Some members of industry have suggested that they remain particularly concerned that a “tentatively acceptable” name may be subsequently rejected because of the intervening approval of another drug whose application was pending, but not public, at the same time as their own. In the documentation regarding its pilot program for proprietary name review, FDA acknowledged that it may be unable to disclose certain information to an applicant in connection with a proprietary name review.
In seeking public comment, the FDA said it was particularly interested in knowing if there were examples of drug market launches being delayed or of drugs being launched without a proprietary name because the FDA's determination that a proposed proprietary name would not be acceptable came too close to the date of product approval. FDA said it was also interested in gain furthering suggestions for potential approaches for reserving proprietary names that would create more certainty for applicants than the current “tentative acceptance” process.
As part of the public docket, the FDA said it will enter a draft guidance from the Pharmaceutical Research and Manufacturers of America (PhRMA), which had submitted a proposal based from meetings with the FDA in January 2009. PhRMA submitted a draft guidance entitled “Early Review of Proprietary Names” to FDA for consideration. FDA placed PhRMA's proposed guidance document in the newly established public docket for information pertaining to a possible name reserve program, so that it is available to all interested members of the public.
Source: Federal Register (July 28, 2014)