The Food and Drug Administration (FDA) recently invited public comment on plans to allow pharmaceutical companies to reserve proprietary names as early as the end of Phase II trials. According to Regulatory Focus, FDA has posted the Pharmaceutical Research and Manufacturers of America’s (PhRMA) proposal to its public docket, offering the public a glimpse at what could become the basis for the future drug name reservation system. The document can be found here. We previously wrote about FDA guidance and proprietary drug naming here.
Background
Regulatory Focus previously provided a succinct explanation of this drug naming issue. As described in the article, the “proprietary” or “brand” name of a medication, makes it easily identifiable. However, because brand names are generally shorter than the established non-proprietary name for a drug, the potential for confusion can exist. A May 2013 article in the New England Journal of Medicine noted that many drugs approved in the last few years have started with the letters ”X” and “Z,” potentially confusing patients. FDA regulators try to reduce the potential for confusion by approving final trade names submitted by companies, assessing them for similarity to other names.
Additionally, under a May 2014 FDA draft guidance, companies are supposed to subject any proposed name to real-world simulation studies, scenario-based testing, and an analysis of the name using a Phonetic and Orthographic Computer Analysis (POCA) system, which provides computational analysis of drug name similarity.
PhRMA’s Proposal
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 gaining 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As part of the public docket, the FDA said it will enter a draft guidance from PhRMA, which had submitted a proposal based on meetings with the FDA in January 2009. PhRMA submitted a draft guidance entitled “Early Review of Proprietary Names” to FDA for consideration.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.
Voluntary System
PhRMA’s proposed system represents a small temporal change to the current approach. However, it is designed to further FDA’s interest in preventing drug mix-ups and avoiding unnecessary delays in the approval of beneficial new drugs.
The early approval system is designed to improve efficiency and facilitate predictability with regard to approval of proprietary names for new prescription drugs and biological products. It is intended to avoid last minute rejections of proprietary names and speed final approval of safe and effective products. Participation in the early approval system is voluntary, though FDA expects that many applicants will be interested in participating.
Currently, an applicant submits the proposed labeling for a product with its NDA, ANDA, or BLA. If the proposed labeling includes a proprietary name, the applicant must submit the information necessary for FDA to review the name. The applicant may submit up to two proposed proprietary names for review and should indicate which name is its first choice name and which is its second choice name.
If an applicant wishes to participate in the early approval system, it would submit the same information that is submitted under the current system and indicate its desire to participate in the early approval system in the cover letter accompanying its NDA, ANDA, or BLA. By making this request, the applicant agrees to comply with the processes and requirements of the system set forth in this guidance document. Requirements of participation consist of (i) the release of an approved name if the applicable product is not approved within eighteen (18) months of the date the proprietary name is approved, or three (3) years if an extension is granted, and (ii) the publication of the approved name and release date on the FDA website.
If an applicant wishes to participate in both the early approval system and the PDUFA Pilot Project for Proprietary Name Review, the applicant would follow the Pilot Project procedures and simultaneously indicate in writing its desire to participate in the early approval system. If an applicant entered the Pilot Project at the IND phase, it would re-submit the proposed name for final approval under the early approval system when it submits the application.
Additionally, all proprietary names approved under the early approval system would be published on FDA’s website, along with the approval date and the date on which the reservation period is expected to end (as extended, if appropriate). (Unless FDA grants an extension, the reservation period will end on the date 18 months after the name approval date.) FDA will not disclose the name of the applicant, the proposed indications for usage of the applicable product, or any other information about the approved name or applicable product.
If an applicant received tentative approval of its proposed proprietary name under an IND, the applicant would monitor the FDA website for any approved proprietary names that may give rise to a potential conflict with the applicant’s name. The agency will not notify the applicant upon final early approval of a name that, in its view, conflicts with the applicant’s tentatively approved name. The applicant with the tentatively approved name may, however, at any time request a re-evaluation by FDA as to the status of its tentatively approved proprietary name if the applicant believes that a potential conflict with an early approved name may exist.