Two New Developments for Proprietary Name ReviewOctober 6, 2009
By Susan J. Matthees –
FDA recently announced two new developments related to its review of proprietary name submissions. First, FDA announced the availability of a new manual of policies and procedures (“MAPP”), MAPP 6720.2: Procedures for Handling Requests for Proprietary Name Review, that details the Center for Drug Evaluation and Research’s (“CDER’s”) procedures for handling request for proprietary name reviews. Second, after the release of the new MAPP, FDA announced a pilot program to evaluate proposed proprietary name submissions.
The new MAPP fulfills CDER’s PDUFA IV goal to develop a MAPP by the end of fiscal year 2009, and comes almost a year after FDA announced the availability of a guidance document on contents of a complete submission for evaluation of proprietary names and the Center for Biologics Evaluation and Research (“CBER’s”) MAPP on proprietary name review.
The CDER MAPP applies to requests for proprietary name review that are submitted to INDs, NDAs, efficacy supplements, labeling supplements, and therapeutic biological products (“BLAs”) regulated by CDER. The MAPP will also apply to requests for review for ANDAs, although ANDAs are not subject to PDUFA. Accordingly, the MAPP provides the review procedures to be used by CDER’s, the Office of Surveillance and Epidemiology (“OSE”), including the Division of Medication Error Prevention and Analysis (DMEPA), the Office of New Drugs (“OND”), and the Division of Drug Marketing, Advertising, and Communication (“DDMAC”). The MAPP will also be followed by the Office of Generic Drugs (“OGD”) for the review of ANDA proprietary name submissions.
Pursuant to the MAPP, FDA must review a request for a proposed proprietary name during the IND phase within 180 days of receiving the request. If the name is submitted with an NDA or as part of a supplemental application, FDA must complete a review within 90 days of receiving the request.
Interestingly, the MAPP states that FDA has the authority to require a prior approval supplement for a name and that any addition or change to the proprietary name must be submitted as a prior approval supplement because of the potential for safety concerns. This seems to be a higher standard for a prior approval supplement than what is set forth in existing regulations and we are interested in seeing whether the statement will be challenged.
The pilot program to evaluate proposed proprietary name submissions is a voluntary 2-year program that FDA states “will enable participating pharmaceutical firms to evaluate proposed proprietary names and submit the data generated for those evaluations to FDA for review.” FDA began accepting requests to register for the program, which is available for submissions to CDER and CBER, on October 1.
The pilot program fulfills FDA’s obligations under PDUFA IV to implement a pilot program that allows pharmaceutical firms to evaluate their own proposed proprietary names and submit data from those evaluations to FDA for review. FDA published a concept paper on the pilot program last October.
In order to participate in the program, interested parties must contact the appropriate FDA center (CDER or CBER) to register and provide the approximate month for the intended submission. FDA states that it “will strive to include a cross-section of applicants that represent large, medium, and small companies.” Accordingly, FDA will make a determination whether it has space for an applicant during the requested time period. If there is space for the application, FDA will confirm the applicant’s registration via email.
At the end of the 2-year program, FDA will evaluate the program to determine whether applicants should perform their own proprietary name analysis. FDA promises to hold a meeting to discuss the results of the program and publish a draft guidance describing the best test methods for proprietary name evaluation.