FDA has announced the availability of another draft guidance for industry entitled, Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process. The draft guidance is part of FDA’s continued support of the Drug Competition Action Plan and to encourage the generic industry to take advantage of the USP’s Pending Monograph Process that was initiated in 2015.
The Pending Monograph process allows for development of monographs or revisions to articles awaiting approval by FDA. This process can be used if USP does not yet have a monograph for a drug, or if there is an existing monograph with requirements that are not met by a potential product under review by FDA. These proposed monographs or revisions remain in an unofficial status until FDA approval of the application. You can find the details of the process in the USP’s Pending Monographs Guideline (November 30, 2017).
The draft guidance encourages the applicants and provides more details of the process as well FDA’s own perspective. For example, the guidance recommends that applicants initiate the USP-PMP concurrent with submission of the application to FDA. Also, the intent to initiate or ongoing USP-PMP process should be stated in the cover letter of the application.
Harmonization of the standards had always been an issue for all the stakeholders. While pending standards have been in vogue for some time now, the formal acknowledgement of the issue by FDA and the development of the USP-PMP process provided an option to allow applications to be approved earlier. With the complexity in drug formulations ever increasing, this may be a good way to encourage innovation as sponsors will dare to step out of the familiar space of USP monographs, when it comes to designing products. Also, the simultaneous evaluation by the two major organizations could help in quick acceptance of science-based criteria and availability of generics in the US market.