Earlier this month, the FDA released two documents that will improve aspects of the submission and review processes for generic drug applications, referred to as Abbreviated New Drug Applications (ANDAs). These documents have been created as part of the FDA’s continued implementation of the Drug Competition Action Plan, which aims to encourage increased generic competition in the US.
The first document is draft guidance for industry, titled “Good ANDA Submission Practices”. This guidance document draws attention to some of the recurring deficiencies in ANDA’s that lead to a delay in generic drug approval. One of the main reasons for delay is that applications end up going through multiple cycles of review. In fact, it currently takes an average of four review cycles for an ANDA to reach approval. According to the FDA, in many circumstances this occurs, not because the drug does not meet the agency’s standards, but rather because the application does not contain all the necessary information to demonstrate that it does. Each time the FDA must ask for additional information, a new review cycle is required, which is costly and inefficient. This new guidance document aims to avoid this issue by making sponsors aware of the common deficiencies that they need to avoid, prior to their ANDA submissions.
However, the FDA recognizes that it is not just industry that needs to make changes in order to improve the efficiency of the ANDA review process. The second document released by the FDA is a Manual of Policies and Procedures (MAPP) which formalizes a more streamlined review process for FDA staff. Titled “Good ANDA Assessment Practices”, the document introduces new templates which have been created to improve the efficiency of each stage of the review process. This document intends to make clear to staff that, when an ANDA cannot be approved due to missing information, reviewers should provide sponsors with a detailed explanation of the deficiencies, as well as clear guidance on how to provide the required information. Such measures should ensure that sponsors are fully aware of the problems and understand how to fix them, so that multiple additional review cycles are not required.
The release of these two documents so early on in the new year suggests that the FDA is committed to its promise to make the ongoing efforts on the Drug Competition Action Plan one of its top priorities in 2018. The FDA has announced that these documents will be followed by further initiatives in the coming months to ensure greater generic drug competition.