In a Federal Register Notice to publish on January 23, 2014, OGD is seeking comments and suggestions on how to improve the quality of submitted ANDAs and associated amendments to those applications. In addition, OGD is asking about what specific difficulties firms are having when preparing their ANDAs, so that FDA might help “provid[e] more or better information” to industry.
FDA is taking this action in an attempt to help speed generic applications to market by receiving higher quality and complete applications at the time of initial submission. The Agency notes that the Generic Drug User Fee Act (GDUFA) places definitive metrics on OGD relative to review of ANDAs, but FDA says they are being “hampered by the quality of ANDA submissions”.
While the Agency is seeking suggestions, they also want ideas on how best the Agency can share its suggestions with the industry. FDA will receive comments for 60 days after the Notice publlishes into docket FDA-2014-N-0032.
The Notice outlines some common types of deficiencies in CMC, bioequivalence, sterility assurance, Form 356h issues, and DMFs, as well as “fatal flaws” found in the ANDA . FDA is asking that comments and suggestions address one or more of the following types of questions:
1. What aspects of the ANDA application process are confusing or not well defined?
2. What problems do ANDA applicants encounter when developing a submission that FDA could help address?
3. Prior to GDUFA, were ANDA submissions consistently slowed or stalled at certain recurring review points post-filing? If so, why?
4. How should FDA share suggestions for improving ANDA submissions with industry, beyond issuing regulatory guidance?
One of the issues that OGD has yet to address in its review process (and not just since GDUFA, but since the passage of the Hatch-Waxman Act) is the issue of consistency of OGD’s review. While industry’s ANDAs may need to be of better quality, one of the reasons that FDA is having trouble getting quality applications is that, historically, ANDA applicants have tried to make changes to other filings based on past experience in response to the types of deficiencies received from OGD on other applications. However, depending on the reviewer or the specific Division, reviews have historically been quite disparate. Many firms believe they are constantly trying to hit a moving target. While the industry does share some of the blame for the quality in its applications, the Agency also needs to accept some of that responsibility relative to the consistency of its reviews as it is from these reviews that the industry learns what the Agency’s expectations are. There are a number of examples we have seen where similar applications from the same company have received either very different Complete Response Letters (CRLs)/deficiency letters where the issues in the application were essentially the same, or where one ANDA receives a Refuse-to-Receive letter, where another very similar application for a different strength but from the same company (special filing consideration) was received for review.
Please be certain to provide comments to this docket with your suggestions as this is one area that may provide some transparency and insight into issues that are causing problems on both the industry and Agency sides of the review and approval process.