Improving the Yield on ANDA Submissions: FDA Wants to Hear Industry’s Concerns and Provide Guidance on How to Build a Better ANDA

By Kurt R. Karst – 

In a notice that will appear in the Federal Register later this week, FDA is announcing the establishment of a public docket (Docket No. FDA-2014-N-0032) to receive input and suggestions on ways to improve the quality of ANDAs (original, amendments, and supplements) submitted to the Agency’s Office of Generic Drugs (“OGD”) and on how to best communicate those suggestions to the generic drug industry.  Specifically, FDA is seeking comment “about any difficulties sponsors are having developing and preparing their ANDA submissions that FDA could help address, for example by providing more or better information to industry.”  The notice is the latest move by FDA as OGD transitions into “Super Office” status (see our previous post here) and as the Agency ramps up and braces for Generic Drug User Fee Amendment (“GDUFA”) review and performance metrics beginning in Fiscal Year 2015.  While FDA states in the notice that “[m]ore complete, higher quality ANDA submissions will positively affect the availability of low-cost, high-quality generic drugs to the public,” on a more selfish note, higher quality ANDA submissions may also go a long way to help OGD meet the performance goals agreed to with industry back in 2012 and to avoid multiple review cycles.

Afer providing several examples of common, recurring deficiencies in ANDA submissions (e.g., hot spot problems such as “[s]ignificant flaws in the design of a drug product such that the proposed product will not be able to meet all conditions of use of the reference listed drug”), FDA encourages comment on four 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?

Although FDA’s request may well garner some comments griping about recent changes in the ANDA review process, it seems to be a positive move by the Agency to improve the yield on ANDA approval actions.  And it may just be the tip of the iceburg. . . . we’ve heard rumors that other deliverables are on tap for publication later this year, including a Manual of Policies & Procedures on ANDA prioritization, guidance on the complex amendment tiers described in the GDUFA goals document,  and guidance on Controlled Correspondence (which is also the subject of GDUFA performance metrics).