Draft Guidance and a MaPP to Help Firms and Reviewers Get It Right the First Time (or Second Time)

Today, the FDA issued a draft guidance entitled “Good ANDA Submission Practices” (here) along with a new Manual of Policy and Procedure (MaPPs) 5241.3, entitled “Good ANDA Assessment Practices: Manual of Policies and Procedures.” These establish good ANDA assessment practices for the Office of Generic Drugs and the Office of Pharmaceutical Quality to increase their operational efficiency and effectiveness. (here ).

Regarding the draft guidance, the FDA says:

“This draft guidance is intended to assist applicants preparing to submit ANDAs to FDA. It highlights common, recurring deficiencies that may lead to a delay in the approval of an ANDA. This draft guidance also makes recommendations to applicants on how to avoid these deficiencies so that applicants can submit ANDAs that may be approved in the first review cycle. This draft guidance has been developed as part of FDA’s “Drug Competition Action Plan,” which, in coordination with the Generic Drug User Fee Amendments (GDUFA I and II) (Pub. L. 112-144 and Pub. L. 115-52, respectively) and other FDA activities, is expected to increase competition in the market for prescription drugs, facilitate entry of high quality and affordable generic drugs, and improve public health.”

The MaPP, according to the Agency, “establishes good ANDA assessment practices for the Office of Generic Drugs and the Office of Pharmaceutical Quality to increase their operational efficiency and effectiveness.”

These two documents have been developed based upon feedback from industry during the GDUFA I term and as part of the FDA’s Drug Competition Action Plan which, along with GDUFA II and other Agency initiatives, are designed to bring generic products to market in a more expeditious manner.

The industry guidance document explores common deficiencies and how to respond to them in the following categories:

  • Patent and exclusivity deficiencies
  • Labeling deficiencies
  • Product quality deficiencies and.
  • Bioequivalence deficiencies

While the guidance does restate many of the common deficiencies that OGD has previously identified as issues that tend to create additional review cycles, they also provide additional transparency as to what OGD is actually looking for, which may make responding to the deficiencies easier or help to avoid them altogether.

The MaPP speaks to an age-old problem relative to “the nice-to-know versus the need-to-know” for approval that has been brought up by industry for years. As FDA states in the MaPP:

“Over the past several decades, ANDA review customs have evolved, and the quantity of documentation of FDA’s ANDA review has increased. During this time, supervisor expectations concerning review documentation occasionally varied within and across disciplines. For instance, reviewers sometimes evaluated ANDAs beyond what was necessary to ensure that the ANDA met the regulatory requirements for approval, worked to remediate and re-assemble poorly organized ANDAs, or generated elaborate work papers.

OGD and OPQ’s consistent and targeted focus should continue to be on evaluating whether ANDAs meet the regulatory requirements for approval. To reinforce the policy and procedural changes set forth in this MAPP, going forward, OGD and OPQ will use the term assessment in place of review. Assessment means the process of both evaluating and analyzing submitted data and information to determine whether the application meets the requirements for approval and documenting that determination.”

The document goes on to discuss the need for reviewers to:

  • Not only utilize standard and proven templates in their assessment and determine when an ANDA meets the regulatory requirements but also to explain why there are deficiencies and how to define what is needed to resolve them.
  • “Clarifies the roles and responsibilities of primary assessors, secondary assessors, and division directors (who, under this MAPP, will no longer perform the role of a typical tertiary reviewer). This clarification will reduce duplicative and unnecessary work, which will increase FDA’s efficiency and effectiveness.”
  • “Establishes that OGD and OPQ will clearly communicate to applicants what deficiencies must be corrected for their ANDAs to be approved. This communication will enable applicants to develop high-quality re-submissions and to reduce the number of subsequent cycles to approval.”

The document goes on to describe the roles and responsibilities of the assessors in the review loop (very enlightening).  Remember that a MaPP is a document that describes how the Agency staff does its job and its publication is to provide greater transparency to industry.

This is what industry has been asking for, for years.  If FDA can deliver, then the review process should greatly benefit by taking the guess work out of what FDA may be asking for in their deficiencies.  Let’s hope this works to the advantage of both the FDA and industry; after all, teamwork by all players gets the ANDAs to the finish line!