Every so often, FDA revisits a policy set forth in FDA’s Manual of Policy and Procedures (“MAPP”) to reflect the Agency’s current practices. Though MAPPs really only govern the actions of the Agency, their content is important to understanding how FDA will approach certain requests. For example, FDA’s MAPP 5240.3, “Priority of Original ANDAs, Amendments, and Supplements,” sets forth the Office of Generic Drugs’ approach to Priority Review, which allows sponsors to understand when its ANDA or supplement may qualify for such Priority Review. Last week, FDA revised MAPP 5241.2 , Consolidation of ANDAs by the Office of Generic Drugs (“OGD”), which, along with insights into FDA’s considerations when a sponsor requests to consolidate ANDAs, provides an important reminder that sponsors should be aware of and considering consolidation ANDAs when possible.
MAPP 5241.2 explains that, historically, ANDA applicants would submit separate, original ANDAs for each strength of a generic drug for which the sponsor sought approval, resulting in multiple ANDA numbers for different strengths of the same drug product. For a variety of reasons, including streamlining the postmarketing or transfer of ownership requirements, a sponsor might want to consolidate its ANDAs for different strength of the same product into one “parent” ANDA. The parent ANDA is typically the ANDA for the strength used in bioequivalence testing and serves as the basis for bioequivalence waivers for the other strengths. In such an instance, the sponsor submits a consolidation request, including information on the formulations of all ANDAs applicable to the requests, all listed drugs referenced, and all bioequivalence studies and bioequivalence waivers received, as well as a copy of the consolidation request as correspondence to each ANDA identified in the request. Once a consolidation request is approved, the sponsor only needs to submit a Prior Approval Supplement or a Changes Being Effected supplement to implement the consolidation. MAPP 5241.2 does little to impact this process other than removing a requirement to identify all inactive ingredients in the product formulations.
While consolidation of ANDAs may not seem significant on its face, it is an important tool in managing user fee assessments. Under the Generic Drug User Fee Act, sponsors must pay annual program fees based on the number of separate ANDAs held as of the fee due date, October 1 of each fiscal year. A small business program fee is assessed for each entity, including its affiliates, that holds between 1 and 5 ANDAs; an entity that owns between 6 and 19 ANDAs is assessed a medium size operation generic drug applicant program fee; and an entity that owns 20 or more ANDAs is assessed a large size operation generic drug applicant program fee. The small business program fee is equal to one-tenth of the large size operation generic drug applicant fee while a medium size is equal to two-fifths of the large size. Consolidating ANDAs can help reduce the number of ANDAs that are considered in the calculation of the GDUFA program fee.
As FDA explains on its GDUFA website, ANDA consolidation requests approved by October 1 can affect the program fee tier assessed: a jump from the “medium size” program down to the “small size” – a reduction in ANDAs from 6 to 5 – could save a sponsor $500,000, and a jump from “large size” down to “medium” – 20 to 19 – can save a company over $900,000. But the catch is that the consolidation request must be approved by October 1. As FDA explains “if a company has 6 approved ANDAs and requests a consolidation of 2 ANDAs into 1, but the Office of Generic Drugs does not grant the consolidation request until after October 1, 2020, then the company’s tier would remain medium tier for FY 2021. (total remains 6 ANDAs).” That’s $500,000 that a sponsor need not pay if it were just to consolidate its ANDAs in a timely fashion. As such, MAPP 5241. 2 serves as a timely reminder as we approach the fall that companies considering consolidating ANDAs in an effort to address program fee assessments should get those requests in now!