By Jeffrey H. Brochin, J.D.
The FDA gave applicants preparing to submit abbreviated new drug applications (ANDAs) recommendations to avoid common, recurring deficiencies in a draft guidance for industry titled "Good ANDA Submission Practices." The deficiencies discussed may lead to a delay in the approval of an ANDA, and the FDA is trying to minimize the number of review cycles necessary for approval. In conjunction with the draft guidance, the FDA issued a Good ANDA Assessment Practices Manual of Policies and Procedures, which establishes good ANDA assessment practices to increase operational efficiency and effectiveness (Notice, 83 FR 532, January 4, 2018).
Background. The Generic Drug User Fee Amendments of 2012 (GDUFA I) (Title III of P.L. 114-144) was designed to increase the likelihood that American consumers would have timely access to low cost, safe, effective, and high-quality generic drugs, and to improve the predictability of the ANDA review process. Although it resulted in a significant and sustained increase in communications between the FDA and industry, approximately half of all ANDAs with GDUFA review goals required three or more review cycles to reach approval or tentative approval. For both the reauthorization of GDUFA (GDUFA II) (part of the FDA Reauthorization Act of 2017 (P.L. 115-52) (see Bipartisan bill reauthorizing FDA user fees heads to the President’s desk, August 4, 2017)) and the GDUFA II Commitment Letter (see FDA’s commitment letter, October guidance clarify GDUFA II changes, enhancements, November 6, 2017), the FDA worked with the generic drug industry to try to overcome these inefficiencies.
GDUFA II. GDUFA II includes important program enhancements to improve the predictability and transparency of ANDA assessmentsand to minimize the number of review cycles necessary for approval. These program enhancements are intended to foster the development of high-quality submissions, ensure the timely resolution of filing reconsideration requests, promote the correction of deficiencies in the current review cycle, and support the development of high-quality resubmissions.
Increasing competition, decreasing deficiencies. The draft guidance was developed as part of the FDA’s "Drug Competition Action Plan," which, in coordination with the GDUFA program and other FDA activities, is expected to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. Together, the draft guidance and the Manual of Policies and Procedures are intended to build upon the success of the GDUFA program and to help reduce the number of review cycles for an ANDA to attain approval.
The draft guidance describes common, recurring deficiencies identified during the FDA’s substantive assessment of an ANDA with respect to: (1) patents and exclusivities; (2) labeling; (3) product quality; and (4) bioequivalence (BE). It then provides recommendations to applicants on how to avoid such deficiencies.
Amendments to an unapproved ANDA. One area of the draft guidance in particular should prove most helpful to applicants in responding to an unapproved ANDA. The ANDA regulation provides that an amendment to an unapproved ANDA must contain either a verification that none of the following changes are contained in the amendment or "an appropriate patent certification or statement" or "a recertification for a previously submitted paragraph IV certification" if approval is sought for (1) a new indication or other condition of use; (2) a new strength; (3) an other-than-minor change in product formulation; or (4) a change to the physical form or crystalline structure of the active ingredient.
Notwithstanding the requirement, many applicants have failed to provide either an appropriate certification or statement (or recertification) or the required verification statement in their amendment to an unapproved ANDA. To address this requirement, the FDA guidance recommends that applicants provide an appropriate patent certification or statement (or recertification) or, if applicable, include a verification statement in the cover letter of their amendment to an unapproved ANDA.
Applicant’s responsibilities. The draft guidance does not include a comprehensive list of all of the deficiencies identified during ANDA assessment and the FDA points out that it is each applicant’s responsibility to submit a high quality, complete application that the agency can approve in the first review cycle. FDA strongly encourages applicants to review the FDA regulations and all applicable guidances for industryto understand the FDA’s current thinking on each topic.
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