The OGD awarded 580 approvals and 146 tentative approvals in 2015. This total includes 99 approvals and tentative approvals in December 2015, the most approvals and tentative approvals granted in a single month since the start of the generic drug programme. The OGD also issued 1,278 Complete Responses or written letters to applicants identifying deficiencies that applicants need to resolve before approval of an abbreviated new drug application (ANDA).

The increase in generics approvals has been attributed to the reorganization and increased review capacity at the OGD, which was made possible due to hiring of more staff. These staff increases were made possible by the introduction of the Generic Drug User Fee Amendments (GDUFA), which enabled FDA to collect user fees from generics manufacturers. The OGD hired approximately 125 new employees in 2015 to achieve GDUFA mandates to hire additional staff to support the growing generic drug programme.

The performance goals outlined in the GDUFA require FDA to review 60% of generics applications submitted in FY2015 as ANDAs within 15 months. FDA has set further goals for FY2016 and FY2017 to review 75% of ANDAs within 15 months and 90% of ANDAs within 10 months, respectively [1].

Another major commitment of GDUFA was to take a first action, by 2017, on 90% of the ‘backlog’, those applications pending prior to GDUFA as of 1 October 2012. By the end of 2015 the OGD had completed first actions on 84% of the 2,866 pending ANDAs and on 88% of the 1,873 pending prior approval supplements (PASs). This brings the OGD already close to the 90% goals set for 2017. The OGD also approved 90 ‘first generics’, thus adding a new cost-saving generic alternative for 90 brand-name drugs. FDA considers first generics to be a public health priority and prioritizes review of these submissions.

At the end of 2015, FDA had met or exceeded all currently measurable performance goals outlined in the GDUFA Commitment Letter. Despite this, FDA admits that it still has ‘a lot more work to do’ and will hold a public meeting on 20 May 2016 to solicit valuable feedback on its regulatory science initiatives.

Related articles
GDUFA regulatory priorities for 2016 include complex drugs

FDA making progress with ANDA backlog

Reference

1. GaBI Online - Generics and Biosimilars Initiative. FDA’s faster approval of generics to benefit Indian drug makers [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 6]. Available from: www.gabionline.net/Generics/General/FDA-s-faster-approval-of-generics-to-benefit-Indian-drugmakers

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