Draft Guidance Establishes Generic Application Performance Goals

An FDA draft guidance outlines how Generic Drug User Fee Act (GDUFA) performance metric goals would apply to amendments to Abbreviated New Drug Applications (ANDAs).

The FDA announced the draft guidance in the July 11, 2014, Federal Register. The comment deadline is September 9, 2014. The draft guidance, once finalized, will replace a December 2001 guidance covering major, minor, and telephone amendments to ANDAs. According to the FDA’s introduction to the draft guidance, the older regulations did not accommodate the agency’s new amendment review system and GDUFA performance goals.

Performance goals in the draft guidance apply to amendments submitted on or after October 1, 2014, unless the amendments pertain to an ANDA or a prior approval supplement that was submitted prior to that date.

In general, the review process is meant to encourage high-quality ANDA submissions and to eliminate the multiple review cycles that occur when the FDA must reassess applications because of amendments or incomplete data. Many review cycles can extend or eliminate the anticipated review schedules, the FDA says.

Goal approval dates are incremental, and time to approval is calculated based on the submission date. Amendments and their accompanying review do not shorten an application’s approval process, the FDA noted.

The draft guidance establishes goal approval periods based on amendment tiers and whether the amendment is required by the FDA or is an unsolicited submission by a manufacturer. Tiers are divided into subtiers to cover whether the changes fall into the FDA’s major or minor designations.

Under the draft guidance’s approval schedule, amendments in the highest tier would be approved 10, 3, or 6 months after submission, depending on whether the amendment is major or minor. The FDA anticipates 10 months for approval of the first FDA-required major amendment. It expects to approve the first through third FDA-required minor amendments 3 months after submission, and the fourth and fifth FDA-required minor amendment within 6 months of submission.

The FDA’s performance metrics for amendments within the first tier would have the agency reviewing and acting on 60% of first major amendments, first through third minor amendments, and fourth and fifth minor amendments within the established time periods in fiscal year (FY) 2015. In FY 2016, the agency expects to review and act on 75% of amendment submissions within its established time periods. It expects to act on 90% of amendment submissions within first-tier time periods during FY 2017.

Second-tier amendments include any unsolicited amendments that did not fit tier-1 requirements. Those should be approved 12 months after being submitted, the guidance states. The agency expects to act on 60% of tier-2 amendments in FY 2015, 75% of tier-2 amendments in FY 2016, and 90% of tier-2 amendments in FY 2017.

Tier-3 amendments, which include any required major amendments after the first, and any required minor amendments after the fifth, have no review and action goals. As a result, GDUFA establishes no performance goals for tier-3 amendments, the draft guidance states.

The FDA can change an amendment’s initial classification if the type, quantity, or data complexity does not fit its current status. The ability will allow the agency to allocate enough resources for amendment review.