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Major vs. Minor ANDA Amendments: Industry Takes Issue With FDA Draft Guidance

Posted 08 December 2017 | By Zachary Brennan 

Major vs. Minor ANDA Amendments: Industry Takes Issue With FDA Draft Guidance

The generic drug industry association, Teva Pharmaceuticals and Sanofi have raised questions in comments released this week on the US Food and Drug Administration’s (FDA) recent draft guidance on abbreviated new drug application (ANDA) amendments.

The draft explains when ANDA amendments will be designated as either standard or priority review, classified as either major or minor and receive a goal date based on certain factors, including whether a preapproval inspection is needed.

In terms of examples, FDA said in the draft that major amendments, if requested or taken in response to deficiencies, would include certain manufacturing changes or performing a new bioequivalence study, while minor amendments would include dealing with drug master file or label deficiencies.

In comments submitted to the docket earlier this week, the group known as the Association for Accessible Medicines (AAM) expressed "concerns about some of the examples that are proposed for classification as major. In addition, we have some concerns regarding the examples of the process FDA will employ to prioritize unsolicited amendments and in a few areas, we recommend clarification. We also recommend that the guidance specifically provide applicants the opportunity to explain why an amendment should not be categorized as a major."

The group also took issue with FDA’s intention to have the 2017 guidance replace earlier guidance from 2001, which it says was "the cornerstone of this decision" to classify amendments as "major" or "minor" and would "be a unilateral renegotiation of the agreed to [GDUFA II] Commitment Letter."

Teva, meanwhile, took issue with FDA’s classification of "all deficiencies associated with facilities as Major. Previously, the FDA would issue a CRL [complete response letter] on a facility and depending on the response from the sponsor, the FDA would then determine if it was a Major or Minor deficiency. We believe facility deficiencies should not automatically be classified as Major, as there are many issues that can be easily resolved and do not constitute a Major deficiency, such as if an alternate facility not used in the manufacture of the ANDA batches is removed due to compliance issues."

Teva also found it "very concerning" that for changes submitted after tentative approval, the draft "leaves the matter ambiguous implying that FDA may not review such amendments until the latter of timings…Teva respectfully requests the FDA to provide greater specificity in the Draft Guidance indicating that all such changes will not wind up being reviewed until the latest of possible time points, to avoid delays in market entry of a product on the earliest legally eligible date."

The Israel-based company also noted that the agency uses the phrase "data is inadequate and lacking" in some places in the draft, but does not clarify "what would be deemed inadequate (i.e., this is very subjective). We would appreciate it FDA could provide greater specificity by including examples in the Draft Guidance."

And Sanofi questioned FDA on if "the original ANDA is priority review, will subsequent amendments automatically be granted priority review or will the sponsor need to request?" The company also noted that the terms "priority review" is repeated in the guideline "but not defined. For better clarity, a reference to the MAPP ‘Prioritization of the Review of Original AND As, Amendments, and Supplements’ which defines the prioritization criteria should be included."


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