Lachman CONSULTANTS - Bob Pollock先生 2014-08-04
校译：识林-椒 2014-08-04
Garth Boehm 博士点评
我从来没有见过专利到期之前12-30个月的“窗口期”作为“捆绑式”审评的时间区间的。这是很重要的信息，尽管我认为是不明智的。
I have never seen this "window" of 12 to 30 months before patent expiration as the time zone for "bundling" approvals. This is important information, albeit ill advised in my opinion.
英文原文
2 New MaPPs (to Somewhere) that Provide Direction on ANDA Supplements and Amendments
Written by Bob Pollock • August 04, 2014
The 2 new MaPPs: 5200.4 Criteria and Procedures for Managing the Review of Original ANDAs, Amendments and Supplements (here) and 5240.3 (a revision of the old 2006 MaPP entitled Review Order of Original ANDAs, Amendments and Supplements) Prioritization of the Review of Original ANDAs, Amendments and Supplements (here) were released today by FDA. These two MaPPs describe how the Office of Generic Drugs (OGD) will prioritize review of ANDAs. In previous blog posts, we have discussed a concern about what will happen to cohort year 1 and 2 GDUFA ANDAs since there are no metrics associated with them. It appears from this MaPP that we now know – except for applications or supplements that receive expedited review based on the priorities outlined in these two documents, the cohort year 1 and 2 applications will be reviewed on a first-in first-reviewed basis as review resources permit. While this may not make industry very happy, those firms having applications or supplements that qualify for expedited review or have a GDUFA goal date may rest a little easier.
MaPP 5200.4 “describes the criteria and procedures by which the Office of Generic Drugs (OGD), Division of Project Management leadership will manage the review of generic drug submissions.”
“MAPP 5240.3 Rev.1 identifies categories of submissions that are public health priorities, including submissions containing patent certifications pursuant to 21 CFR 314.94(a)(12) (some of which are “potential first generic products”); submissions related to drug shortages; and submissions that are subject to special review programs such as the President’s Emergency Plan for AIDS Relief.
Industry, consumers and other stakeholders have a strong interest in the predictable and timely review of public health priority submissions. Expediting the review of such submissions is a key aim of the Generic Drug User Fee Amendments of 2012 (GDUFA).”
The implementation of MaPP 5240.3 now will dictate the review priorities of all applications, amendments and supplements at OGD. The categories for prioritizations include:
1) Submissions containing patent certifications pursuant to 21 CFR 314.94(a)(12)
2) Submissions related to drug shortages
3) Submissions that are subject to special review programs such as the President’s Emergency Plan for AIDS Relief
4) Submissions related to public health emergencies
5) Submissions related to certain government purchasing programs
6) Submissions subject to statutory mandates or other legal requirements
7) Supplements for which expedited review is requested under 21 CFR 314.70(b)(4)
The MaPP defines a rather complex set of conditions relative to expediting and prioritizing applications or supplements that are subject to certain patent and exclusivity protection. Much is the same on this specific topic but there are a few changes. For instance, timing of review to meet the 30 (or 40 months) tentative approval or final approval requirements such as not to cause forfeiture of 180-day exclusivity is specifically discussed in the MaPP. Also “[W]here a submission’s approval is dependent on the expiration of a patent (i.e. the submission contains a Paragraph III certification), or is dependent on the expiration of an exclusivity period, OGD and OPS/OPQ will seek to complete review of the submission in a manner that would permit approval prior to the last applicable patent expiration date or exclusivity date. However, with regard to ANDAs submitted on or after October 1, 2014:
ANDAs submitted within one year of the last applicable patent expiration date or exclusivity date will not be considered for expedited review, and no assurances can be provided that review will be completed in a manner that would permit approval by the last applicable patent expiration date or exclusivity date. This provision may be subject to exception in certain cases where it is determined that the submission must be expedited to address a public health concern. These determinations will be made by the OGD Division of Project Management and OGD management in consultation with other Agency personnel as necessary.
ANDAs submitted more than 30 months in advance of the last applicable patent expiration date or exclusivity date will not be considered for expedited review.”
Read these documents over carefully and be prepared to identify any application your believe qualifies for priority review and make certain OGD knows about the application. We will keep our ears open to see how these two documents are received by the industry. Our guess is that there will be some smiles and some tears!
