The Lachman Blog

The 2 new MaPPs: 5200.4 Criteria and Procedures for Managing the Review of Original ANDAs, Amendments and Supplements 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 were released today by FDA. These two MaPPs describe how the Office of Generic Drugs (OGD) will prioritize review of ANDAs.

Although Office of Generic Drugs (OGD) total activity numbers (including issuance of Complete Response Letters (CRLs), etc.) will not be posted until about 2 weeks after the close of the month, it is disappointing that the number of approvals this late in the month appears only in the teens.
While there are many things going on at OGD (training of new staff, Guidance and Policy development, the reorganization to a Super Office, among other important things) the bottom line for industry is the number of approvals that OGD issues and the number and timeliness of OGD deficiency responses it receives. But approvals rule the roost in terms of industry importance because, after all, you cannot sell products that receive CRLs.

In previous post earlier this week, we were hoping to discover the Agency position on this particularly important issue. Thus, the Agency has decided to make a bright line of June 20, 2014 as the start date for the requirement for 3 batches with 6 months room temperature and 6 months of accelerated stability at time of original submission.

The Office of Generic Drugs’ (OGD) elevation to a Super Office in the Center of Drug Evaluation and Research has come at a challenging time for the Generic Drug Program. The new Office structure is presented below and represents a dramatic organizational change to us old timers. But this is progress and represents the need to move the program in a different direction for today’s environment.

If you are one of the about 600 ANDA applicants submitted in the first 19 days of June, or have one of the additional ~ 100-200 ANDAs that have not yet received notification of acceptance for ANDAs submitted prior to June 2014, a decision is expected soon on what stability requirements you will need to meet upon resubmission.

With 9 months gone in FY 2014 and the June Generic Drug Activity Report just released, things don’t look so good! The June ANDA submissions not only beat any previous one-month total ever, but shattered the previous record by almost 275%. The big problem when looking at the numbers in the Activity Report is not only seen in the number of ANDAs submitted, but also in the disturbing trend in the numbers in general.

The FDA announced today that the total collectable amount of fees under the GDUFA program (adjusted for inflation and salary increases) will be $312,224,000, up from the original $299 million that was authorized for year 1 of GDUFA. The good news/bad news is that ANDA and PAS fees decreased.

The FDA announced the availability of two Guidance documents – on Prior Approval Supplements and the other concerning Easily Correctable Deficiencies (ECDs). These eagerly anticipated documents have also published on the CDER web page.

The FR notice states relative to the Prior Approval Supplements (PAS) Guidance that “this draft guidance is intended to assist applicants preparing to submit to FDA PASs and amendments to PASs for abbreviated new drug applications (ANDAs). It describes FDA’s performance metric goals for PASs and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to the GDUFA performance metric goals.”