Controlled Correspondence On the Rise Since GDUFA Implementation

The number of Controlled Correspondence (CC) sent to the Office of Generic Drugs (OGD) appears to be rising from year to year since the implementation of GDUFA (see chart below).  The numbers in this table were derived from the Activities Report of the Generic Drug Program for the respective Fiscal Years so far under the program.

The increase likely is due to both the final Guidance for Industry on Controlled Correspondence (here) and the MaPP 5200.3 Rev 1 (here).

The Final Guidance referenced above put limitations on what a Controlled Correspondence is and who may actually submit one that will have a GDUFA goal date of 60 days. The good news is that OGD is keeping up with its responses to Controlled Correspondences but the bad news is that the number appears to be spiking, as illustrated in the table below.

 

Fiscal Year # of Controls
2013 953
2014 1087
2015 1472
2016 1184*(1776**)

*Thru May 2016

** Projected for full FY 2016

Part of the increase may relate to many questions being answered informally by OGD staff prior to the OGD reorganization and implementation of the Guidance document.  It is understandable that FDA wants responses to questions documented for consistency purposes as well as for quality control of responses. However, industry has complained that some of the responses to the CCs do not actually answer the question that was asked or simply refer a requestor to a Guidance document where OGD believes the answer to their question lies.  If the requestor needs further information, it may generate another CC and may start the clock over again. This is frustrating for the industry and time- consuming for FDA.  Perhaps there can be a telephone conference option to resolve some of these issues.  As for advice to industry, be certain that your CCs are clear and that you specifically identify the question you need answered and, if there is something in a Guidance that is not clear, describe the issue in sufficient detail so that OGD can provide a more targeted response.

Please let us know what your experiences have been with the CC process and OGD communication in general over the last year.  Have things improved? We would be interested in your feedback.