Woodcock Addresses CDER Priorities for 2016 – What’s Hot for Generics?

 

Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research presented to the Centers’ priorities for 2016 (here).  There are a lot of crosscutting initiatives and priorities that impact all of the Center’s program areas, like ensuring good management, continuing to upgrade the IT platforms, working with stakeholders inside and outside the Agency, negotiating the new UFA’s (user fee acts), all with a lot of good work going on.  I thought I would concentrate on what Dr. Woodcock said about the generic program priorities and try to provide some color.

Her first order of business was to describe how the Center did against last year’s priorities. Again focusing on generic topics, Dr. Woodcock noted that FDA continues to meet and exceed all of its GDUFA I goals. The Office of Generic Drugs (OGD), now a Super Office, was stabilized (I think that means that FDA hired a lot of people into the right positions and organizational structure).  FDA stood-up the Office of Pharmaceutical Quality that support the quality review function of OGD.  The Center issued multiple generic drug guidance documents.

As far as priorities for 2016, on the top of the heap is the negotiations for GDUFA II which is ongoing and critical for long-term success of OGD, and also critical for increasing the number of approvals which will have a tendency to drive down pricing.  In regard to the issue of abuse-deterrent products, a priority is to issue the guidance on generic opioid products.  This is interesting as it was originally supposed to be issued by the end of 2015.

Continued staffing issues haunt CDER.  Dr. Woodcock indicated that there are over 600 vacancies in the Center but did not elaborate as to what programs are in most need.   She talked about reaching steady state in the generics program in about two years, which is consistent with what we have been predicting as the time point where input and output lines would cross, and (perhaps then) output might continue to exceed input to a point where most ANDA will be on track for GDUFA goals and better approval timelines.

Needless to say, while the generic program has made significant improvements, there are areas that present chokepoints in the process (like inspections).  It is nice to see that generic program issues are beginning to be fully recognized as just as important as new drug review issues at the FDA.