Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research (CDER) noted that her vision of the reorganization for the Center is to have “one voice for quality across all drug products including biotech.” She also indicated that while this has been a need of CDER for a while, she gave GDUFA credit as a major driver of this current effort.

FDA wants to make certain that regulations are actually “patient centric”, or in other words, what matters to patients-and that is basically quality and affordability.

FDA intends to focus more on risk stratification using a standards-based review – clear standards that FDA and Industry understand, which will (hopefully) reduce the amount of documentation necessary for application review and approval. The overall goal of the approval process is to make sure that quality drugs are available to the public.

In speaking about the development of the Office of Product Quality (OPQ), Dr. Woodcock intends to rely more on specialization of the review staff to bring applied knowledge for a more effective and efficient review.  For example, relative to APIs, we should look at where the risks are (failure modes); how can API failure result in clinical implications; how are or how can the risks be mitigated, and an assessment of whether the analytical methods are robust.  She wants to make sure FDA understands those risks, and to design a review process that addresses those risks.

The same type of understanding should be developed for drug product quality to show how the product can fail in market, by using clinical failure modes for drug products and developing clinically relevant specifications.

In OPQ, the staff will be divided up by specialty (Process, Formulation and Quality, Process and Facility Review, and Surveillance), so no one person has to do the soup-to-nuts review, they will have specialists that can concentrate on their area of expertise.

OPQ will look to risk-based approaches for quality issues (CMC), as well as facilities, based on previous Agency knowledge and behaviors of firms and also (relative to facilities) FDA should take into consideration foreign inspectional results and cultural issues that might relate to quality.

Some of the major changes that can be expected in the generics program include:

  • Most generics will be reviewed by dosage form by specialized groups.
  • OPQ will have one voice for microbiology review – all micro units are to be combined into one.
  • Centralized strong project management for the new organization, with new document management system
  • Centralized policy office with policy functions for CMC and quality issues and inspectional functions to improve consistency.

The reorganization is scheduled for next year, in CY 2015.

Acknowledging that OGD has a huge workload in just backlog alone, Dr. Woodcock announced that CDER has formed “SWAT teams” to deal with each type of application in the backlog, but FDA needs your patience until the Agency can get its arms wrapped around the backlog.  Teams out of the Office of Pharmaceutical Sciences (OPS) led by Dr. Lawrence Yu have been formed to review pre-GDUFA prior approval supplements; another team also out of OPS will be reviewing the some 2600 pre-GDUFA backlog of Changes Being Effective (CBE)supplements. Dr. Woodcock states that next year is critical in turning the corner on getting the backlog under control before the other metrics of GDUFA kick in during year 3 of the GDUFA program. With GDUFA’s hiring goal this  of 50% of the 931 staff and training those new hires is a very demanding resource commitment, but Dr. Woodcock is confident that all of the GDUFA goals will be met or exceeded.

So if you have been getting calls from the New Drugs side of the house relative to your ANDA supplements, the above certainly explains what is going on.

We all hope that FDA will be able to meet and exceed its GDUFA goals and also that the talk about risk-based assessment (both in application review and facility inspections) that we have been hearing about since the late 1990s becomes something real and tangible that Industry can rely upon.