Old Way x New Way Crossroad

A New OGD/OPQ Review Assessment Coming to an Application Near You – But Not for a While!

Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research (CDER) at the AAM Annual Meeting today, gave some hope to generic applicants regarding the way agency assessments will be conducted in the not too distant future.  The goal is to improve the efficiency and effectiveness of the review process.  Why is this necessary?  Dr. Woodcock acknowledged that the current review paradigm is not sustainable with the increased number of submissions coming into the agency.

“We need to get to more first cycle approvals”, Woodcock said noting that while the rate of first cycle approvals has improved since GDUFA I from just under 1% prior to implementation of GDUFA to 10.7% in FY 2015, 14.3% in FY 2016, and 12.8% I FY 2017.  Without improvements in efficiency of the review process there is no hope of getting first cycle approvals to the almost 90% seen in the new drug’s review program.  Dr. Woodcock noted that it has taken 25 years since PDUFA I to get to that point in the new drug arena, but hopes the GDUFA efforts will get ANDA first cycle approvals moving in the right direction.

“We need to better understand the steady state of our review process to better know home many staff and resources we will need” to keep the input and output on an even keel.  She noted that there were 2666 ANDAs and amendments to ANDAs submitted to OGD In FY 2017, which were many more than anticipated.  The CDER Director acknowledged that FDA must be clear what is needed in an application and provide that information with definitive clearly to industry to assure greater certainty in the submissions process.

The new review paradigm is being referred to as KASA (Knowledge Aided Assessment and Structured Application) which should make the process more review checklist decision making, and limit the current long narratives that are crippling the current reviewer’s ability to meet the current workload.

How far along is FDA in reaching this objective?  Dr. Woodcock said “we are not there yet and it will probably take a few years to get there,” but this is the first acknowledgement from top CDER management that the review process as it currently exists is not sustainable. There is a current pilot project going on to address both drug product and drug substance in this new model. Review modules are being developed, refined, and will be implemented in the next few years. Once internal implementation is completed the modules will be rolled out and hopefully will help to reduce the number of refuse-to received actions and decrease the number of review cycles.

The same process improvements are also planned and are being used to some extent in facility assessments and the system appears to be working, as according to Dr. Woodcock, FDA has for the most part been meeting the goal of providing the results of the inspection in writing to facilities within 90 days after the close of the inspection.  She noted that this goal has been met at least since November 2017.   With more standardized inspection protocols this should also eliminate some of the subjectivity inherent in the inspection process

The changes being sought in the review assessment of ANDAs could benefit both the FDA and industry.  For FDA it may speed approval of products to market by reducing the burden of review and for industry it may provide greater review certainly and avoid having reviewers ask the nice to know rather than the need to know questions, a common complaint from industry ever since the implementation of Hatch-Waxman. How much documentation is needed for submission and how complex and extensive the FDA review must be will hopefully come into focus as this new review paradigm is instated.