At the Generic Pharmaceutical Association’s Fall Technical Conference on October 29, 2013, speakers from the Office of Generic Drugs (OGD) provided a glimpse into the review accomplishments for the first year since GDUFA was passed, and as to how OGD will change its process to assure timely OGD review.
Under GDUFA in FY 2013, the Agency collected $296 million of the $299 million authorized by Congress. So what did Industry get for the money? Some of the review accomplishments are as follows:
- OGD has hired and has begun the training process for over 100 people under the GDUFA program in FY 2013
- OGD has issued 1st Action Letters on about 30% of original applications and Prior Approval Supplements (PAS) from the backlog applications
- Complete response (CR) letters issued:
- ANDA CR with inspection results, over 470
- ANDA CR without inspection results, over 600
- PAS CR about 320
- Completeness and acceptability review for DMFs , over 1700 (with a resultant 1200 of those DMFs placed on the Available for Reference List)
- DMF CR letters, over 275 and about 500 DMF No Comment Letters
In addition, OGD officials indicated that there will be a number of Policy and Guidance documents forthcoming to address some of the major concerns that Industry has raised. Keith Flanagan, OGD’s Regulatory Counsel noted the following topics were being worked on for issuance by the Agency’s Policy Group :
- Prioritization Policy for ANDAs for drug shortages, PEPFAR applications, public health issues and paragraph III and IV applications, GDUFA year one and two applications, as well as how to address the prioritization of the backlog applications
- Guidance to address ANDA quality and the current multiple cycles of review
- Guidance on tier 1, 2 and 3 amendments
- Clarity on supplements
- Clarity on Controlled Correspondence
In addition, OGD noted that it has met all of the GDUFA first year goal commitments. There was a very high rate of self-identification by facilities, the Agency has published an arrears list and there are some signs of improved facility inspection coordination. In that regard, .inspections will be scheduled for facilities and bioequivalence testing sites within a few days of receipt of your applications, so be sure your facilities are ready for inspection when the application is submitted.
These indicators demonstrate that OGD and FDA are moving in the right direction, although there is still a lot of work to do.