As the title illustrates this article will apply mainly to ANDA approval times since currently there are no PDUFA or User Fees for generic drug products. Even when and if the user fees reach generics there is no assurance that they will work the same way as they do for NDAs with action dates that are essentially adhered to.
During product development and submission preparation. everyone is familiar in at least some regard with the use of Gantt charts as a project management tool. Gantt charts are a great tool to track and plan in-house or contracted activities for which the sponsor has at least some direct control. Additionally, most Gantt charts I have seen go on to predict expected dates for FDA application acceptance, deficiencies and approval times. However these times were essentially based on empirical evidence or examples that is outdated due to ever changing conditions at the FDA.
We have divided the FDA review process into four main areas; FIFO cue time, review time, deficiency response time and approval time. Everyone's target is to get to the approval time as quickly as possible, however to get there it is essential to manage the three other phases as effectively as possible. Today I will address the FIFO Cue time.
The FDA operates most applications in a First In First Out procedure or FIFO. There are some exceptions such as expedited application or products on the drug shortage list. However, those are out of the scope of this discussion. Our definition of FIFO cue time is the time your submission sits around waiting for it to be picked up for review.
There are not many things that an individual can do to improve the FIFO cue time for a filing since, it is a general issue that effects all companies. The only things that you as an individual company can do to improve your cue time is to get your submission in the cue as quickly as possible. This means filing the submission earlier and ensuring that your company is using the Electronic Submission Gateway (ESG) to submit your filings.
Beyond these two things, the only ways to improve FIFO cue time is to have fewer submissions enter the FDA (which we all know isn't going to happen) or for the industry as a whole to submit higher quality filings that actually have a single cycle approval process. The key contributor for long FIFO cue times are applications that are essentially stuck in the system. By this I mean filings that have received multiple rounds of similar deficiencies and are not prepared in a manner that is easy to review. Typically these submissions are filed by companies that are not familiar with FDA processes or do not place emphasis on regulatory.
To improve this the industry needs to start looking at the regulatory function as an integral part of the product development process. Submitting an application to the FDA is much more than just following guidance documents and providing the data to the FDA. THe process is based on experience from previous applications, working with reviewers, and providing the information to the FDA in a logical easy to follow pattern. Keep in mind that each additional deficiency cycle add months to your product launch date.