Having just returned from the DCAT meeting in New York City, all the buzz was about the seemingly imminent "Generic Drug User Fees." Everyone had questions, opinions, suggestions and speculated about the upcoming fees. The main questions were how big the fees would be (especially from smaller companies with limited resources), the impact the fees would have on ANDA approval times and when they would start. It seems everyone had a different answer or idea for the various questions. I heard people discuss feels as small as $20,000 per ANDA to upwards of $100,000 per ANDA. Timelines seemed to range from sometime during the second quarter of 2011 to sometime in 2012. Nobody had an answer to the impact that the fees would have on approval timelines but consensus seemed to be that a target of 18 month approvals would be ideal. The only thing that wasn't in question was whether or not the fees would happen. Everyone agreed that they would happen and most were optimistic to their success.
User fees have been implemented with varying success at the difference divisions at FDA. CDER has implemented PDUFA fees for NDA submissions with success in sticking to the review times in most instances. However, if you read the statistics regarding the decreasing number of new drugs being approved, the real question revolves around the cause of the timelines being kept is it due to the number of filings or due to the fees. Additionally, PDUFA fees for NDA are very large and have created a secondary issue. The FDA would love to remove all unapproved "Grandfathered" products from the market, however the large PDUFA fees make it cost prohibitive to submit an NDA for these products.
On the other side of the coin, CVM has issued reasonably sized filing fees for veterinary drug products but has placed the money in the general reserve fund (or at least so I have been told) and therefore approval times have not improved since implementing the fees. From what I hear, CVM makes OGD look good with the 30 month ANDA approval times.
One other question that poses itself is how do you address, the more than 2,000 ANDA that are currently backlogged once the fees start. Do they keep their place in line or do the get bumped for "priority" paid submissions.A definite concern on industry is if the fees are used to supplement or replace the current Federal Government's funding for OGD. If it replaces, I do not think things will get better quickly if ever. If it supplements the fees, then I think eventually we will get to a much better system wherein timely approvals are possible and to be expected.
In conclusion, it seems not matter what the FDA does, the problem will not be solved overnight. And if you read my previous blog; in Custopharm's opinion one of the primary reason for much of this backlog is poorly written applications that recirculate through the FDA over and over again.
We welcome any comments, thoughts, opinions and theories you may have on this subject matter. Please feel free to comment in the space below.
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.