At first glance it seems obvious, submit your ANDA(s) before June 20, 2014, when the FDA increases the stability requirement from one batch to three batches to save money. However, there are other things to consider. This scenario is similar to what happened in September 2012 right before GDUFA started.
In September 2012, everyone rushed to get their submission filed before the full ANDA fee (approximately $51,000 at that time) came into effect by submitting their application before October 1, 2012. This way a company only had to pay the backlog fee (approximately $17,000). This essentially saved companies about $35,000. However, in looking back what is the true cost of this action. Yes, the filing fee was less but in looking at the GDUFA legislation. It states 90% of the backlog applications will be acted on by the end of FY2017. Think about this for a moment, the FDA operates with a First In First Out approach. Which means those applications submitted in September 2012 are at the tail end of the backlog applications and should hear back sometime in 2017 or later. This is much longer than typical approval times and will cost years on the market. All in the name of saving $35,000.
Jumping to today, industry is repeating this same short sighted savings. Let's summarize what we know.
FDA will require 3 batches and six month stability.
GDUFA time lines come into effect for the first time October 1, 2014 which a target date of 15 months.
All submissions (excluding priority or Paragraph IV submissions) have no required time lines for review.
The FDA has heavily advertised how they have met or exceeded all GDUFA requirements.
There will be essentially zero ANDA filings between June 20, 2014 and October 1, 2015.
In looking at the aforementioned facts, we can easily see that there will be extra costs in the manufacture of the three batches and time lost in the acquisition of the extra three months of stability data. The extra costs translates comes from extra API cost, manufacturing costs and stability costs. However, in many cases there is some reduction in costs due to the use of bracketing and matrixing which can be employed with the three batch approach. That being said there is an extra cost which is substantial.
All applications currently filed have no review time frame associated with them, we have seen variability in receiving responses between 20-30 months from the time of filing. Obviously, there are many factors that cause this variation and many products are outside of this variation both longer and shorter. In any event, it much longer than the 15 months promised by the FDA starting October 1, 2014. Additionally, with essentially no submissions being submitted between June and October, the FDA will be able to get organized for the new submissions that will have target dates associated with them. Based on this, you lose three to four months waiting for the stability data but gain on average 9-12 months in review time. Doing simple math, the time savings are about half a year (6 months).
This obviously assumes that the FDA will achieve their time frames but based on the most recent FDA presentations they will do what they can and considering it is the first time target dates are in effect. I am sure at least initially they will. Other target dates, related to amendments will affect both submission types equally.
The final consideration is the status of your facility. If you have a facility that is filing a generic application for the first time, then there are establishment fee savings. The FDA has stated that facility fees are due whenever a facility for the first time has a referencing application active, submitted or pending on the due date. This means, if you submit in October 2, 2014 then your first establishment fee is due October 1, 2015. This with the shortened review time will result in the removal of one or two establishment fees prior to you approval. Currently the establishment fee is about $220,000 for domestic facilities and $235,000 for foreign facilities. This fee is an annual fee subject to change yearly. For facilities filing an ANDA for the first time the savings are significant.
In conclusion, there are several factors that define a companies path forward with respect to the timing of the filings. Many companies as pressing very hard to meet the June 19, 2014 filing time frame with the goal of saving money and time. Companies should evaluate the big picture to determine what is best long term as opposed to just looking at today. If you are pressing too hard complete a filing, the odds of having mistakes in that submission and therefore receiving a Refuse to Receive increase drastically. This has enormous consequences in lost fees, API costs, manufacturing costs, testing costs and most importantly time.
For assistance contact, Fred Defesche via email at firstname.lastname@example.org or via phone at 760-481-7811.
The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, and effective on October 1st, 2012, amends the Act by requiring additional information to be submitted for the registration of domestic or foreign drug facilities. This additional information includes the unique facility identifier of each drug establishment and a point of contact e-mail address. Furthermore, as of October 1, 2012, the re-registration period for domestic and foreign drug manufacturers has been changed to October 1st to December 31st of each year, instead of the previously more open-ended period of on or before December 31st of each year.
Custopharm can assist our customers with this service.
For assistance please call Dave McCleary @ 760 481-7590 or by email email@example.com
•859 ANDAs submitted in FY 2009
•263 PIV submissions
409 eCTD submissions
242 CTD submissions
30 paper CTD submissions
178 Gateway submissions
8 ANDA's RTR's (Refuse to Review) in FY 2009
•813 ANDAs submitted in FY 2010
•262 PIV submissions
119 CTD submissions
271 eCTD submissions
12 paper CTD submissions
411 Gateway submissions
13 ANDA's RTR'd in FY 2010
•853 ANDAs submitted (as of 9/26/2011)
•211 PIV submissions
60 CTD submissions
177 eCTD submissions
5 paper CTD submissions
611 Gateway submissions
•48 ANDAs RTR’d (as of 9/26/2011)
Relevance of numbers
100% of Original ANDAs being submitted are in CTD format (eCTD+paper CTD+Gateway)
Approximately 95% (or more) of original submissions are now electronic
Gateway submissions have continued to surge tremendously
58=(2008) 178=(2009) 411=(2010) 611=(2011)
RTR's as a percent of submissions is about 17% (data is incomplete as all of FY 2011 submissions have not been reviewed) FY 2008=15%, FY 2009=9%, FY 2010=14%
FDA currently has approximately 2500 ANDA's under review
FDA currently has approximately 4900 CMC Supplements under review
*All information above from GPhA Technical Conference held in Bethesda, MD - Oct 3-5 Kwadwo Awuah, Pharm D., R.Ph,. Regulatory Support Management Officer, Office of Generic Drugs, FDA
Industry average ANDA approval times are approximately 33 months, industry has done an excellent job converting to electronic ANDA filings from paper.
The focus for industry remains to provide the FDA 'well written' ANDA applications, this will assist the FDA with more efficient review times.
Custopharm filed the 1st eCTD ANDA in 2004, have filed over 100 since. Custopharm assists companies by through Regulatory assistance, when we fully write eCTD ESG ANDA's the average approval time is significantly faster than the industry average.
A new easy to use eCTD software is entering the final phases of beta testing and we are looking for volunteers to evaluate and provide input crucial to the finalization and completion of the software.
This software is based on the principles that software should be easy to pick up and use and therefore does not require extensive training and is designed to be "Mac" like in its ease of use. However, if anybody needs instructions we are more than happy to help.
Currently, we are looking for volunteers to evaluate the capabilities of the software and make recommendations as to how to improve it. Ideal beta testers would be regulatory consultants working on a variety of submissions types for the US market; however direct pharmaceutical employees are requested to register as well. This is a rare opportunity to use an eCTD software package at no cost.
We feel this is the first eCTD software to actually do what software is supposed to do and simplify the process for preparing eCTD submissions.
To be considered as a Beta tester please contact us directly by completing the form. Once we have made our selections we will advise you that you were chosen and provide instructions regarding the software installation.
There is a growing application backlog and median time for ANDA approval by FDA’s Office of Generic Drugs (“OGD”). The median ANDA approval time in Fiscal Year 2009 was 26.70 months. This is up from 21.65 months in Fiscal Year 2008 and up from 17.3 months in Fiscal Year 2003. Today, the ANDA backlog has surpassed the 2,000 application mark and is reportedly growing at about 100 applications per month. We understand that the median ANDA approval time is edging closer to
30 months from application submission.
Companies must submit ‘well written’ regulatory filings. There is so much effort in compressing development timelines, it is critical to file the most efficient ANDA/NDA/IND possible to compress review times.
If you are
not filing ‘well written’ regulatory filings it is costing your company time and money. We have countless examples of how the ‘well written’ Gateway filing improves approval timelines.
The above statistics are the building blocks to file a superior filing to the FDA, we continually implement what we learn to build a stronger A
NDA/NDA/IND. When Custopharm fully develops a product there are fewer review cycles with the FDA, each review cycle can cost months of ‘on the market’ time. Custopharm understands the technical aspect of development.
-Custopharm has filed many IND’s for development companies.
-Custopharm filed the first eCTD ANDA in 2004
has filed over 90 eCTD ANDA’s
as approved for the Electronic Submission Gateway in May 2008, filed over 475 since.
-Custopharm has filed 159 Gateway filings in 2009
-Filed 100+ Gateway filings through May 15th, 2010
-In 2009 Custopharm responded to over 100 deficiencies
Trust your Regulatory filings to Custopharm, a 'well written' ANDA has become more important
than an efficient development timeline. More time on the market means more profit in your bottom line.