It's well known that preparing a new or abbreviated new drug application (NDA/ANDA) for the US Food and Drug Administration (FDA) is a long, arduous and time-consuming affair. And according to new data just released by the agency, it would seem that popular wisdom is indeed correct.
On 24 March 2014, FDA put out a call for public comment on its drug application processes, which are used to support the approval of all new and generic chemical drugs, as well as some protein-based biologicals.
Under the Paperwork Reduction Act, FDA is charged with regularly reaching out to industry to determine if its information requests are proper and efficient and, if not, what can be done to improve those information requests.
For example, if NDAs were only accepted by FDA in paper form (they're not), industry might suggest that FDA accept them in electronic format in the future.
In addition, FDA is required to generate estimates of the time it takes for industry to comply with its requirements-filling out forms, tracking down data, submitting information and more.
A Lengthy Process
For NDAs and ANDAs, these requirements are found under 21 CFR 314, which detail everything from the checklists needed to allow FDA reviewers to know what's inside an application to the patent and methods of use information about the drug.
The requirements are extensive enough that even FDA's summary of the submission requirements takes up 2,500 words in its Federal Register notice.
But to really get a sense of how time-consuming NDAs are, it's perhaps best to look at FDA's estimated annual reporting burden, contained within its Federal Register notice.
In all, FDA estimates that it takes a total of 3.42 million hours of regulatory time just to submit NDAs each year. For reference, that equates to one person working every single hour for 391.5 years without a break.
Most of this time comes from just a few requirements. 21 CFR 314.50, or the actual filing of a NDA, is estimated to take 1,921 hours per sponsor, with 151 sponsors filing each year on average. 21 CFR 314.9 (a) and (d) detail submission requirements for generic drugs (ANDAs), and are estimated to take 480 hours on average based on 1,186 applications per year.
And despite application amendments for generic drugs taking just 80 hours to complete on average, the 10,675 FDA expects to receive each year means it takes a cumulative 854,000 hours of regulatory professionals' time each year. Similarly, ANDA supplements take 80 hours each to complete, and based on an estimated 5,611 submission each year result in 448,880 hours of regulators' time being taken up.
Comments on FDA's Federal Register notice should be submitted by 23 May 2014.
Federal Register Notice