During the Hatch-Waxman meeting recently held at FDA headquarters, the new Commissioner alluded to two documents that he pledged would be issued hopefully by the end of this year. One was a Good ANDA Assessment MaPP and the other a Good ANDA review Practices document. In reviewing the history of the industry complaints regarding inconsistent reviews, these two documents could go a long way towards standardizing the process and further putting forth FDA expectations regarding both the filing (receipt) of an ANDA and the review content of an ANDA.
We have for too long seen OGD/OPQ ask for items out of the blue. Things that have not been asked of an applicant before, that we have in past blogs characterized as “nice to know”, but not necessarily essential to approval, as outlined in existing guidance or past FDA “expectations”. These kinds of questions drive the industry nuts, especially when they have had other ANDAs approved without those questions being asked. Current case-in-point are the requests for 21 CFR 820 (device) information being asked for transdermal delivery systems, MDIs and PDIs, foam or solution delivery devices like pumps and other parenteral products packaged in syringes. One firm told of a product recently approved where they submitted a supplement after approval and was barraged by a series of device questions that they were not asked during the original approval process. Maybe OGD/OPQ has changed its mind on what is needed in a drug-device combination product or how they plan to apply the drug/device definition to newly received ANDA and supplements, but it sure would have been nice to have a heads-up by FDA to the changing requirements prior to the questions being asked.
Changes such as these and “nice to know” questions certainly impact the ability of OGD to improve its first-cycle review efficiency and clearly catch industry totally off guard. Perhaps, when the (hopefully) detailed documents referenced above are issued, then industry may better understand and be prepared for FDA’s expectations. Hopefully, we will see those documents sooner rather than later and hopefully FDA will look at relevant industry comments submitted to past documents regarding the receipt, review, and approval process and incorporate those issues, comments, and suggestions into the documents. There needs to be a way to lock down requirements and avoid what industry still refers to as hitting a moving target.
There is still lots of work to be done on both the FDA’s and industry’s side to resolve and improve the ANDA submission and review process. Let’s hope this is a step in the right direction. It would be interesting to know what FDA thinks of this issue in terms of how to improve the situation.