Different FDA Divisions Follow Different Review Times: Who Knew!
[Posted on: Monday, August 27, 2015]

Sponsors have often complained that some divisions at FDA are inherently slower in responding than others. This trend permeates not only the review times for market approval applications but also to clinical trial applications and comment requests. In an article published in Nature Drug Discovery, senior officials at FDA acknowledged that different divisions do have different review times but defended it by saying that this is because FDA prioritizes high-impact indications such as cancer and infectious diseases, hence areas such as psychiatric drugs, dermatology and dental products lag behind. Also most FDA’s Fast Track Designations, Breakthrough Therapy designations, and Priority Reviews are in the areas of cancer and infectious diseases, hence the imbalance in review times. While on the face it may seem like a logical explanation, it is hardly the best one. FDA’s divisions involved in the so-called “non-priority” areas such as psychiatry, dental and dermatology are not necessarily involved in cancer or infectious diseases, so how can one understand those divisions systematically being slower? The main distinction seems to be the priority designations such as Fast Track or Breakthrough designations. Divisions that grant fewer priority designations are also slower. So, the best tip a sponsor can get out of this to try hard to get a Fast Track, Priority Review, Breakthrough, or Orphan designation for their product to benefit from a more efficient regulatory process.