An FDA Analysis of Formal Dispute Resolution in the Center for Drug Evaluation and Research: 2003 Through 2014.

Scientific and/or medical disputes will inevitably arise with regard to the US Food and Drug Administration's (FDA's) decision making related to drug development, new drug review, generic drug review, and postmarketing oversight. As these disputes can involve complex judgments and issues that are scientifically and commercially important, it is critical that FDA have procedures for effective and efficient resolution. FDA regulations allow a sponsor to obtain a review of an FDA decision by submitting a request for formal dispute resolution (an appeal). FDA's Center for Drug Evaluation and Research (CDER) received 137 appeal issues for fiscal years 2003 through 2014. However, sponsors can appeal the same issue multiple times, and each is considered a unique appeal; CDER received and analyzed 173 of these unique appeals. Of these 173 unique appeals, CDER accepted 140 (81%) for review and refused to accept for review 25 (14%). Eight (5%) were withdrawn by the sponsor prior to CDER making a decision whether to accept the appeal for review. Of the 140 unique appeals accepted and reviewed, CDER granted 23 (16%) appeals and denied 117 (84%). The analysis also examines an array of aspects of the process, such as (1) reasons why CDER rejected appeals, (2) reasons why sponsors submitted appeals, (3) the types of appeals that sponsors submitted, (4) the characteristics of the sponsors that submitted appeals (eg, size, past regulatory experience, legal representation), and (5) CDER's performance in meeting user fee goals associated with dispute resolution.