FDA Encourages Resolving Disputes with Sponsors before Legal Actions
​[Posted on: Thursday, December 03, 2015] 

Scientific disputes are a common between sponsors and FDA reviewers. Most of the disputes occur because of interpretation of results of clinical and nonclinical studies and can be resolved with meeting the reviewers and addressing their concerns either by providing additional information or better explanation. But what should a sponsor do if there is continuing disagreement with the review team. According to FDA, escalate it to the next level of hierarchy within FDA, and keep escalating till a satisfactory resolution is obtained. This is FDA’s version of arbitration before taking legal action. FDA recently released a guidance detailing the types of issues that should be subject of the Formal Dispute Resolution Request (FDRR) and the processes to follow. Disputes commonly subject to FDRR are rejection of market approval application, rejection of breakthrough designation request, and clinical hold on an IND. Sponsors can also dispute rejection of a proprietary name or refuse to review an ANDA but those are much less common areas of escalation since the concerns raised by FDA are usually easy to address. The new guidance repeats a lot of best practices and rules that have existed for a long time at FDA but updates them to add biosimilars and GDUFA fees. As a general rule, one should try to address disputes with reviewers at the division level. Division Directors at FDA have significant power to amicably resolve disagreements between individual reviewers and sponsors. Although FDA accepts more than 81% of FDRRs, it sides with its reviewers in more than 90% of the cases, making one argue if the FDRR process is a good use of resources and time for the sponsor but the process does assure reduction of any individual personnel issues and provide a more robust, multi-user perspective on a given dispute, after all it would be hard to justify that all the various FDA staff are biased towards a given sponsor. It is also should work to convince the sponsor the futility of pursing a legal challenge to FDA’s decision as courts have a high rate of giving FDA the benefit to doubt when it comes to making decisions about approval of a given product.         

Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research