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# When a Dispute Resolution Denial is a Win
- URL: https://www.fdaweb.com/when-a-dispute-resolution-denial-is-a-win/
- Published: 2018-10-10T12:00:00.000Z
- Updated: 2026-09-15T00:37:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142551

Attorneys **Josephine Torrente** and **Gugan Kaur** (Hyman, Phelps & McNamara) say that FDA statistics on the approval and denial rates of Formal Dispute Resolution Requests (FDRR) can be deceiving because a formal denial often can be coupled with agency guidance on a way forward that leads to the product being approved. [Writing](http://www.fdalawblog.net/2018/10/formal-dispute-resolution-a-different-perspective-on-wins-and-losses-2/?ref=fdaweb.com) in their firm’s *FDA Law Blog*, the two review three cases they were involved in that the agency counted as denials, while they and their clients considered them to be wins.

The post says the latest FDA statistics (published in 2016) indicate that in the period from 2003 to 2014, of the 140 unique appeals accepted and reviewed, CDER granted 23 (16%) and denied 119 (84%).

Torrente and Kaur say that in working with a client, they seek to develop a mutual understanding of what a “win” might look like, the likelihood of obtaining such a “win,” and how many rounds of review might be needed. “To the extent that achievable ‘wins’ are either too modest or too remote,” they say, “we would not advise submission of a FDRR. In our experience, then, the FDRRs that we pursue are the subset most likely to result in a palatable path forward, regardless of the ‘granted’ or ‘denied’ designation.”

The attorneys say that from 2015 through 2018 they assisted with at least nine products that completed the FDRR process. FDA would count them as 12 individual appeals and would likely list three (25%) as granted and nine (75%) as denied. But the outcome the lawyers and their clients saw was that two products were not offered an improved path forward (22% losses) and seven had an alternative, more favorable path forward to approval (78% wins).