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# Wide Variance in FDA Subpart H Approvals: Attorneys
- URL: https://www.fdaweb.com/wide-variance-in-fda-subpart-h-approvals-attorneys/
- Published: 2016-08-09T12:00:00.000Z
- Updated: 2026-09-14T21:22:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136451

Attorneys **Frank Sasinowski** and **Alexander Varond** (Hyman, Phelps & McNamara) say that their analysis of the strength of scientific and clinical evidence for FDA’s 19 non-AIDS, non-cancer Subpart H approval determinations over the accelerated approval program’s 24 years shows that the agency “exercises extraordinary regulatory flexibility in its Subpart H approvals.” Writing in the *Food and Drug Law Journal*, the two [say](www,foodlawblog.net/FDA-flexibility-in-Subpart-H-approvals-Sosinowski-Varond%20%2800238267%29.pdf) that the agency exercises much more flexibility than is expressly provided for in the Federal Food, Drug, and Cosmetic Act, agency regulations, or its 2014 guidance on expedited programs for serious conditions.

The two researched the bases for FDA determinations when an unvalidated surrogate or intermediate clinical endpoint is “reasonably likely to predict clinical benefit.” For the 19 precedents, they say, they found wide variances between the quantum and quality of evidence on each of the three key factors outlined in FDA’s expedited programs guidance — **(1)** understanding of the disease; **(2)** understanding of the relationship between the drug effect and the disease process; and **(3)** clinical evidence for the unvalidated surrogate and the clinical benefit.

A company blog [post](http://www.fdalawblog.net/fda%5Flaw%5Fblog%5Fhyman%5Fphelps/2016/08/fdas-flexibility-in-subpart-h-approvals-assessing-quantum-of-effectiveness-evidence.html?ref=fdaweb.com) on the report says the “critical takeaway from the paper is that a robust showing on the key factors in FDA’s May 2014 guidance is not required, or, as the authors write, ‘you don’t need to knock it out of the park’ on all three factors.” The two attorneys say they hope to promote a better understanding of the circumstances under which Subpart H may be employed to facilitate the development and expedited review of new drugs with the potential to address unmet medical needs for serious and life-threatening illnesses and to mobilize expanded FDA use of Subpart H.