Author Archives: Erika Lietzan

Case To Watch: Eagle v. Azar’s Hidden Chevron-Step-1 Issue

by Erika Lietzan — Tuesday, May 14, 2019@lietzan

(Cross posted from Objective Intent) Recently I spoke at the annual meeting of the Food and Drug Law Institute (FDLI) on Eagle v. Azar, which is currently on appeal to the D.C. Circuit.  At first blush the case seems of limited importance, because Eagle Pharmaceuticals is simply challenging FDA’s interpretation of statutory language that has […]

FDA’s Reliance on User Fees

by Erika Lietzan — Monday, Sept. 4, 2017@lietzan

Cross-posted on Objective Intent. On August 18, the President signed the Food and Drug Administration Reauthorization Act of 2017 (FDARA), which reauthorized FDA to collect user fees in connection with new drugs, biologics, and medical devices for human use.  These user fee programs are colloquially known as PDUFA (innovator drugs and biologics), GDUFA (generic drugs), BsUFA […]

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Supporting FDA Product Reviews with User Fees Alone

by Erika Lietzan — Saturday, June 17, 2017@lietzan

Cross Posted on Objective Intent. Budget documents released by the White House and FDA in May suggest the Administration intends to restructure medical product user fees, so that a greater percentage of the agency’s work is fully user fee funded.  The Secretary’s May 15 letter, explaining the President’s earlier Budget Blueprint, suggests the goal is […]

FDA User Fee Churn

by Erika Lietzan — Sunday, June 11, 2017@lietzan

(Cross posted from Objective Intent) This post is one of several this summer that will focus on the pending FDA user fee reauthorization legislation.  It starts with a basic introduction: what is “user fee reauthorization,” and why must it pass? The short version:  this summer we are talking about FDA’s medical product user fee legislation, […]