Anna Sims

Anna Sims provides strategic regulatory and policy advice on a wide range of complex matters for pharmaceutical and biotechnology clients. Using insight gained through her experience at the FDA, she focuses her practice on life-cycle management issues and related advocacy.

Prior to joining the firm, Anna was an Associate Chief Counsel in the FDA’s Office of Chief Counsel (OCC). She was Team Lead for OCC’s Hatch-Waxman Team and served as OCC’s Liaison to FDA’s Center for Drug Evaluation and Research’s (CDER) Exclusivity Board. She regularly advised FDA’s Office of Orphan Products Development (OOPD) on orphan-drug designation and exclusivity issues. She also regularly advised other offices within the agency, such as the Office of Generic Drugs (OGD) and Office of New Drugs (OND) on abbreviated new drugs applications (ANDAs) and 505(b)(2) applications, including approvability issues, 30-month stays, carve outs, exclusivity determinations, and citizen petitions. Her practice at the agency also included significant work on priority review vouchers and counseling on the Biologics Price Competition and Innovation Act, including issues related to reference product exclusivity and biosimilar licensure standards. She was lead counselor for FDA on a number of high-profile disputes, including the landmark orphan-drug case Catalyst Pharms., Inc. v. Becerra, 14 F.4th 1299 (11th Cir. 2021). She also has experience counseling on postmarket safety issues.

Prior to the FDA, Anna spent several years in private practice, advising on a wide range of FDA-regulatory issues. As part of her work, she conducted due diligence for corporate deals involving FDA-regulated products.