Anne Walsh

Anne Walsh is an internationally recognized advisor to pharmaceutical, biotechnology, medical device, and other FDA-regulated companies, on high-stakes enforcement, compliance, and regulatory matters. She helps her clients develop strategies for responding to DOJ investigations or FDA enforcement actions, and then leads teams to execute on those plans. She has an impressive track record of clients she has successfully helped navigate or avoid government scrutiny.

Drawing on her three decades of experience both in private practice and government service, Anne thrives at helping companies respond to allegations of misconduct, managing regulatory crises, and resolving complex matters involving FDA-regulated products. She conducts internal investigations and develops compliance programs, and was selected to serve as a compliance expert under a Corporate Integrity Agreement imposed by the Department of Health and Human Services Office of Inspector General.

Complementing this work, Anne devotes considerable time to serving as a co-chair of the Women’s White Collar Defense Association DC Chapter, and as an Advisory Board Member of the International Bar Association’s Healthcare and Life Sciences Law Committee.

Prior to joining Hyman, Phelps & McNamara, Anne Walsh served as Associate Chief Counsel in the FDA’s Office of Chief Counsel, where she advised the agency on enforcement and compliance matters and worked closely with FDA field and headquarters personnel, the Department of Justice, and other federal agencies. She has nearly three decades of experience advising FDA-regulated companies on regulatory enforcement and compliance issues.

William & Mary Law School

J.D.

College of William & Mary

B.A.