FacultyFaculty/Author Profile

Anne K. Walsh

Hyman, Phelps & McNamara, P.C.

Washington, DC, USA

Practice Areas

Prescription Drugs and Biologics
Health Care
Medical Devices
Advertising and Promotion
J.D., William & Mary Law School
B.A., Economics, College of William & Mary

Bar Admissions
District of Columbia
New York

Anne K. Walsh
counsels clients on compliance and enforcement issues, including FDA inspections, seizure and injunction actions, warning letters, and recalls. She focuses on defending companies against allegations of fraud related to marketing and promotion, cGMP and QSR, health care, and clinical studies, with particular emphasis on cases involving joint criminal and civil investigations under the FDCA and the False Claims Act (FCA). She also has successfully sued the government for violating the Administrative Procedure Act (APA). She applies her enforcement expertise to aid companies in compliance efforts, via internal investigations or risk assessment audits.

Ms. Walsh also performs transactional work related to mergers and acquisitions involving pharmaceutical companies. She leads teams of attorneys in conducting a comprehensive FDA-related diligence, and advises clients on making determinations concerning the deal and its valuation.

Ms. Walsh joined the firm in 2011 after serving as Associate Chief Counsel with FDA's Office of Chief Counsel from 2004 to 2010. At FDA, she worked with federal prosecutors and law enforcement agencies on civil and criminal violations of the FDCA. She won numerous awards for her work from FDA, the DOJ, the HHS Office of Inspector General, FDA's Office of Criminal Investigations, and U.S. Attorney's Offices. Before joining FDA, Ms. Walsh represented pharmaceutical and medical device clients at a major international law firm in D.C.

Representative Matters

  • Sought and won dismissal of a civil qui tam matter alleging FCA violations against Orthofix, a medical device manufacturer. 
  • Prepared responses to FDA for Agfa, a medical device manufacturer, concerning inspections of its domestic and international sites, and obtained prompt closeouts of those inspections.
  • Conducted an internal investigation at a mid-sized OTC drug product manufacturer to minimize exposure against a potential whistleblower complaint.
  • Obtained a declination of federal criminal prosecution on behalf of an OTC drug manufacturer related to allegations of off-label promotion of its product. 
  • Prepared a warning letter response to FDA on behalf of a South Korean device manufacturer, using Korean language skills to translate for the company, its customers, and FDA. 
  • Successfully challenged FDA under the APA for acting arbitrarily and capriciously in a classification decision, on behalf of PREVOR, a medical device client. 
  • Negotiated with HHS Office of Inspector General on behalf of a drug manufacturer to avoid a Corporate Integrity Agreement or potential exclusion based on a conviction related to off-label promotion. 
  • Conducted due diligence on behalf of the acquiring company for an asset purchase involving 15 different drug products.

Awards & Recognition

DOJ Attorney General's Award for Exceptional Service - DOJ's highest award for employee performance, 2010
FDA Office of Criminal Investigations, Award of Appreciation, 2010
U.S. Attorney's Office, E.D.N.Y., Award of Recognition, 2010
HHS Office of Inspector General, Cooperative Achievement Award, 2010
FDA, Group Recognition Award, 2010
FDA, Commissioner's Special Citation, 2009
U.S. Attorney's Office, N.D. Cal., Award of Recognition and Appreciation, 2009
FDA, Outstanding Service Award, 2008
Executive Office for U.S. Attorneys, Director's Award for Superior Performance, 2006
Office of Inspector General, Cooperative Achievement Award, 2006
FDA, Award of Merit, 2005

Professional Affiliations

Food and Drug Law Institute
Committee Chair, American International Property Law Association, 2012 - 2013

Articles / Publications - see more articles

A Warning Letter on FDA's Expansive Interpretation of Its Facilities - Inspection Authority, March 13, 2015
Significant Settlements, Top 20 Food and Drug Cases, 2013 & Cases to Watch, 2014, January 2014
Examining Hot Button Areas for FDA & Related Government Enforcement, February 12, 2014
What Can You Say?: Uncovering Trends in Recent Medical Device Enforcement Actions, September 2, 2013
Garbage Runs, Fake Identities, and Surprise Home Visits - Strategies to Deal With FDA's Nontraditional Investigative Tools, June 20, 2012

Speaking Engagements - see more speaking engagements

ACI’s Promotional Review Compliance for Drugs and Devices, January 11-13, 2016 A Cheat Sheet on Specific Considerations for Promotion of Medical Devices or Combination Products
Promotional Review Compliance for Drugs and Devices, January 11-13, 2016 A Cheat Sheet on Specific Considerations for Promotion of Medical Devices or Combination Products
Forum on Fraud and Abuse in the Sales and Marketing of Medical Devices, March 12-13, 2015 AKW Chairperson and 3/11 Co-Presenter: Understanding and Adapting to New Guidance Regarding the Parameters of Conversation and Dissemination of Information Regarding Off-Label Use of Medical Devices."
Enforcement, Litigation and Compliance Conference, December 8-9, 2014 Anne Walsh is presenting at the Enforcement, Litigation and Compliance Conference
Personalized Medicine Bootcamp, Part III: Regulatory Oversight of Genetic Products and Services Webinar, April 23, 2014 Moderator

Blog Posts - see more blog entries

The Government Really Means It This Time (Part II), November 22, 2015
HP&M’s Anne Walsh to Speak at ACI’s Forum on Promotional Review Compliance for Drugs and Devices, November 19, 2015
Is This the New Beginning of Individual Prosecutions? Probably Not., November 11, 2015
Warner-Chilcott Resolution Includes Indictment of President, 11/11/2015
Warning Letter? What Warning Letter? . . . Latest Developments in Pacira and a Look at FDA’s History of Withdrawing Warning Letters, October 29, 2015

Anne K. Walsh is associated with the following items:
Treatise  Treatise FDA Deskbook: A Compliance and Enforcement Guide
Journal Chapter  Journal Chapter Free Speech and the Future of Off-Label Promotion Under a Trump Administration - The Current: The Journal of PLI Press, Vol. 1, No. 1 (Summer 2017), Monday, July 10, 2017
Treatise Chapters  Treatise Chapters FDA Civil Enforcement Actions - FDA Deskbook: A Compliance and Enforcement Guide, Wednesday, November 14, 2018
Internal Investigations; and Appendices 20A-20B - FDA Deskbook: A Compliance and Enforcement Guide, Wednesday, November 14, 2018

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