Hyman Phelps and McNamara
 
Anne K. Walsh
Director
Photo of Anne K. Walsh

(202) 737-4592
awalsh@hpm.com
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Practice Areas
Prescription Drugs and Biologics
Health Care
Medical Devices
Enforcement
Advertising and Promotion

Education
J.D., William & Mary Law School
B.A., Economics, College of William & Mary

Bar Admissions
District of Columbia
New York

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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 and medical device 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
• Advised Nichi-Iko Pharmaceutical Co., Ltd., the largest generic drug manufacturer in Japan by sales, in a $736 million deal to acquire Sagent Pharmaceuticals, Inc.
• 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.
• Negotiated on behalf of a software application developer a 90% reduction from the original demand made by the New York State Attorney General’s Office for alleged violations of New York consumer protection law based on health-related claims.

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
Women's White Collar Defense Association
Women in Bio
Food and Drug Law Institute
Committee Chair, American International Property Law Association, 2012 - 2013

Articles / Publications    -    see fewer articles
•  Court deals blow to mysteriously named whistleblower, blowing off precedent,  October 17, 2017

•  Congress Seeks a Statutory Fix to Stymied Off-Label Discussions,  May 2, 2017

•  DOJ Uses False Claims Act to Enforce FDA Manufacturing Rules,  April 7, 2017

•  Ninth Circuit Confounds Practice of Medicine and Off-Label Use Issues,  November 1, 2016

•  A Wolf in Sheep’s Clothing: When the Failure to Obtain a 510(k) for a Modification Is More Than a Regulatory Violation,  September 7, 2016

•  Top Food and Drug Cases 2015 and Cases to Watch 2016: United States v. Quality Egg, LLC,  2016

•  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

•  Knocking On Your Front Door: Government Visits To Employees' Homes,  August 19, 2011


Speaking Engagements    -    see more speaking engagements
•  Customer Centric Medical Information Conference, Interpreting New Guidance Based on Risk Tolerance, July 24-25, 2017
•  Customer Centric Medical Information Conference, Product Communication Consistent With Label & First Amendment Considerations, July 24-25, 2017
•  FDA-Regulated Entities: Compliance and Enforcement Strategies, FDA Deskbook: A Compliance and Enforcement Guide, April 28, 2016
•  American University Washington College of Law, Drug Promotion in the 21st Century: Off-label Marketing and First Amendment Concerns, March 31, 2016
•  ACI’s Promotional Review Compliance for Drugs and Devices, A Cheat Sheet on Specific Considerations for Promotion of Medical Devices or Combination Products, January 11-13, 2016


Blog Posts    -    see more blog entries
•  Court Deals Blow to Mysteriously Named Whistleblower, and Blows off Precedent,  September 27, 2017
•  Rehearing Urged for Bad Ninth Circuit Decision,  September 10, 2017
•  REMS Program Violations Result in Disgorgement and False Claims Act Liability,  September 6, 2017
•  Celgene Pays $280m in False Claims Act Case in Which U.S. Did Not Intervene,  August 1, 2017
•  Ninth Circuit Revives False Claims Act Case Applying Escobar Materiality Standard,  July 17, 2017