Anne K. Walsh Director 202-737-4592
Anne K. Walsh

Overview

With more than 23 years of experience working with the pharmaceutical and medical device industries, Ms. Walsh brings FDA regulatory expertise to clients seeking to achieve their business objectives.  She regularly counsels clients facing FDA administrative actions like inspections, warning letters, and recalls.  But her passion is helping companies prevent or respond to government investigations, and she conducts internal investigations to achieve compliance and to best position her clients to defend against DOJ prosecutions.  Ms. Walsh has investigated and negotiated dozens of matters involving the FDC Act, the False Claims Act, the FTC Act, or exclusion authority of the HHS Office of Inspector General.

Corporate transactions serve as a natural complement to her compliance and enforcement practice, and Ms. Walsh leverages her FDA expertise on mergers and acquisitions, financings, and licensing deals involving life sciences companies.  She leads teams of attorneys within the Firm to conduct comprehensive regulatory diligence, and routinely taps into her broad network of international regulatory experts to address global concerns.  She advises clients on making determinations concerning the deal and its valuation, and to negotiate favorable terms for the agreement.

Prior to joining Hyman, Phelps & McNamara, Ms. Walsh served as Associate Chief Counsel with FDA’s Office of Chief Counsel, and received several awards for her work from FDA, DOJ, HHS Office of Inspector General, FDA’s Office of Criminal Investigations, and U.S. Attorney’s Offices throughout the country.

Ms. Walsh serves as the Firm’s Hiring Director and is a member of the Firm’s Diversity and Inclusion Committee.  After hours, she can be found on the Peloton leaderboard as arlington_annie, cheering on the sidelines of her daughters’ softball games or tennis matches, or playing with her menagerie of hermit crabs, goldfish, snails, and a cockapoo.

Education & Admissions

Education

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

Admissions

District of Columbia
New York

Experience

Successful Outcomes in Government Investigations

  • Settlement of a False Claims Act suit at an amount that was a 10-fold decrease from the government’s initial demand, on behalf of a contract manufacturer of medical devices marketing surgical instruments without FDA approval.
  • Dismissal of a civil qui tam matter against Orthofix, a medical device manufacturer, for marketing pain pumps outside the scope of its 510(k) clearance.
  • Declination of criminal prosecution for an OTC drug manufacturer related to allegations of off-label promotion of its product.
  • Declination to exercise exclusion authority by the HHS Office of Inspector General for a drug manufacturer based on a conviction related to off-label promotion.

Internal Investigations

  • Conducted a review of a global, publicly traded company’s response to allegations in the media involving the safety of the company’s medical devices, and prepared findings and recommendations for the corporate Board of Directors.
  • Led a multi-phased investigation in response to data falsification activities that occurred during an FDA inspection, including preparing responses to the FDA Form 483, conducting on-site interviews of current and former employees, and retaining and managing remediation activities by technical consultants.
  • Piloted an internal investigation at a mid-sized medical device manufacturer that was triggered by a disgruntled, former employee alleging nonconformances during the manufacturing process, prepared recommendations for improvements to the quality system and corporate culture, and advised on regulatory reporting obligations to FDA.

Corporate Transactions

  • Advised middle-market private equity firm on multiple acquisitions of contract research organizations, component manufacturers, and finished medical device manufacturers, and capitalized on strong international network of experts to conduct efficient foreign regulatory diligence
  • 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.
  • Provided advisory services to Owens & Minor on regulatory matters in acquisition of Halyard Health, Inc.’s Surgical & Infection Prevention business, at a purchase price of $710 million in cash.
  • Managed FDA diligence and prepared representations in credit agreements on behalf of lenders financing acquisitions involving life sciences companies.

Thought Leadership

  • Women’s White Collar Defense Association
    • Social Media Committee (2018 to present)
    • Washington DC Chapter Social Media Coordinator (2021 to present)
  • Food and Drug Law Institute
    • Compliance and Enforcement Conference, Planning Committee and Chair (2019) (2015 to 2020)
    • Annual Conference, Planning Committee (2021)
  • International Bar Association, North American Regional Forum Liaison Officer, Healthcare and Life Sciences Law Committee (2021-2022 term)

Honors & Awards

  • Who’s Who Legal: Life Sciences
    2021
  • DOJ Attorney General’s Award for Exceptional Service
    DOJ’s highest award for employee performance
    2010
  • Award of Appreciation
    FDA Office of Criminal Investigations
    2010
  • Award of Recognition
    U.S. Attorney’s Office, E.D.N.Y.
    2010
  • Cooperative Achievement Award
    HHS Office of Inspector General
    2010
  • Group Recognition Award
    FDA
    2010
  • Commissioner’s Special Citation
    FDA
    2009
  • Award of Recognition and Appreciation
    U.S. Attorney’s Office, N.D. Cal.
    2009
  • Outstanding Service Award
    FDA
    2008

Speaking Engagements

  • Panelist, FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law, Unwinding Temporary Measures from COVID-19, including Emergency Use Authorizations (EUAs), May 18-20, 2021
  • Panelist,  IBA Healthcare and Life Sciences Committee, Promoting and Selling Healthcare Products During COVID: International Guideposts and Ethical Considerations, April 29, 2021
  • Panelist, FDLI Enforcement, Litigation and Compliance Conference: For the Drug, Device, Food and Tobacco Industries, The Future of EUAs: What Happens Post-Crisis, December 15-16, 2020
  • Panelist, International Bar Association: IBA 2020 – Virtual Together Conference, Med-tech M&A, November 23, 2020
  • FDLI 2020 Annual Conference, Top Cases in Food and Drug Law, October 6-8, 2020
  • FDLI Enforcement, Litigation, and Compliance Conference, December 11-12, 2019
  • DIA Global Clinical Trials Disclosure & Data Transparency Conference, US Regulatory and Policy Updates: FDA and Clinicaltrials.gov Developments, September 19-20, 2019
  • RAPS, Ask Me Anything, Risk Management Principles: A Global Perspective, March 2019
  • Q1 Pharmacovigilance & Drug Safety Conference, Compliance: Post-Market Approaches to Drug Safety from Adverse Event Reporting to Mandated Studies, March 12-13, 2019
  • Moderator, Food and Drug Law Institute Enforcement, Litigation, and Compliance Conference for the Drug, Device, Food and Tobacco Industries, Top FDA Enforcement Cases in 2018, December 12, 2018
  • 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
Education

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

Admissions

District of Columbia
New York

Practice Areas
Industries
FDA Regulatory Categories