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FDA-Regulated Entities: Compliance and Enforcement Strategies

Speaker(s): Anne K. Walsh, Jennifer D. Newberger, Jennifer M. Thomas
Recorded on: Apr. 27, 2016
PLI Program #: 178025

Jennifer D. Newberger helps medical device clients develop regulatory strategies, prepare product applications, comply with labeling, advertising, and promotion, and address enforcement actions. Ms. Newberger also works on combination product issues, and has expertise in FDA's regulation of human tissue-based products. She provides counsel on FDA aspects of regulatory due diligence, contracts, and transactions, and represents medical device companies before FDA.

As part of her regulatory work, Ms. Newberger prepares IDE, 510(k), de novo, and PMA submissions or filings. In the area of compliance, she advises clients on MDRs, recalls, and QSRs. She has worked with companies ranging from start-ups to small and large manufacturers.

Before joining the firm, Ms. Newberger was a policy advisor at FDA's Center for Devices and Radiological Health. Her knowledge of the government's internal processes and priorities guides her interpretation of emerging medical device regulation. Earlier in her career, Ms. Newberger was an associate in the health care group of a national firm.

Related Experience

Medical Devices

• Helps clients develop regulatory strategies, including investigational device exemptions, 510(k) clearance, and PMA approvals.
• Handles appeals of premarket decisions, such as NSE letters.
• Advises companies on compliance with post-market regulations, including adverse event reporting, labeling and advertising, Part 806 (recall) reporting, QSR, and product modifications.
• Provides guidance on IDEs, clinical studies, and informed consent.
• Counsels clients on enforcement actions, including Form 483s, warning letters, product recalls, and injunctions.
• Advises companies on FDA regulation of software and mobile apps.
• Counsels medical device companies on compliance with labeling, advertising, and promotion regulations.
• Reviews contracts and security disclosure documents.
• Performs regulatory due diligence and post acquisition risk mitigation.

Product Jurisdiction

• Advises companies on product jurisdiction strategies.

HCT/P, Tissue Products

• Advises on whether products qualify for regulation solely as HCT/Ps under 21 CFR Part 1271.
• Provides counsel on GTPs, adverse reaction reporting and HCT/P deviation reporting.

Articles / Publications - see more articles

Commercialisation of Healthcare Global Guide, January 19, 2016
Thomson Reuters Book: Commercialisation of Health Care, November 4, 2013
Draft Guidance on Medical Device Recalls: Improvements Are Needed, July / August 2013
The US FDA and its Draft Guidance on Medical Device Appeals, April 2013
Summary of CMS Final Rule on Transparency Reporting, February 12, 2013

Speaking Engagements

FDA Workshop: Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids, April 21, 2016
ABA Family Law 2015 Spring CLE Conference, May 6-9, 2015 Fragile: Handle with Care! (Importing and Exporting of Gametes, The Hurdles and Ethical Implications" (Jennifer Newberger's topic to be determined))
FDLI Introduction to Medical Device Law & Regulations, April 3 - 4, 2013 Registration and Listing
FDLI: Introduction to Medical Device Law and Regulation, March 12 - 13, 2012 Clinical Investigations

Blog Posts - see more blog entries

Another Court Weighs In on Whether Off-Label Promotion is Per Se Illegal; Jury Finds Both Defendants Not Guilty on All Counts, February 26, 2016
Not All Devices are Created Equal: UDI Direct Marking, June 29, 2015
FDA to Weigh Risks and Benefits in Approving Investigational Device Exemptions, June 23, 2015
FDA Issues Draft Guidance Regarding Patient Preference Information for Medical Device Submissions, May 17, 2015
FDA Announces Progress Regarding Balancing Premarket and Postmarket Data Collection for PMAs, May 1, 2015


J.D., magna cum laude, University of Miami School of Law
M.P.H., International Health, Emory University
B.A., with honors, Anthropology, Washington University in St. Louis

Bar Admissions

District of Columbia

Jennifer M. Thomas works primarily on government investigations, civil and criminal litigation, and enforcement matters. As part of her practice, Ms. Thomas assists drug, medical device, food, dietary supplement, and cosmetic companies with managing responses to warning letters, subpoenas, civil investigative demands, and proposed consent decrees. She also advises clients on a range of FDA, FTC, and CPSC regulatory issues, including advertising and promotion, and represents clients before the National Advertising Division (NAD) and the Electronic Retailing Self-Regulation Program (ERSP).

Ms. Thomas has worked in private practice in the food and drug, and advertising fields since 2007, and joined Hyman, Phelps & McNamara P.C. in 2011. While in law school, Ms. Thomas participated in the Institute for Public Representation's First Amendment and Media Law Project, and interned for the Maryland Office of the Public Defender.

Representative Matters

• Successfully challenged FDA under the Administrative Procedure Act based on an arbitrary and capricious product classification decision.
• Defended a large medical device company in a civil False Claims Act case and parallel criminal investigation.
• Helped a medical device company respond to a HIPAA subpoena.
• Assisted a dietary supplement company with its response to a civil investigative demand requiring the production of advertising substantiation.

Awards & Recognition

• DC Super Lawyer, Rising Stars, 2015

Articles / Publications

FDA and Product Jurisdiction: Time for Reforms, February 1, 2016
Significant Settlements, Top 20 Food and Drug Cases, 2013 & Cases to Watch, 2014, January 2014

Blog Posts - see more blog entries

HRSA Loses the Battle, and Maybe the War, Over the Orphan Drug Rule, October 15, 2015
A Court’s Contempt for the Government in Bayer, October 5, 2015
Bayer Scores a Big Win in Action Involving Dietary Supplement Claim Substantiation, October 1, 2015
FINALLY! Multiple Generic Companies Receive FDA Final Approval to Market Generic Versions of Celebrex®, February 12, 2015
Basic Research and the "Reasonable Basis" Standard, December 29, 2014


J.D., cum laude, Georgetown University Law Center
B.A., summa cum laude, German and Political Science, St. Mary's College of Maryland

Bar Admissions

District of Columbia

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