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FDA Deskbook: A Compliance and Enforcement Guide

 
Author(s): Anne K. Walsh, James P. Ellison
Practice Area: Enforcement (Life sciences), Life sciences, Pharmaceuticals, Regulation and compliance (Life sciences)
Published: May 2016
Supplement Date: Jan 2021 i Other versions can be found in the Related Items tab.
ISBN: 9781402426476
PLI Item #: 173127

FDA Deskbook: A Compliance and Enforcement Guide provides a comprehensive description of the complexities of compliance under The Federal Food, Drug, and Cosmetic Act (FDC Act) and practical suggestions on how FDA-regulated entities can avoid being the subject of an enforcement action by the federal government. It explains the legal framework created by the FDC Act and subsequent statutes, regulations, guidance and policies governing the food and drug industry.

Written by attorneys at Hyman, Phelps & McNamara, P.C., the largest dedicated food and drug law firm in the U.S., FDA Deskbook incorporates more than a century of cumulative experience from positions at FDA, the U.S. Department of Justice, the Drug Enforcement Administration, U.S. Attorney’s Offices, and regulated industry. The result is an essential guidebook, which aims to assist industry stakeholders by providing a wide-ranging review of compliance and enforcement under the FDC Act and related laws.

The book first details the ins-and-outs of FDA’s administrative actions (such as warning letters, import alerts, and recalls) and civil and criminal enforcement authorities. Chapters that follow highlight specific issues affecting the cross-section of FDA regulation:

  • Drugs, including OTC, prescription, and compounded drugs, and controlled substances
  • Medical devices, including in vitro diagnostic devices
  • Food and dietary supplements
  • Tobacco
  • Animal products
  • Cosmetics
Importantly, FDA Deskbook contains chapters focused on hot button issues, such as advertising and promotion, fraud and abuse, and good manufacturing practices. The FDA Deskbook proposes best practice tips, including how to deal with FDA inspections, alternatives to conducting internal investigations, and potential defense strategies for use in enforcement proceedings. Its up-to-date coverage helps practitioners to achieve compliance and avoid enforcement action.
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Practice Areas

Health Care
Enforcement
Consumer Product Safety Commission
Education

J.D., Order of the Coif, University of Virginia School of Law
A.B., magna cum laude, Woodrow Wilson School of Public & International Affairs, Princeton University


Bar Admissions

District of Columbia
Maryland
Wisconsin
U.S. Court of Federal Claims



J.P. Ellison
represents clients in enforcement matters, particularly civil, administrative, and criminal cases. He also advises clients on government investigations and compliance matters. Mr. Ellison regularly represents clients in state and federal courts throughout the country. His clients include a wide range of companies and individuals regulated by FDA, FTC, DEA, and the CPSC.

Mr. Ellison's trial experience encompasses litigation on behalf of both the government and industry. He has a keen sense of the government's priorities in FDA, FTC, DEA, CPSC, and state attorney general enforcement matters. This insight enables Mr. Ellison to take a practical approach in advising clients of their options and how to achieve the best result.

Before joining the firm in 2007, Mr. Ellison was a trial attorney with the U.S. Department of Justice's Office of Consumer Litigation (now called the Consumer Protection Branch). In this capacity, he handled litigation matters involving FDA, FTC, and the CPSC. In addition to working as a federal prosecutor, Mr. Ellison was the Chief Compliance Officer and Regulatory Counsel for a D.C. government agency. Mr. Ellison served as a law clerk for the Honorable Diana Gribbon Motz of the U.S. Court of Appeals for the Fourth Circuit.


Related Experience

• Lead counsel for several drug manufacturers in connection with Medicaid drug pricing lawsuits brought by various state attorneys general.
• Lead counsel for several drug manufacturers in Federal False Claims Act suit.
• Prosecuted and defended Lanham Act cases as lead counsel.
• Lead counsel in law suits under the Administrative Procedures Act against federal government agencies, including FDA and DEA.
• Helps clients resolve matters on favorable terms short of litigation through consent decrees, civil settlements, and other negotiated resolutions.
• Advises clients on responses to pre-litigation enforcement actions by the government such as FDA warning letters, state attorney general informal inquiries, civil investigation demands, and administrative and grand jury subpoenas.

Articles / Publications

A Warning Letter on FDA's Expansive Interpretation of Its Facilities - Inspection Authority, March 13, 2015
The Curious Case of the Prosecution of Lawyer Paul Kellogg, March/April 2009
Hyman, Phelps & McNamara Issues Analysis Discussing the Implications of the Supreme Court's Wyeth v. Levine Decision, March 16, 2009

Speaking Engagements

ACI: National Forum on Pharmaceutical Pricing Litigation, October 2 - 3, 2012 Bolstering Trial Strategy in Litigation over AMP Calculations to Mitigate Exposure
FDLI Conference on Enforcement and Litigation, October 13 - 14, 2009 Enforcement in a Post-Wyeth, New Administration World

Blog Posts - see more blog entries

Paralyzed Veterans Is No More. Is Auer Next?, March 19, 2015
Former Officials of Peanut Corp of America Found Guilty; FDA Proposes to Require Supplier Verification Under the FSMA Preventive Controls Rule, September 22, 2014
Consumer Groups File Motion to Intervene in Vermont GE Labeling Litigation, July 24, 2014
DOJ Announces Significant Policy Shift on Electronic Recordings of Statements; Will Other Agencies Follow?, May 29, 2014
HP&M Comments on IND Guidance; Says FDA Lacks Authority to Impose Requirements on Non-drug Studies, April 8, 2014


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


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