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FDA Deskbook: A Compliance and Enforcement Guide

 
Author(s): James P. Ellison, Anne K. Walsh
Practice Area: Corporate & Securities, Health Care
Date: May 2016
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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J.P. Ellison represents clients in investigations, enforcement matters, and litigation.  He also advises clients on compliance matters. J.P. represents clients before state and federal agencies, Congress, and in state and federal courts throughout the country.  J.P.’s clients include companies and individuals regulated by FDA, FTC, DEA, CPSC, and state agencies.  He has experience with Congressional investigators, federal prosecutors and state attorneys general.

Before joining the firm in 2007, J.P. was a Trial Attorney at the U.S. Department of Justice, and the Chief Compliance Officer and Regulatory Counsel for a D.C. government agency.  He served as a law clerk for the Honorable Diana Gribbon Motz of the U.S. Court of Appeals for the Fourth Circuit.


With more than 21 years of experience in private practice and government, Ms. Walsh helps pharmaceutical and medical device companies comply with, and defend against, FDA regulation.  She regularly counsels clients on managing FDA inspections, and responding to seizure and injunction actions, warning letters, and recalls.  She has specific expertise in matters involving health care fraud, off-label promotion, and manufacturing practices, and has investigated and negotiated dozens of matters that have implicated False Claims Act liability and exclusion by the HHS Office of Inspector General.

Ms. Walsh frequently applies this compliance and enforcement expertise to aid clients needing FDA perspective in M&A transactions.  She leads teams of attorneys to conduct a comprehensive FDA-related diligence, and advise clients on making determinations concerning the deal and its valuation.

Her litigation experience is comprehensive and diverse, from defending product liability claims in state court, bringing suit under the Lanham Act, prosecuting individuals and corporations in federal court, and suing FDA for violating the Administrative Procedure Act.

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.