William H. Kitchens

Senior Counsel

Fax: 404.873.8645

Biography

Bill is a retired partner and senior counsel in the Food and Drug practice. He served as the firm’s managing partner from 1996–2008 and has also served as chairman of the Healthcare and Life Sciences practice.

Bill’s practice focuses on food and drug law and government investigations. He advises companies in the food, medical device, pharmaceutical and biotech industries on a wide range of issues, including strategies for obtaining Food and Drug Administration (FDA) approvals of new products, clinical trials, risk management, advertising and labeling, good manufacturing practices and post-approval safety requirements. He also counsels companies about recalls, market withdrawals, crisis management, responding to FDA inspectional observations and warning letters, the defense of anticipated enforcement actions and the negotiation of consent decrees. He has extensive experience defending clients in both administrative hearings and enforcement actions in federal and state courts involving the FDA, Federal Trade Commission (FTC), Drug Enforcement Agency (DEA), Environmental Protection Agency (EPA) and the U.S. Department of Agriculture. He also performs regulatory due diligence for clients in connection with financings, public offerings, mergers and acquisitions, and assists with Securities and Exchange Commission (SEC) regulatory filings and press releases to the investment community.

Bill has published numerous books and articles on food and drug law and regulatory law topics. He is an adjunct professor at Emory University School of Law, where he has taught a course in food and drug law since 1979. He lectures frequently on food and drug law topics, compliance, and trade regulation topics and is routinely invited to speak at industry, government and academic meetings.

Experience

  • Advised a biomedical company regarding labeling and advertising activities for multiple product lines.

  • Advised a leading manufacturer of frozen baked foods regarding labeling and advertising activities, and in advertising substantiation by the FTC.

  • Advised a leading supplier to the food service industry and manufacturer of non-dairy frozen foods concerning product recalls and market withdrawals to minimize business disruption, cost and damage to brand.

  • Advised a major food service distributor regarding USDA food safety investigations at multiple facilities.

  • Advised a pharmaceutical company regarding labeling and advertising activities for drug products.

  • Advised a research pharmaceutical company regarding compliance issues and related responses to the FDA.

  • Advised a urological physician regarding compliance issues and related responses to the FDA.

  • Advised an eye care manufacturer regarding labeling and advertising activities for device products.

  • Advised both sponsors and principal investigators of human clinical trials regarding compliance issues and related responses to the FDA.

  • Advised hedge fund clients concerning FDA regulatory actions affecting their investment in pharmaceutical company.

  • Advised multinational manufacturer of human biological and device products regarding approval strategies, advertising and promotional activities, and compliance issues.

  • Advised numerous medical device manufacturers concerning product recalls and market withdrawals to minimize business disruption, cost and damage to brand.

  • Advised start-up company in the area of hair restoration research regarding most advantageous regulatory pathway for development and marketing of biological-device combination product.

  • Assisted a Georgia-based biologics and device company with preparation of FDA submissions, including 510(k) premarket notifications, new drug applications (NDAs), medical device premarket applications (PMAs), biological license applications (BLAs) and adverse events reports.

  • Assisted a Georgia-based medical devices manufacturer with preparation of FDA submissions, including 510(k) premarket notifications and medical device premarket applications (PMAs).

  • Assisted a Georgia-based pharmaceutical company with preparation of FDA submissions and adverse events reports.

  • Assisted a Georgia-based long-term care facility with preparation of DEA submissions for pharmacy operation.

  • Assisted a New Jersey-based pharmaceutical company with preparation of FDA submissions, including 510(k) premarket notifications, new drug applications (NDAs), medical device premarket applications (PMAs), biological license applications (BLAs) and adverse events reports.

  • Coordinated regulatory due diligence for New-York based private equity firm evaluating acquisition of major medical devices company.

  • Defended a California-based non-dairy food manufacturer in FTC investigation concerning substantiation support for advertising claim promoting cardiovascular health and wellness.

  • Served as lead counsel for a biomedical company in connection with responses to FDA inspectional observations, warning letters, and FDA investigations, and the defense of seizure, injunctions and criminal actions in federal court.

  • Served as lead counsel for a medical device manufacturer in connection with responses to FDA inspectional observations and warning letters

  • Served as lead counsel for a nonprofit healthcare system in connection with responses to FDA inspectional observations concerning clinical trials.

  • Served as lead counsel for a pharmaceutical company in connection with responses to FDA inspectional observations, warning letters, and FDA investigations, and the defense of seizure, injunctions and criminal actions in federal court.

  • Served as lead counsel for a provider of frozen specialty seafood in connection with responses to FDA inspectional observations, warning letters, and FDA investigations, and the defense of seizure, injunctions and criminal action in federal court.

  • Served as lead counsel for an eye care manufacturer in connection with responses to FDA inspectional observations.

  • Served as lead counsel for an officer of a drug distribution firm in connection with DEA investigation and the defense of criminal action in federal court.

  • Serving as general counsel to the National Frozen & Refrigerated Foods Association.

Credentials

  • University of Georgia School of Law, Juris Doctor — 1973
  • Emory University, Bachelor of Arts — 1970,

    With High Honors

  • State of Georgia 1973
  • United States Court of Appeals for the First Circuit 1981
  • United States Court of Appeals for the Eleventh Circuit 1981
  • United States Supreme Court 1977
  • United States Court of Appeals for the Fifth Circuit 1974
  • United States District Court for the Northern District of Georgia 1974
  • Supreme Court of Georgia 1974
  • Georgia Court of Appeals 1974
      • American Bar Association—Section of Antitrust Law, Section  of Criminal Justice, Section of Litigation, Section  of Science and Technology, Section of Administrative Law (Food and Drug Subcommittee)
      • Atlanta Bar Association
      • Atlanta Bioscience Leadership Council
      • Food and Drug Law Institute
      • Georgia BIO Board of Directors
      • Metro Atlanta Chamber of Commerce Board of Directors, 2005–08
      • National Health Museum, Board of Trustees
      • Atlanta Bar Foundation, Fellow
      • Lawyers Foundation of Georgia, Fellow
      • State Bar of Georgia Access to Justice Resource Development Committee
      • Atlanta Legal Aid Society Annual Fundraising Campaign, Chair, 2008 and 2009
      • Food and Drug Law Journal, Editorial Board, 1981–87, 1996–2001
      • Georgia Law School Association Council
      • Southern Regional Task Force, Medical Technology Leadership Forum
      • Lawyers Club of Atlanta
      • Magistrate Judge Merit Selection Panel, The United States District Court (N.D.Ga.), 2010–present
    • The Georgia Law Review, Notes Editor, 1972–73

Recognition

    • Daily Report Lifetime Achievement Award, 2017
    • BTI Client Service All-Star, 2016
    • Best Lawyers in America (Biotechnology Law and FDA Law), 2007–present
    • Atlanta Lawyer of the Year, Best Lawyers in America (Biotechnology Law and FDA Law), 2014
    • Georgia Super Lawyers, 2013
  • Georgia Bio Community Award, 2006

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