Frederick H. Branding*

Phone: (202) 789-1212
Fax: (202) 234-3550

Fred Branding is a Principal Attorney with OFW Law. He is a registered pharmacist with extensive experience in pharmaceutical, food, drug, medical device, and cosmetic regulatory compliance and enforcement issues. His experience includes counseling and assisting medical products manufacturers in responding to government inspections, Warning Letters, investigations, and litigation. He has represented individuals and corporations in various government enforcement actions, including seizures, injunctions and prosecutions, as well as private litigation between businesses.

Fred has successfully defended a mass seizure of a major device manufacturer's products worth tens of millions of dollars. He works closely with clients in resolving regulatory issues involving agencies such as FDA, DEA, and USDA. He has assisted clients in negotiations with FDA to vacate decrees of permanent injunction in place for a number of years. He also has been successful in establishing new case law potentially advantageous to claimants in FDA seizure actions.

Prior to joining OFW Law, Fred served in private practice with firms in Chicago. He also served as Chief of the Civil Division of the United States Attorney’s Office for the Northern District of Illinois and Chief of the Psychotropic Drugs Unit of the United Nations International Narcotics Control Board in Vienna, Austria. While at the U.S. Department of Justice, he twice received the Food Drug Administration Commissioner’s Special Citation for outstanding contributions in the field of food and drug law enforcement. He is the author of several publications and has been a speaker and presenter at numerous meetings and conferences. For 20 years, he was Adjunct Professor of Law at John Marshall and Northwestern Law Schools. He received his pharmacy and biology degrees from Drake University and his JD from Illinois Institute of Technology Chicago-Kent College of Law.

*Practice within the District of Columbia is limited to matters and proceedings before federal courts and agencies.

Bar and Court Admissions

  • Illinois
  • U.S. Supreme Court
  • U.S. Court of Appeals - Seventh Circuit
  • U.S. District Court - Northern District of Illinois
  • U.S. District Court - Northern District of Illinois Trial Bar

Education

  • Illinois Institute of Technology, Chicago-Kent College of Law, J.D.
  • Drake University, B.S., 1968
  • Drake University, B.S., 1966

Professional Associations

  • Member, Food and Drug Law Institute
  • Member, Regulatory Affairs Professionals Society

Publications

  • "Understanding and Working with the Food and Drug Administration," Chapter in Legal Handbook for Doing Business in the United States, Compiled by Consul General of Switzerland, Chicago.
  • "Underdeveloped: FDA's Authority to Take Photographs During an FDA Establishment Inspection Under Section 704," Food and Drug Law Institute, Food and Drug Law Journal, Washington D.C.
  • "Preparing for and Surviving FDA Investigations," Food and Drug Law Institute Update.

Speeches / Presentations

  • "Introduction to Drug Law and Regulation," Regulation of Manufacturing/Inspections Workshop, Food and Drug Law Institute, Washington, DC, November 5-6, 2009
  • "Behind the Counter Drugs – A Middle Class in the United States, 2008 Symposium," National Association of Boards of Pharmacy, Tucson, AZ, December 4-5, 2008
  • "Introduction to Drug Law and Regulation: Import and Export Requirements and International Issues," Regulation of Manufacturing/Inspections Workshop Imports/Exports, Food and Drug Law Institute, Washington, DC, November 20-21, 2008
  • Inspections Workshop, FDAnews Third Annual Inspections Summit, Bethesda, Maryland, October 15-17, 2008
  • "Assessing Value: Identifying European and U.S. Regulatory Issues to Discover Hidden Issues as Part of the Due Diligence Process," Teleseminar, May 21, 2008
  • Moderator for "FDA's Center for Biologics Evaluation and Research - Safety Initiatives," Food and Drug Law Institute Annual Meeting, Washington, DC, March 26-27, 2008
  • "FDA Inspection and Enforcement" at the American Society for Quality and FDA sponsored conference "Meeting the Compliance Challenge: Issues in Pharmaceuticals and Devices; Legal Issues Before, During and After Inspections," February 20, 2008
  • "Responding to 483s and Warning Letters: Strategies for High-Stakes Communications," FDAnews Audioconference, March 27, 2007
  • "Introduction to Drug Law and Regulation: Regulation of Drug Manufacturing; Understanding How FDA Regulates the Drug Industry: Violations and Enforcement; Manufacturing/Inspections; and Recent Developments," Food and Drug Law Institute, Washington, DC , November 6-7, 2006
  • "FDA Boot Camp Marketing & Promotional Considerations for Devices," American Conference Institute, September 18-19, 2006
  • "Food Regulation & Litigation Addressing Confidentiality Issues in Food Litigation and Compliance Efforts," American Conference Institute, September 13-14, 2006
  • "Advertising, Promotion & Labeling Conference Drug, Device and Health Care Enforcement Actions," Regulatory Affairs Professional Society Meeting, Denver, CO, May 1-2, 2006
  • "North Central Association of Food and Drug Official," Drug-Device Education Conference, April 25-26, 2006
  • "Minimizing Litigation Risks in 2006 A Strategic Briefing on Medicare Parts B & D and Minimizing & Managing the Whistleblower Phenomenon Federal Government Enforcement Activities Health Care Industry," McGuireWoods, March 9, 2006
  • "Food Regulation and Litigation - Achieving Commercial Success in the Face of Food Regulation & Litigation," American Conference Institute, Orlando, FL , January 19-20, 2006
  • "FDA Criminal Investigations: Regulatory Options," Executive Briefing, Gerson Lehrman Group, New York, NY , November 10, 2005
  • "Understanding Liability as a Regulatory Professional," Thompson Audio Conference, September 27, 2005
  • "Office of the Inspector General Are Device Companies Next? Background & Overview," Regulatory Affairs Professional Society Annual Meeting, Baltimore, MD , October 16-19, 2005
  • "Understanding Liability as a Regulatory Professional," Thompson Audio Conference, March 31, 2005
  • "Liability Issues for the Regulatory Professional," Regulatory Affairs Professionals Society West Coast Conference and Exhibition, San Francisco, CA , March 22-24, 2005
  • "Introduction to Drug Law and Regulation: Understanding How FDA Regulates The Drug Industry: Regulation of Drug Manufacturing," Food and Drug Law Institute, Washington, DC , November 4-5, 2004
  • "Liability Issues for the Regulatory Professional," Regulatory Affairs Professionals Society Annual Meeting, Washington, DC , October 10-13, 2004
  • "The Basics of Current Good Manufacturing Practices for Pharmaceuticals," FDA/North Central Association of Food and Drug Officials, November 3, 2003
  • "Understanding and Working with the Food and Drug Administration," FDA/Chicago International Trade Commissioners Association, October 17, 2003
  • "Introduction to Drug Law and Regulation: Understanding How FDA Regulates the Drug Industry," Delegation of the German Bundestag, June 18, 2003; Orion Pharma, February 20, 2003; and Sunstar, Inc., November 21, 2002
  • "Introduction to Drug Law and Regulation: Understanding How FDA Regulates The Drug Industry: Violations and Enforcement," Food and Drug Law Institute, Washington, DC , June 9-10, 2002
  • "FDA Enforcement and Remedies," Regulatory Affairs Professionals Society 2002 Annual Conference and Exhibition, Washington, DC , October 6-9, 2002
  • "Update on IRB Law and Review of the Recent Case Law," American College of Clinical Pharmacology, San Francisco, CA , September 21-23, 2002
  • "483 to Warning Letter to Consent Decree: Avoiding Common Mistakes and Pitfalls - Administrative Inspections Under the Food Drug and Cosmetic Act," Pharmacia Corporation, San Juan, Puerto Rico, August 12-13, 2002
  • "Individual and Corporate Criminal Liability," Rush Presbyterian St. Luke's Medical Center, July 25, 2002
  • "Introduction to Drug Law and Regulation: Understanding How FDA Regulates the Drug Industry," Food and Drug Law Institute, Washington, DC , June 3-4, 2002
  • "Legal Implications of GMP Failures - FDA's Regulatory Options; 483 to Warning Letter to Consent Decree: Avoiding Common Mistakes and Pitfalls," New Jersey Corporate Counsel Association, Whippany, NJ, May 23, 2002
  • "Current GMPs in the Pharmaceutical Industry," University Of Rhode Island/ Pharma Conference Arrangements, Las Vegas, NV , April 18-19, 2002
  • "FDA Enforcement for Research and Beyond," Rush Presbyterian St. Luke's Medical Center, January 31, 2002

 

* Practice within the District of Columbia is limited to matters and proceedings before Federal courts and agencies.