Brangan, Suzanne L.

FREDERICK H. BRANDING, RPh, JD, is a Principal Attorney with the Washington, DC law firm of OFW Law and resident in Chicago, IL. He is a registered pharmacist with extensive experience in pharmaceutical, food, drug, medical device, and cosmetic regulatory compliance and enforcement issues. His experience includes 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. Prior to joining OFW Law, Mr. Branding served in private practice with firms in Chicago. He also served as a former 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, Mr. Branding 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. Mr. Branding received his pharmacy and biology degrees from Drake University and his JD from Illinois Institute of Technology Chicago-Kent College of Law. 

A registered pharmacist and attorney, Fred is currently a resident of Chicago, IL.  He has extensive experience in food, drug, device and cosmetic regulatory compliance and enforcement issues. Fred's 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.  

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
November 5-6, 2009
Washington, DC

BEHIND THE COUNTER DRUGS - A MIDDLE CLASS IN    THE UNITED STATES 2008 SYMPOSIUM
National Association of Boards of Pharmacy
December 4-5, 2008
Tucson, AZ

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
November 20-21, 2008
Washington, DC

INSPECTIONS WORKSHOP
FDAnews Third Annual Inspections Summit
October 15-17, 2008
Bethesda, Maryland

     Presented "Assessing Value: Identifying European and U.S. Regulatory Issues to Discover Hidden Issues as Part of the Due Diligence Process," Teleseminar, May 21, 2008

         Moderated "FDA's Center for Biologics Evaluation and Research - Safety Initiatives," at the Food and Drug Law Institute's Annual Meeting, Washington, DC, March 26-27, 2008

         Presented "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

         Presented "Responding to 483s and Warning Letters: Strategies for High-Stakes Communications," FDAnews Audioconference, March 27, 2007

         Presented "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

         Presented "FDA Boot Camp Marketing & Promotional Considerations for Devices," American Conference Institute, September 18-19, 2006

         Presented "Food Regulation & Litigation Addressing Confidentiality Issues in Food Litigation and Compliance Efforts," American Conference Institute, September 13-14, 2006

         Presented "Advertising, Promotion & Labeling Conference Drug, Device and Health Care Enforcement Actions," Regulatory Affairs Professional Society Meeting, Denver, CO, May 1-2, 2006

         Presented "North Central Association of Food and Drug Official," Drug-Device Education Conference, April 25-26, 2006

         Presented "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

         Presented "Food Regulation and Litigation - Achieving Commercial Success in the Face of Food Regulation & Litigation," American Conference Institute, Orlando, FL , January 19-20, 2006

         Presented "FDA Criminal Investigations: Regulatory Options," Executive Briefing, Gerson Lehrman Group, New York, NY , November 10, 2005

         Presented "Understanding Liability as a Regulatory Professional," Thompson Audio Conference, September 27, 2005

         Presented "Office of the Inspector General Are Device Companies Next? Background & Overview," Regulatory Affairs Professional Society Annual Meeting, Baltimore, MD , October 16-19, 2005

         Presented "Understanding Liability as a Regulatory Professional," Thompson Audio Conference, March 31, 2005

         Presented "Liability Issues for the Regulatory Professional," Regulatory Affairs Professionals Society West Coat Conference and Exhibition, San Francisco, CA , March 22-24, 2005

         Presented "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

         Presented "Liability Issues for the Regulatory Professional," Regulatory Affairs Professionals Society Annual Meeting, Washington, DC , October 10-13, 2004

         Presented "The Basics of Current Good Manufacturing Practices for Pharmaceuticals," FDA/North Central Association of Food and Drug Officials, November 3, 2003

         Presented "Understanding and Working with the Food and Drug Administration," FDA/Chicago International Trade Commissioners Association, October 17, 2003

         Presented "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

         Presented "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

         Presented "FDA Enforcement and Remedies," Regulatory Affairs Professionals Society 2002 Annual Conference and Exhibition, Washington, DC , October 6-9, 2002

         Presented "Update on IRB Law and Review of the Recent Case Law," American College of Clinical Pharmacology, San Francisco, CA , September 21-23, 2002

         Presented "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

         Presented "Individual and Corporate Criminal Liability," Rush Presbyterian St. Lukes Medical Center, July 25, 2002

         Presented "Introduction to Drug Law and Regulation: Understanding How FDA Regulates the Drug Industry," Food and Drug Law Institute, Washington, DC , June 3-4, 2002

         Presented "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

         Presented "Current GMPs in the Pharmaceutical Industry," University Of Rhode Island/ Pharma Conference Arrangements, Las Vegas, NV , April 18-19, 2002

         Presented "FDA Enforcement for Research and Beyond," Rush Presbyterian St. Lukes Medical Center, January 31, 2002

Legal Education

Undergraduate Education

Professional Admissions / Qualifications

         Illinois

Court Admissions

         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

Professional Affiliations

         Member, Food and Drug Law Institute

         Member, Regulatory Affairs Professionals Society