Cathy L. Burgess is a counsel in the firm's Health Care Group. Her practice focuses on regulatory compliance, product risk management, enforcement and policy matters affecting industries regulated by the Food and Drug Administration (FDA).

FDA
Cathy advises clients on a wide range of matters affecting prescription and OTC drugs, biologics, medical devices, foods and cosmetics, and has extensive experience in the area of current good manufacturing practices (CGMPs). In 1992, she served on the defense team in United States v. Barr Laboratories, widely recognized as the leading case on CGMPs. In that litigation, Cathy was first chair for expert testimony on CGMPs and analytical method validation. She has successfully represented prescription drug and medical device clients in significant FDA enforcement matters.

Cathy provides regulatory counsel on investigational new drug applications (INDs), investigational device exemptions (IDEs), good clinical practice, human subject protection and matters regarding institutional review boards. She also provides advice on product approval, pre-approval inspections, manufacturing, distribution and marketing. She conducts due diligence reviews and provides regulatory advice concerning complex corporate transactions. Cathy provides advice on legislative matters affecting FDA regulated entities, assisting in development of legislative strategies, drafting testimony, preparing clients for interviews with committee staff and providing advice on pending legislation.

Product Risk Management
Cathy serves as the key liaison between the Health Care Group and the Product Risk Management Practice. She conducts liability risk assessments for products regulated under the Federal Food Drug and Cosmetic Act (FDCA) and works with clients to identify and analyze potential legal risks associated with their products throughout the product life cycle. Her practice includes advising clients on CGMPs, quality systems, adequacy of SOPs, investigation reports, inspection management, recalls and responding to Form FDA 483s and Warning Letters. She conducts internal investigations and special audits related to FDA compliance. She also assists clients in designing compliance programs, effective internal audit programs and other risk mitigation strategies.

Prior to joining the firm, Cathy was associate general counsel for the American Red Cross, where she served as regulatory counsel for the organization. One of her primary responsibilities was providing legal assistance and strategic advice to Red Cross management and the Board of Governors' Audit Committee on matters related to the Red Cross Amended Consent Decree.

Education
Georgetown University, B.S.F.S., 1982
Catholic University of America, Columbus School of Law, J.D., 1988

Affiliations
Admitted to practice: District of Columbia, U.S. District Court for the District of Columbia

Other Affiliations
AABB
American Health Lawyers Association
Food and Drug Law Institute

Publications
"FDA Debars Food Importer as Tougher Food Safety Legislation Looms," Crowell & Moring Product Risk Management Alert (December 29, 2009). Co-Authors: Cathy L. Burgess, Steven M. Niedelman, John Brew and Jennifer Knight.

"UK and US Focus Efforts on Food Safety," Crowell & Moring Product Risk Management Alert (December 16, 2009). Co-Authors: Cathy L. Burgess and Anne Davies.

"Recent Eighth Circuit Ruling Imposes Affirmative Duty On Generic Drug Manufacturers To Propose Label Changes Or Risk 'Failure To Warn' Lawsuits: Mensing v. Wyeth, Inc., et al.," Crowell & Moring Product Risk Management Alert (December 4, 2009). Co-Authors: Cathy L. Burgess and April N. Ross.

"Unauthorized H1N1 Product Claims Targeted by Federal Agencies," Crowell & Moring Product Risk Management Alert (November 11, 2009). Co-Author: Cathy L. Burgess.

"Legal Risks Affecting Blood Banks," GxP Lifeline, a MasterControl Publication (2009). Author: Cathy L. Burgess.

"Enterprise Risk Management and Pharmaceuticals," John Liner Review, Vol. 23, No. 2 (Summer 2009). Co-Authors: Cathy L. Burgess, Steven M. Niedelman and John Fleder.

"Congress Moving Quickly On Food Safety Legislation," Crowell & Moring Product Risk Management Alert (June 5, 2009). Co-Authors: Cathy L. Burgess, Steven M. Niedelman and Kristina M. Pisanelli.

"For Life Science Companies: Good and Bad Responses to 483s," Master Control Online Newsletter (May 2009). Author: Cathy L. Burgess.

"House Introduces Legislation On Generic Biologics Approval Process," Crowell & Moring Life Sciences/Public Policy Alert (March 12, 2009). Co-Authors: Janet M. MacLeod, Cathy L. Burgess, Karen A. Gibbs, Teresa Stanek Rea, Keith J. Harrison, Christine L. White, and Kristina M. Pisanelli.

"In Wake of Wyeth Pharma Decision, Congressional Democrats Introduce Bills to Nullify Supreme Court's Riegel Medical Device Preemption Ruling," Crowell & Moring Life Sciences & Torts Alert (March 6, 2009). Co-Authors: Karen A. Gibbs, Cathy L. Burgess, Heather L. Hodges and Kristina M. Pisanelli.

"The Obama Administration Stakes Out Positions on Generic Biologics, Hatch-Waxman Settlements and Evergreening in Its First Budget," Crowell & Moring Life Sciences & Torts Alert (March 4, 2009). Co-Authors: Keith J. Harrison, Teresa Stanek Rea, Cathy L. Burgess, Janet M. MacLeod, Christine L. White and Karen A. Gibbs.

"Wyeth v. Levine: U.S. Supreme Court Rules FDA Approval of Label Does Not Provide Pharmaceutical Manufacturer with Complete Preemption Defense to State Failure-to-Warn Claims," Crowell & Moring Life Sciences Alert (March 4, 2009). Co-Authors: Karen A. Gibbs, Heather L. Hodges and Cathy L. Burgess.

"Senate Responds to Peanut Recalls with Bipartisan Food Safety Reforms," Crowell & Moring Product Risk Management Alert (March 4, 2009). Co-Author: Cathy L. Burgess, Kristina M. Pisanelli and Steven M. Niedelman.

"California Appeals Court Ruling May Lead to Direct Liability for Pioneer Drug Manufacturers in Suits Involving Generic Products," The Federal Lawyer (February 2009). Co-Authors: Heather L. Hodges, Cathy L. Burgess and Karen A. Gibbs.

"Watching for Wyeth: High Court Decision Could Have Strong Implications for Medical Device Manufacturers," MX: Business Strategies for Medical Technology Executives (November 2008). Co-Authors: Karen A. Gibbs, Heather L. Hodges and Cathy L. Burgess.

"Recent California Appeals Court Ruling May Lead To Direct Liability For Pioneer Manufacturers In Suits Involving Generic Drugs: Conte v. Wyeth, Inc., et al.," Crowell & Moring Life Sciences & Torts Alert (November 11, 2008). Co-Authors: Cathy L. Burgess, Karen A. Gibbs and Heather L. Hodges.

"Supreme Court Asked To Consider Congressional Staff Report on Eve of Oral Argument in Wyeth v. Levine," Crowell & Moring Life Sciences & Torts Alert (November 5, 2008). Co-Authors: Karen A. Gibbs, Heather L. Hodges and Cathy L. Burgess.

PDA Technical Report, "Out-of-Specification (OOS) Results: Clarification and Recommendations," a White Paper submitted to FDA by the PDA SAB OOS Committee (Fall 2005). Co-Author: Cathy L. Burgess.

"Enforcement and Litigation – Strategies and Initiatives," FDLI Update (January 2004). Author: Cathy L. Burgess.

"Issues Raised by Follow-On Versions of Biologics," FDLI Update (November 2003). Author: Cathy L. Burgess.

"Consent Decrees: Questions and Answers," Journal of CGMP Compliance, 5(1), 74-77 (2000). Author: Cathy L. Burgess.

Chapter 4: Validation of Methods in Pharmaceutical and Biomedical Analysis, Riley, Fell, and Rosanske (1996). Author: Cathy L. Burgess.

"The Ever-Changing Standards of CGMP: United States v. Barr Laboratories, Inc.," Clinical Research & Regulatory Affairs, 10(3), 137-157 (1993). Author: Cathy L. Burgess.

Speeches & Presentations
Food and Drug Law Institute's Conference entitled "Introduction to Drug Law and Regulation: Understanding How FDA Regulates the Drug Industry." Topics: "Violations and Enforcement," (June 23, 2010). "Regulation of Drug Manufacturing," "When FDA Knocks: How to Handle a CGMP Inspection," and "Import/Export Requirements and International Issues." (Washington, D.C., Nov. 6, 2009). Similar presentations at previous FDLI conferences on drug law. (Nov. 21, 2008, Nov. 7, 2006, Nov. 5, 2004, Jun. 10, 2003, Nov. 9, 2001, and Nov. 3, 2000). Faculty Member/Co-Presenter: Cathy L. Burgess.

"GMP Training Documentation: Steps to Prove Compliance," audioconference sponsored by Thompson Interactive (July 22, 2010, Similar presentation on Sept. 9, 2009). Presenter: Cathy L. Burgess.

"Enforcement or Scientific Collaboration? The Brave New World of FDA Risk Assessment," ACH Media (June 17, 2010). Presenter: Cathy L. Burgess.

"Risky Business: New Compliance Challenges for FDA-Regulated Industry," Crowell & Moring Webinar (May 19, 2010). Co-Presenters: Cathy L. Burgess and Steven M. Niedelman.

"cGMPs: Drugs and Biologics (current Good Manufacturing Practices)," ACI FDA Boot Camp (March 2010). Presenter: Cathy L. Burgess.

"Recalls and Withdrawals," ACI's FDA Boot Camp, Boston (September 15-16, 2009). Presenter: Cathy L. Burgess.

"Supplier Control Case Study: Maintaining Quality and Reducing Risk," pre-conference workshop at the Sixth Annual Medical Device Quality Congress: Leading the Way to Better Performance With Quality Systems Compliance (June 3, 2009). Workshop Moderators: Steven M. Niedelman and Cathy L. Burgess.

"GMP Internal Audits: How to Ensure Compliance and Quality," Thompson Interactive Webinar (May 6, 2009). Co-Presenters: Steve M. Niedelman and Cathy L. Burgess.

Workshop on responding to 483s and Warning Letters for the International Pharmaceutical Academy conference on FDA Pre-Approval Inspections (March 6, 2009). Conductor: Cathy L. Burgess.

"A Change is Gonna Come: How Will the New HHS and FDA Affect Pharmaceutical and Medical Device Companies?," Thompson Publishing Audio Conference (January 29, 2009). Co-Speakers: Cathy L. Burgess and Robert Roth.

"Legal Risks for Blood Establishments," 12th Annual FDA and the Changing Paradigm for Blood Regulation, Las Vegas, NV (January 14, 2009). Speaker: Cathy L. Burgess.

"FDA Inspections: Be Ready," Thompson Interactive Audio Conference (January 7, 2009). Speaker: Cathy L. Burgess.

"Responding to 483s and Warning Letters: Strategies for High-Stakes Communications," FDAnews audioconference (October 30, 2008). Co-Presenter: Cathy L. Burgess.

"Crafting Effective Responses to 483s and Warning Letters," for the Second Annual Inspections Summit sponsored by FDA News, Bethesda, Maryland (October 22, 2007). Co-Presenter: Cathy L. Burgess.

"483's and FDA Warning Letters – How to Respond Correctly," for Thompson Publishing Group Audioconference (June 20, 2007). Co-Presenter: Cathy L. Burgess.

"Responding to 483s and Warning Letters," for FDA News Audioconference (March 27, 2007). Presenter: Cathy L. Burgess.

Centers for Biologics Evaluation and Research (CBER) Break-Out Session at the Food and Drug Law Institute (FDLI) Annual Meeting (April 7, 2006). Moderator: Cathy L. Burgess.

American Red Cross Biomedical Services National Quality Meeting on donor incentives, current good manufacturing practices (cGMPs) and how to conduct a Biomedical Regulatory Line (hotline) investigation, Charleston, S.C. (February 15-16, 2006). Presenter: Cathy L. Burgess.

Continuing medical education course entitled "The Scope of Physicians' Duties and Liability Issues," accredited by Johns Hopkins University and conducted with Dr. Anne Eder, Senior Medical Officer, American Red Cross, Washington, D.C. (September 16, 2005). Presenter: Cathy L. Burgess.

"History and Basis for Failure Investigation and Retesting Requirements: Revisiting the Barr Labs Decision," for Barnett International’s Out of Specification (OOS) Test Results conference, Philadelphia, PA (February 19, 2003). Presenter: Cathy L. Burgess.