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).
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.