Cathy Burgess focuses her practice 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 range of matters affecting prescription and OTC drugs, biologics, medical devices, foods and cosmetics, and has extensive experience regarding current good manufacturing practice (CGMP) regulation.
For products regulated under the Federal Food Drug and Cosmetic Act (FDCA), Cathy conducts liability risk assessments and works with clients to identify and analyze potential legal risks associated with their products throughout the product life cycle.
She advises clients on quality systems, adequacy of SOPs, investigation reports, inspection management, recalls and responses to Form FDA 483s and warning letters.
Cathy also conducts internal investigations and special audits related to FDA compliance and assists clients in designing compliance programs, internal audit programs and other risk mitigation strategies.
Before joining Alston & Bird, Cathy served as associate general counsel for the American Red Cross, where she was responsible for regulatory matters. In this role she provided legal assistance and strategic advice to Red Cross senior management and the board of governors’ Audit Committee on matters related to the Red Cross Amended Consent Decree.
Bar Admissions : District of Columbia
- The Catholic University of America (J.D., 1988)
- Georgetown University (B.S.F.S., 1982)
- American Health Lawyers Association
- Food and Drug Law Institute, in-house training team to FDA
- Food and Drug Law Institute Drugs and Biologics Committee, co-chair, 2012–2015, 2015-2018
- Food and Drug Law Institute Audit Committee
- The Supreme Court of the United States
- The United States District Court for the District of Columbia
- Served as the defense team’s first chair for expert testimony on CGMPs and analytical method validation in United States v. Barr Laboratories, widely recognized as the leading case on CGMPs.
- Negotiation of an FDA consent decree in a case involving the mass seizure of a generic drug company’s inventory.
- Development of medical device company compliance plans and remediation strategies in response to recidivist Warning Letters.
- Advice and counsel regarding supply chain management.
- Regulatory advice, development of a legislative strategy and compliance audits on behalf of a major food client.
Rate : $$$