Cathy L. Burgess

• 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. 
• Advising and counseling domestic and foreign pharmaceutical manufacturers on issues related to data integrity.
• Negotiated the successful resolution of import alerts and warning letters related to CGMPs, data integrity, and inspection refusal.
• Defended a targeted medical device executive in a criminal referral. 
• Negotiated an FDA consent decree in a case involving the mass seizure of a generic drug company’s inventory. 
• Developed medical device company compliance plans and remediation strategies in response to recidivist warning letters. 
• Counseled on a wide range of regulatory compliance matters affecting blood banks. 
• Counseled on pharmacy compounding and outsourcing facility issues. 
• Preparing clients for FDA inspections. 
• Counseled on supply chain management.

Cathy Burgess co-leads Alston & Bird’s Food, Drug & Device/FDA Team. She 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. She is recognized as a leading practitioner for life sciences in Who’s Who Legal. She is ranked in The Best Lawyers in America^© in the area of Food and Beverage Law and Chambers USA in the area of Pharmaceutical/Medical Products Regulatory. 

Before joining Alston & Bird, Cathy served as associate general counsel for the American Red Cross, where she was responsible for regulatory matters.

Bar Admissions

• District of Columbia

Education

• The Catholic University of America (J.D., 1988)
• Georgetown University (B.S.F.S., 1982)

Memberships