Cathy L. Burgess

Compliance

• Counsel to foreign and domestic manufacturing facilities regarding FDA inspections, regulatory meetings, warning letters, import alerts, and consent decrees. This work has included extended on-site support in India, Central Europe, and China.
• Counsel to multinational clients on risk assessment and control strategies for nitrosamine and other genotoxic impurities.  This work has included preparing submissions to regulatory authorities, working with experts in analytical chemistry, cleaning validation, and toxicology, on long term remediations, and preparing executive managers for meetings with regulatory authorities focused on nitrosamine impurities. 
• Advising and counseling domestic and foreign pharmaceutical manufacturers on issues related to data integrity.
• Advising foreign and domestic pharmaceutical manufacturers on the implications of FDA inspection delays.
• Counsel to blood banks and other clients regarding blood product regulatory compliance matters. 
• Counseled on pharmacy compounding and outsourcing facility issues.
• Counseled on new drug applications for marketed unapproved products.

Enforcement

• Negotiated the successful resolution of import alerts and warning letters related to CGMPs, data integrity, and inspection refusal.
• Negotiated an FDA consent decree in a case involving the mass seizure of a generic drug company’s inventory.
• 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.

Cathy Burgess leads the firm’s FDA Compliance and Enforcement Team and FDA practice.

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 and supply chain management. 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. She advises clients on quality system remediation, inspection management, recalls, and responses to Form FDA 483s and warning letters. Cathy also conducts whistleblower investigations, special audits, and due diligence reviews related to FDA compliance. She 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, ranked in The Best Lawyers in America^® in FDA and Food and Beverage Law, and ranked Band 2 in Chambers USA in Pharmaceutical/Medical Products Regulatory. Cathy is a recipient of the FDLI 2023 Distinguished Service and Leadership Award.

Before joining Alston & Bird, Cathy served as associate general counsel for the American Red Cross, where she was responsible for regulatory matters, and served as the Red Cross Office of General Counsel’s representative in negotiations related to the Red Cross amended consent decree.

Bar Admissions

• District of Columbia

Education

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

Memberships