Cathy L. Burgess

• Advising and counseling 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.
• Assisted with the submission of an Investigational New Drug (IND) application on behalf of the developer of a SARS-CoV-2 vaccine. Alston & Bird’s work included a protocol review, as well as advice regarding the delivery system for the vaccine and assistance addressing FDA questions regarding the application.
• Advising numerous companies regarding blood plasma products and related regulatory and health and safety concerns.
• Advising foreign and domestic pharmaceutical manufacturers on the implications of FDA inspection delays as a result of the coronavirus.
• Advising commercial manufacturers seeking to develop diagnostic test kits and personal protective equipment for health care workers.
• 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.
• Provided advice and counsel on drug and medical device regulation, as well as development of preparedness strategies and crisis communications, related to the SARS and H1N1 influenza pandemics.
• Provided advice and counsel regarding FDA Emergency Use Authorizations.
• 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 leads the firm’s FDA Compliance and Enforcement Team and co-leads the firm’s 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. 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 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, ranked in The Best Lawyers in America© in the areas of FDA and Food and Beverage Law, and ranked Band 2 in Chambers USA in the area of Pharmaceutical/Medical Products Regulatory. Cathy was named Lawyer of the Year in Food & Beverage Law for 2020 by Best Lawyers.

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