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.
• Successfully defended a targeted medical device executive in a criminal referral.
• 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 on a wide range of regulatory compliance matters affecting blood banks.
• Advice and counsel regarding pharmacy compounding and outsourcing facility issues.
• Preparing clients for FDA inspections.
• Advice and counsel regarding supply chain management.
• Comprehensive cGMP audits.
• Regulatory due diligence in the prescription and OTC drug, pharmacy compounding and medical device areas.
• Advice and counsel regarding new drug applications for marketed unapproved products.
• Regulatory advice, development of a legislative strategy and compliance audits on behalf of a major food client.
• Assisted a medical device client in responding to FDA import holds and detentions.
• Advice and counsel to the principal investigator of an investigational device whose research was suspended pending resolution of a Warning Letter.
• Advice and counsel regarding Material Review Board decisions.
• Drafting testimony and responses to questions for the Committee on Energy and Commerce Subcommittee on Oversight and Investigations.

 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. She is recognized as a leading practitioner for life sciences in Who’s Who Legal. She is also 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. 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

Education

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

Memberships