Cathy L. Burgess is a Washington, D.C. partner in the firm’s Health Care Group. Her practice focuses on regulatory compliance, product risk management, enforcement and policy matters affecting industries regulated by the Food and Drug Administration (FDA). Prior to joining the firm, Cathy served as associate general counsel for the American Red Cross, 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 and Risk Management Committee on matters related to the Red Cross Amended Consent Decree.
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.
- 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 a medical device company's compliance plan and remediation strategy in response to a recidivist Warning Letter.
- Advice and counsel on a wide range of regulatory compliance matters affecting blood banks.
- Advice and counsel regarding pharmacy compounding issues
- Preparing clients for FDA inspections.
- Advice and counsel regarding supply chain management.
- Comprehensive CGMP audit of a client with new OTC products and a pending abbreviated new drug application.
- Regulatory due diligence related to the acquisition of two contract packagers on behalf of a repackager of drug products.
- 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.
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April 30, 2013
In the Press
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Cathy Burgess’ comments at a recent conference on “Redefining the ‘c’ in cGMP” were featured on a PharmTech Talk blog post.
June 13, 2012
In the Press
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Cathy Burgess, a Health Care Group partner in the firm’s Washington, D.C. office, was quoted in an article discussing the proposed language redefining current good manufacturing practices (cGMP) included in both versions of omnibus FDA user fee legislation.
June 6, 2012
In the Press
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“The Drugs and Biologics Committee advises FDLI staff in formulating and implementing policies and strategies consistent with FDLI’s mission, relating to program and publications of interest to the drugs and biologics industries. The committee advises staff on the appropriateness of conferences and publications relating to pharmaceutical and biologics by reviewing and commenting on proposals.”
April 25, 2012
In the Press
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Cathy Burgess, a Health Care Group partner in the firm’s Washington, D.C. office, was prominently featured in an FDA Enforcement Manual article discussing the need for compliance measures to assure drug supplier quality.
March 5, 2012
In the Press
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January 5, 2012
In the Press
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December 8, 2011
In the Press
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Cathy L. Burgess has joined the Washington, D.C., office of Alston & Bird as a partner in the firm's expanding food, drug and medical device practice. Ms. Burgess, a former associate general counsel for the American Red Cross, joins the team which Rep. Billy Tauzin (R-LA), the former President of the Pharmaceutical Research Manufacturers Association (PhRMA) and former Chairman of the House Energy & Commerce Committee, recently joined.
March 8, 2011
In the Press
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September 17, 2013
Seminar
Past Events
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December 12-13, 2012
Seminar
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November 9, 2012
Seminar
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September 19-21, 2012
Seminar
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August 23, 2012
Seminar
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June 4-5, 2012
Seminar
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December 15, 2011
Seminar
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December 6-7, 2011
Seminar
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March 16-17. 2011
Seminar
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February 10, 2011
Seminar
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November 8-9, 2010
Seminar
- American Health Lawyers Association
- AABB
- Food and Drug Law Institute
- Drugs and Biologics Committee, Co-Chair, 2012-2013
- Regulatory Affairs Professionals Society
- Member, The Tiffany Circle of the American Red Cross
- In-House Training Team to FDA sponsored by FDLI
- Admitted to practice before:
- The Supreme Court of the United States
- The United States District Court for the District of Columbia