Kathleen Sanzo is the leader of the Morgan Lewis FDA & Healthcare practice and co-chair of the firm’s life sciences industry team. Kathleen centers her practice on regulatory and compliance issues connected to FDA regulated products. She leads and counsels clients on all legal and regulatory issues concerning product development and testing, manufacturing and marketing of prescription, OTC drug, biologic and vaccine products, and orphan drugs; food, dietary supplements, and cosmetic product manufacture, approval, marketing, and distribution; food, drug, and device compliance and enforcement matters; and consumer product issues regulated by the US Consumer Product Safety Commission (CPSC) and state enforcement agencies.
Kathleen advises companies on regulatory pathway strategies, appropriate responses to FDA protocols and complete response letters, dispute resolution, responding to Current Good Manufacturing Practice (cGMP) inspections and deficiencies, including 483s and Warning Letters, as well as day-to-day counseling on marketing and promotion launch, social media, and similar communications, including responses to FDA Untitled and Warning Letters; and similar advice and counsel on food, dietary supplements, and cosmetic products, including various notices and registrations to FDA; recalls and other crisis management; and counseling on consumer product standards and testing, Section 15(b) notices and penalty investigations, as well as product recalls.
A frequent author and co-author on publications related to FDA matters, Kathleen regularly speaks on these issues at industry events. Industry and legal groups have praised her work: Legal Media Group Life Sciences named her the “US Regulatory Attorney of the Year,” “FDA Pharmaceutical Industry Lawyer of the Year,” and a “Life Sciences Star.” Chambers USA has listed her in “America’s Leading Lawyers for Business.”
Kathleen serves as vice-chair of the Consumer Product Regulation Committee of the American Bar Association Section of Administrative Law and Regulatory Practice, and is a member of the Food and Drug Law Institute’s Medical Products Committee.
She is a board member of INMED Partnerships for Children.
Emerging biotech companies relating to product pathway status (e.g., NDA vs. 505(b)(2)s, Orphan status, fast track, etc.)
A startup company on response to Complete Response Letters
A major pharmaceutical company on a global cGMP 483 response and resulting audit
A major pharmaceutical company on supply chain controls and audits
A major research entity on investigation of CRO and clinical trial deficiencies
A startup biopharmaceutical company on the regulatory and commercial issues in the manufacture of cell therapies
Multiple storage companies concerning the regulatory requirements for cell and tissue-based products
A startup OTC and dietary supplement company with innovative delivery of products
A major dietary supplement company concerning manufacturing and product claims and false advertising litigation
A global company in negotiation of an FTC concern decree on dietary supplement and medical food products
A global company in settlement of multiple investigations concerning defect reporting to CPSC
Duke University, 1979, A.B.
Emory University School of Law, 1982, J.D.
The George Washington University Law School, 1985, LL.M.
District of Columbia
Awards and Affiliations
Recipient, FDLI Distinguished Service and Leadership Award, Food and Drug Law Institute (2021)
Ranked, Life Sciences: Regulatory/Compliance, USA, Chambers Global (2020)
Ranked, Life Sciences: Regulatory/Compliance, Nationwide, Chambers USA (2018, 2019, 2022)
Ranked, Healthcare: Pharmaceutical/Medical Products Regulatory, District of Columbia, Chambers USA (2018–2022)
Ranked, Chambers USA: America's Leading Lawyers for Business (2009–2017)
Recommended, Industry Focus - Healthcare - Life Sciences, The Legal 500 US (2017–2022)
Member, Food and Drug Law Institute’s Medical Products Committee (2021)
Vice-Chair, American Bar Association, Section of Administrative Law and Regulatory Practice, Consumer Product Regulation Committee
Member, Law360 Life Sciences Editorial Advisory Board (2016)
Recognized, FDA Law, Washington, DC, The Best Lawyers in America (2011–2020, 2022, 2023)
Top Woman Lawyer, Best Lawyers (2016, 2017)
Recognized, Life Sciences–Regulatory, Who’s Who Legal (2015–2018)
Recognized, Food and Drugs, Washington, DCSuper Lawyers (2014–2015)
Life Sciences Star, FDA (2012–2015), Regulatory (2016–2022), LMG Life Sciences
US Regulatory Attorney of the Year, LMG Life Sciences (2014)
FDA Pharmaceutical Industry Lawyer of the Year, LMG Life Sciences (2013)
Recognized, FDA & Pharmaceutical in the PLC Life Sciences Multi-Jurisdictional Guide (2015)
Recognized, Regulatory in the PLC Life Sciences Multi-Jurisdictional Guide (2012)
Recognized, Regulatory (Medical Devices) in the PLC Life Sciences Multi-Jurisdictional Guide (2012)
Recognized, Government Enforcement and Investigations in the PLC Life Sciences Multi-Jurisdictional Guide (2012)
Named, International Who's Who of Life Sciences Lawyers 2010
Top Lawyers: Food and Drug, Washingtonian Magazine (2011–2020)