Press Release January 28, 2022

Alston & Bird Adds Former FDA Associate Chief Counsel Alexandra Marzelli as Counsel in Washington, D.C.

Alston & Bird has expanded its health care and life sciences regulatory and compliance capabilities with the addition of counsel Alexandra Marzelli, former associate chief counsel at the U.S. Food and Drug Administration (FDA). Based in the firm’s Washington, D.C. office, Marzelli joins Alston & Bird’s Health Care and FDA/Food, Drug & Device Groups, where she will advise clients on the FDA’s complex approval process and regulatory compliance for prescription and over-the-counter drugs, biologics, medical devices, food ingredients, and other products regulated by the agency.
“Alexandra brings deep knowledge and experience with the FDA from one of the most critical and challenging times in the agency’s history,” said Cathy Burgess, Alston & Bird partner and co-leader of its FDA/Food, Drug & Device Team. “There is simply no substitute for the insight that Alexandra brings as a former top FDA attorney. Her thorough understanding of the complex regulatory issues at play in health care, life sciences, and other related industries will be indispensable to our clients as they seek practical and business-minded solutions to the challenges they face.”
Marzelli spent five years at the FDA, beginning in 2017. During her tenure, she focused on generic and biosimilar drugs, combination products, user fee appeals, and promotional labeling and advertising matters. She also provided technical assistance to Congress on legislation.
Amid the pandemic, Marzelli served on the FDA Office of the Chief Counsel’s COVID-19 response team, where she managed requests to the FDA for legal advice on COVID-19 matters. 

Before joining the FDA, Marzelli served as senior counsel at global medical technology company Becton, Dickinson and Company (BD). In this role, she counseled on promotional claim substantiation, supervised internal investigations, and advised on current good manufacturing practice compliance.
Prior to her work at BD, Marzelli was  in private practice with two Washington, D.C. law firms, where she advised on litigation and FDA regulatory matters.
“Alexandra’s FDA service, coupled with her attorney experience in-house at BD and in private practice, gives clients significant value in navigating the FDA’s complex and evolving regulatory landscape,” said Marc Scheineson, Alston & Bird partner and co-leader of its FDA/Food, Drug & Device Team. “Given the high stakes of the FDA’s product approval decisions, Alexandra will be a trusted adviser and advocate that every client will want in their corner.”
Marzelli is the most recent addition to Alston & Bird’s deep bench of health care attorneys with government experience. Other recent arrivals include senior policy advisors James “JP” Paluskiewicz, former Republican chief health counsel for the House Committee on Energy and Commerce’s Subcommittee on Health, and Neleen Rubin, past Democratic member of the Senate Finance Committee health policy team; counsel Jane Lucas, former White House special assistant to the President for legislative affairs; and partner Elinor Hiller, a former senior advisor to the head of the Centers for Medicare and Medicaid Services.
Media Contact
Alex Wolfe
Communications Director

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