WASHINGTON, DC, June 1, 2023: Morgan Lewis continues to strengthen its regulatory capabilities and roster of former government officials with former US Food and Drug Administration (FDA) Director of the Office of New Drug Policy Maarika Kimbrell. As a senior regulatory and policy official at the FDA, Maarika co-founded and established the Office of New Drug Policy for the Center for Drug Evaluation and Research (CDER), served as deputy chief of staff to former FDA Commissioner Scott Gottlieb, and held several other positions at the agency. Maarika is joining Morgan Lewis as a partner resident in Washington, DC, and in returning to private practice, she will counsel pharmaceutical and biotech companies on regulatory matters.
“Maarika has shaped FDA policy on a broad array of issues impacting the regulation of biomedical products, including accelerated approval and other expedited programs, the granting of market exclusivities, and the agency’s response to the COVID-19 public health emergency,” said Firm Chair Jami McKeon. “Her deep FDA regulatory capability across the lifecycle of drugs and biologics, coupled with her sophisticated understanding of the life sciences industry, will be important in supporting our clients that seek growth and development opportunities in this complex industry.”
Maarika served in a number of roles at the FDA over eight years. Most recently, she was principally in charge of shaping policy impacting the regulation of innovator biomedical products, including drugs and biologics, and she spearheaded an office of three dozen multidisciplinary staff, including physicians, lawyers, regulatory affairs experts, and other staff. In that role, she advised on legal, regulatory, and scientific policy issues arising out of the new drug regulatory program, from early drug development to application review and approval, to post-marketing regulation of biomedical products.
Maarika also served as deputy chief of staff and a principal advisor to former FDA Commissioner Scott Gottlieb on policy matters, including with respect to drug products, drug pricing, and access, and she held several earlier positions at the agency focused on policy and regulatory issues arising in connection with the development and regulation of generic drugs.
Prior to joining the FDA, Maarika spent more than a decade in private practice at two other large law firms, where she advised life sciences industry companies on the development, manufacture, and marketing of small molecule, biologic, and device products across their lifecycles, with a focus on structuring and negotiating complex commercial transactions.
“With Maarika’s valuable, senior-level tenure at the FDA during a time of significant change in drug regulation and discovery, including approvals of novel innovative therapies and biosimilars, and her work with former Commissioner Gottlieb, she will be a tremendous asset to our dedicated FDA practice,” said Kathleen Sanzo, leader of Morgan Lewis’s FDA and healthcare practice. “Her ability to distill and provide insight into complex scientific, regulatory, and legal issues to develop strategic solutions to multifaceted global issues will be key in helping our clients stay on top of and respond to developments that impact their businesses.”
Morgan Lewis continually tops Modern Healthcare’s Largest Healthcare Law Firms list, and was recognized for the second consecutive year as one of Law360’s 2022 Practice Groups of the Year for Healthcare. Maarika’s addition follows the arrival of veteran healthcare partner Amy Magnano and associate Michael Madderra, who arrived in our Seattle office in May 2023.