Maarika L. Kimbrell

Prior to rejoining private practice, for nearly a decade Maarika held leadership roles focused on cutting-edge policy concerns impacting the regulation of drugs and biologics at the FDA’s Center for Drug Evaluation and Research (CDER) and the Office of the Commissioner. Maarika co-founded, established, and most recently led the Office of New Drug Policy, where she provided strategic advice and developed policies on a wide range of regulatory and policy issues impacting drug and biologic products (including biosimilars) across their lifecycles, including early drug development, clinical trials, drug review processes, approval standards and related expedited programs, 505(b)(2) applications, development incentives such as exclusivities and vouchers, post-market regulation, withdrawals, and related user fee programs. During the COVID-19 public health emergency, Maarika led the development and execution of policies implementing the agency’s emergency use authorities and its strategic response to the emergency in connection with the development and assessment of related therapeutics.

In an earlier role, Maarika served as deputy chief of staff to the FDA Commissioner, advising on policy matters involving drug products, pricing, and access, among other responsibilities. In several earlier positions in CDER, Maarika focused on policy and regulatory issues surrounding the development and regulation of generic drugs in the Office of Generic Drug Policy, including supervising a division focused on the application of the Hatch-Waxman amendments, the Orange Book, and related topics to the review and approval of generic drugs.

Prior to joining the FDA, Maarika spent more than a decade in private practice advising companies in the life sciences industry regarding the development, manufacture, and marketing of medical products across their lifecycles. She focused on structuring and negotiating complex commercial transactions, including intellectual property-focused license and collaboration agreements and other commercial contracts.

• A publicly traded biotechnology company in Administrative Procedure Act (APA) litigation involving FDA and review and approval standards relating to its new drug application
• A multinational pharmaceutical company in connection with an approval-pathway determining Type C meeting response
• A large multinational pharmaceutical company as an FDA regulatory subject matter expert in connection with antitrust claims related to FDA-regulated activities under the Hatch-Waxman framework
• A large pharmaceutical company in connection with APA litigation involving FDA, Hatch-Waxman issues, and proposed follow-on products
• A biotechnology company in connection with strategies related to submission and FDA’s review and consideration of citizen petitions
• A multinational pharmaceutical company in connection with regulatory strategies for a post-approval confirmatory study and related accelerated approval issues
• A publicly traded biotechnology company on navigating the FDA new drug application review process and related regulatory submissions
• Multiple pharmaceutical companies in connection with FDA’s review and assessment of proposed proprietary name, including related appeals
• A consortium and advocacy organization in connection with challenges to FDA rulemaking and related regulatory actions
• A biotechnology company in connection with developing regulatory strategies to address emerging data related to its product and related FDA interactions