Maarika L. Kimbrell
Maarika Kimbrell focuses her practice on the regulation of drug and biologic products by the US Food and Drug Administration (FDA), advising clients on complex regulatory and related commercial issues across the development and regulatory product lifecycle. Stemming from her time at the agency, Maarika has a broad and nuanced understanding of the FDA regulatory framework and the challenges facing life sciences companies. Maarika routinely advises clients on mission-critical matters affecting product development strategy, FDA engagement, actions, and enforcement, and regulatory risk. Her practice includes resolving novel and complex regulatory issues before the FDA and representing clients in adversarial contexts involving FDA oversight of medical products.
Maarika advises a broad spectrum of life sciences clients—from multinational pharmaceutical companies to emerging biotech companies, as well as manufacturers, developers, and investors—on high-stakes FDA regulatory matters across the full lifecycle of drug and biologic products. She partners with clients on premarket regulatory and development strategy, clinical trial submissions and compliance, FDA submission planning and meeting strategy, post-approval filings, product recalls, facility inspections, and regulatory exclusivities, vouchers, and other development incentives. Maarika has deep experience advising on biosimilar and generic drug development issues and programs, including matters under the Hatch-Waxman Amendments and the Biologics Price Competition and Innovation Act (BPCIA). She also advises clients throughout emerging and business-critical situations, including FDA enforcement actions, adverse regulatory decisions and product withdrawals, and related crisis management.
Prior to returning to private practice, Maarika spent nearly a decade in senior leadership roles at the FDA, where she focused on cutting-edge policy issues affecting the regulation of drugs and biologics. She served in leadership positions within the Center for Drug Evaluation and Research (CDER) and the Office of the Commissioner and co-founded, built, and most recently led the Office of New Drug Policy. In that role, she provided strategic advice and developed agency-wide policy on a wide range of regulatory issues impacting drug and biologic products across the product lifecycle, from early development and clinical trials through FDA review and approval standards, expedited programs, 505(b)(2) applications, biosimilars, development incentives (including exclusivities and vouchers), post-market regulation, product withdrawals, and user fee programs.
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.
Maarika is a frequent speaker on FDA regulatory issues for the drug and biologics industries and is the editor of the firm’s industry-focused blog, As Prescribed.
