Overview
Lynn Mehler is chair of the Life Sciences Regulatory practice at Paul Hastings and is based in the firm’s Washington, D.C. office. She counsels pharmaceutical, biotechnology and other life sciences clients on FDA and DEA regulatory challenges across the product life cycle. Having spent more than 12 years in the FDA’s Office of Chief Counsel, Lynn’s frontline experience and understanding of the nuances of regulatory obligations and processes enable her to advise clients of all sizes — from precommercial companies to global pharmaceutical powerhouses — on their most business-critical regulatory matters.
Lynn brings particular depth of experience in providing strategic guidance on FDA engagement and advocacy in the approval processes for new drugs and biologics. She also has extensive experience helping clients navigate drug safety issues, including risk evaluation and mitigation strategies (REMS), post-market studies and pharmacovigilance.
Lynn is a leading regulatory authority on the development and marketing of controlled substances. While at the FDA, she served as the primary attorney on all issues related to controlled substances, liaising with DEA and gaining in-depth understanding of both FDA and DEA regulatory processes. Lynn uses this unique insight to develop effective strategies to support clients’ research and development, clinical trials, regulatory approval, product marketing and compliance for controlled substances.
Prior to joining Paul Hastings, Lynn led the Chambers Band 1-ranked Life Sciences and Health Care Industry sector and the Pharmaceutical and Biotechnology regulatory practice at a global law firm.
Accolades
- Band 4: Pharmaceutical/Medical Products Regulatory: Washington, D.C. — Chambers (2025)
- FDA Commissioner’s Award of Excellence
- FDA Commissioner’s Award of Merit
- FDA Outstanding Service Award
Education
- J.D., William & Mary Law School, Order of the Coif, 1997
- B.A., The College of Wooster, Phi Beta Kappa, 1994
Representations
- Represented multiple companies in FDA dispute resolution and the Administrative Hearing process after FDA refusal to approve an NDA or BLA.
- Strategic advisor to sponsors of products for rare diseases or high unmet need in the development of the data package for application submission and engagement with FDA before and during the review.
- Represented multiple innovator companies in the negotiation, development and implementation of REMS.
- Advised pharmaceutical clients in FDA pharmacovigilance inspections throughout the process, from preparation to successful closeout.
- Advised multiple pharmaceutical clients throughout the controlled substances scheduling process, leading to the successful marketing of the product.
- Advised clients on controlled substances compliance obligations, import/export provisions and quotas.
- Represented clients in DEA enforcement actions, including response to an order to show cause and negotiation of settlements.
Matters may have been completed before joining Paul Hastings.