Melissa K. Mannion

Melissa Mannion is a seasoned regulatory attorney and pharmacist with more than a decade of governmental experience advancing public health through compliance, enforcement, and policy development and implementation. She has in-depth experience as a strategic counselor who is resourceful and creative in identifying solutions that have firm legal and regulatory foundations and who supports scientific advancements to drive progress and productivity.

Prior to joining Jones Day in 2025, Melissa served with the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). During this time she represented the FDA domestically and internationally on matters related to the development of high-quality generic drugs and the global distribution of human drugs, led agency-wide development of programs under the Drug Supply Chain Security Act, and testified as an expert witness during criminal proceedings involving violations of the Food, Drug & Cosmetic Act (FD&C Act) and other related federal statutes.

Her experience also includes resolving complex regulatory hurdles in support of timely review and approval of abbreviated new drug applications (ANDAs); fostering international regulatory alignment on clinical studies and the development of complex drugs and drug-device combination products; collaborating with international health regulatory agencies to combat the rise of substandard, falsified, and counterfeit medical products; responding to incidents and recalling potentially harmful and ineffective drugs to protect patient safety and secure the integrity of the U.S. drug supply chain; addressing drug import and export compliance challenges; and investigating unlawful sales of prescription drugs on the internet.