Former FDA Investigator, Trusted Healthcare Advisor Joins Barnes & Thornburg

WASHINGTON, D.C. (Aug. 4, 2025) — Continuing the strategic expansion of its nationally recognized healthcare and life sciences team, Barnes & Thornburg has recruited former Food and Drug Administration (FDA) investigator and compliance officer Seth Mailhot as a partner in the firm’s Washington, D.C., office.

With more than two decades spent navigating FDA regulations from both inside and outside the agency, Mailhot offers clients a rare trifecta of technical fluency, insider perspective and business-driven counsel.

“Seth brings invaluable insight into FDA decision-making and how to manage regulatory risk in fast-moving markets,” said Healthcare Industry practice chair John Kelly. “His arrival enhances our ability to deliver practical guidance to healthcare and life sciences clients across the country."

With extensive experience advising clients across the pharmaceutical, biotechnology, medical device, food, and consumer product sectors, Mailhot counsels companies on the full spectrum of FDA regulatory matters, including premarket approvals — 510(k), PMA, NDA, ANDA, IND — GMP and quality system compliance, labeling and advertising review, product recalls and enforcement actions involving the FDA and the Department of Justice (DOJ).

Mailhot also advises on digital health, including the use of artificial intelligence and machine learning algorithms in diagnostic medical devices, state Extended Producer Responsibility (EPR) requirements, California’s Proposition 65 and transactions involving FDA-regulated entities.

“Seth’s arrival reflects our focus on attracting high-impact talent with deep regulatory experience in the D.C. market,” said Office Managing Partner Roscoe C. Howard, Jr. “He’s a strong complement to our national platform.”

Before joining Barnes & Thornburg, Mailhot led FDA regulatory practices, advising clients across a wide range of industries. His earlier experience at the FDA — as an investigator, compliance officer and regulatory researcher — combined with his background in chemical engineering, enables him to provide clear, actionable guidance in complex, scientific, high-stakes regulatory matters.

Mailhot earned his J.D. from New England Law and his B.S. in chemical engineering from the University of Massachusetts Amherst.

With more than 800 attorneys and other legal professionals, Barnes & Thornburg is one of the largest law firms in the country. The firm serves clients worldwide from offices in Atlanta, Boston, California, Chicago, Delaware, Indiana, Michigan, Minneapolis, Nashville, New Jersey, New York, Ohio, Philadelphia, Raleigh, Salt Lake City, South Florida, Texas and Washington, D.C. For more information, visit us at btlaw.com.