Former FDA Regulatory Counsel Jessica Gayle Tierney Joins Thompson Hine in Washington, D.C.

Date: October 06, 2021

Publication: Thompson Hine LLP

Thompson Hine LLP is pleased to announce that Jessica Tierney has joined its Product Liability Litigation practice in Washington, D.C. as senior counsel. Her experience includes working at the U.S. Food and Drug Administration (FDA) in its Center for Drug Evaluation and Research (CDER) and its Center for Tobacco Products (CTP).

Tierney comes to the firm with 10 years of FDA regulatory experience and the perspective to share best practices and insight into the regulatory process, which have become particularly important as the country continues to grapple with COVID-19 and industries look to Big Law for guidance in navigating current public health issues. Prior to public practice, Tierney was a lobbyist with two large D.C. firms.

At the FDA, Tierney focused on tobacco litigation, government contracts, and drug regulation. In her most recent role at CDER’s Office of Regulatory Policy, she worked with companies and their lawyers to navigate the drug approval and related processes. She drafted regulations, guidance, and policies related to COVID-19, Over-The-Counter monograph reform, pediatric drug products, exclusivity matters, and drug compounding. As a Branch Chief with CTP’s Office of Compliance, Tierney led a large team of lawyers working on government contracts and various litigation documents related to FDA compliance and enforcement.

Throughout her government tenure, she focused on making government processes more streamlined and efficient. “I found a similar culture at Thompson Hine, as the firm is committed to providing clients with efficient and transparent legal services,” said Tierney of her move to the firm.

Tierney, who participated in developing drug regulations and guidance and regularly advised interested stakeholders on the Food Drug and Cosmetic Act while at the FDA, is well-positioned to help companies achieve their regulatory goals and can quickly discern any issues that may slow down that process, including outside industry communications, positioning, and submission concerns. In addition, her background in lobbying and advocacy enables her to help clients navigate the agency in a thoughtful, transparent way.

“I look forward to helping clients comply with FDA regulations and demystifying the agency and its policies and procedures. I strongly believe that partnership with industry is necessary to produce the best public health solutions, particularly in the food and drug space,” she said.

Tierney is a welcome addition to Thompson Hine’s Product Liability Litigation practice. “Having held high-level positions with both CTP and CDER, Jessica can help our clients navigate the FDA by providing an inside perspective into what material is relevant and required by various agencies,” said David A. Wilson, partner-in-charge of the firm’s Washington, D.C. office.

She received her J.D. from The Catholic University of America Columbus School of Law and her B.A. from Boston College. She is not admitted in the District of Columbia and admitted only in Virginia. Her practice supervised by principals of the firm.

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