Former FDA Legal Counsel Moves to Shook

Former U.S. Food & Drug Administration (FDA) Associate Chief Counsel Kristin Kaplan joins Shook, Hardy & Bacon, further expanding the firm’s regulatory capabilities. Kaplan has a deep understanding of regulatory issues and the nuances of the government agency after advising FDA for eight years and serving an in-house role at a global leader in animal health.

“Her combined FDA insight and in-house experience make Kristin invaluable as we deepen our regulatory capabilities,” said Shook Chair Madeleine McDonough. “It is critical for our clients facing litigation to align with our regulatory team to anticipate and address developing legal developments.”

Kaplan counseled FDA on a variety of issues, including new animal drug applications stemming from biotechnology and recalls of foods, animal foods and drugs. She later became Deputy General Counsel for one of the world’s largest animal health leaders, where she provided strategic insight on various issues including regulatory, compliance, and health, safety and environment matters. In addition, she provided direct global legal support for the company’s COVID-19 response.

“Given the new Administration and pending announcement of a new commissioner, it’s extremely important that businesses recognize priorities may shift whether that’s enforcement or COVID,” said Kaplan. “I am well-positioned to impart the lessons learned on what resonates with the FDA and what does not.”