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Former FDA Legal Counsel Moves to Shook, Hardy & Bacon

by Shook, Hardy & Bacon | Mar 02, 2021

Kaplan_KKansas City, Mo (March 2, 2021) Former Food & Drug Administration 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 she advised the FDA for eight years, and before taking 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, who divides her time between Washington, D.C. and Kansas City. “It is critical for our clients facing litigation to align with our regulatory team to anticipate and address developing legal developments.”

Kaplan counseled FDA Commissioner 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.”

Kaplan was drawn to Shook for its stellar legal reputation and commitment to diversity. Women compose 45 percent of the firm’s Executive Committee, lead six of the firm’s offices and make up a third of practice group leadership.

“Having known Shook lawyers over the years, I’ve always been impressed with its advancement of women lawyers from the top down,” said Kaplan, who was a 2016 Leadership Council on Legal Diversity Fellow. “That was important to me.”

Shook lawyers capitalize on decades of industry experience to solve complex legal challenges related to the development of a product, bringing it to market and post-market enforcement. Shook attorneys have deep experience with the FDA and represents some of the world's best known brands in the agriculture, food and beverage, personal care and pharmaceutical industries. The firm has represented more than 40 FDA-regulated companies as national or regional counsel.

To speak to a Shook attorney, contact Shook Media Relations Manager Heather McMichael, 816.389.0419, 

About Shook, Hardy & Bacon

Founded in 1889, Shook, Hardy & Bacon L.L.P. has 16 offices in the United States and London, with attorneys and professional staff serving clients in the health, science and technology sectors in areas ranging from product liability defense and business litigation to intellectual property prosecution and litigation, environmental and toxic tort, privacy and data security and regulatory counseling.



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