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FDA Vet Brings Regulatory, Compliance Expertise To Sidley

Sidley Austin LLP has recently bolstered its regulatory and compliance capabilities with the addition of Michael Varrone, a seasoned attorney from the U.S. Food and Drug Administration (FDA). Joining Sidley's Washington, D.C., office as counsel, Varrone's expertise spans a variety of FDA-regulated areas including drugs, biologics, medical devices, food, cosmetics, and tobacco.

FDA Vet Brings Regulatory, Compliance Expertise To Sidley: A Rich History with the FDA

Michael Varrone’s illustrious 21-year career at the FDA culminated in his role as a senior adviser to the chief counsel. His extensive experience and deep understanding of regulatory frameworks make him a prized addition to Sidley’s food, drug, and medical device practice. His recruitment follows the hiring of Jay Jariwala, another former FDA attorney, who joined Sidley as its senior director of regulatory compliance in the summer of 2022.

“I’ve always been interested in public health and product innovation," Varrone shared with Law360 Pulse. "I wanted to help ensure that American consumers receive innovative, safe, and effective medical products.”

FDA Vet Brings Regulatory, Compliance Expertise To Sidley: Legislative and Policy Impact

During his tenure at the FDA, Varrone was instrumental in shaping FDA-related policy and legislation, particularly during the COVID-19 pandemic. His roles included acting deputy general counsel in the U.S. Department of Health and Human Services' Office of the General Counsel and health policy adviser to the U.S. Senate Committee on Health, Education, Labor, and Pensions.

Notable Legal Contributions

Varrone's expertise is not just in policy but also in enforcement. He was involved in significant legal cases, including the one against Blue Bell ice cream, which resulted in the company pleading guilty to charges linked to a listeriosis outbreak and being fined over $17 million. He also worked on a case against operators of a synthetic drug business in Kansas, highlighting his commitment to protecting public health.

Looking Forward

“Mike is a key addition to our global life sciences team," said Sharon Flanagan, a member of Sidley's management and executive committees. "His expertise in FDA law and strong track record on complex enforcement, compliance, regulatory, and litigation matters further strengthens our deep bench of FDA knowledge.”

With his background, Varrone aims to continue his dedication to high-quality, safe, and effective products, supporting companies in navigating the complexities of FDA regulations.