Xin Tao

Xin Tao is a member of Baker McKenzie's North America Steering Committee for Healthcare & Life Sciences, and heads our US Food and Drug Law Practice. Clients describe Xin as "His dedication to his clients stands out; he goes above and beyond to do whatever we need. He's really pragmatic with his advice too." (Chambers USA Client Interview - 2024). A former research scientist, Xin brings a deep understanding of the complex scientific issues that relate to the US legal compliance and government enforcement issues, enabling him to help clients with all phases of product development, manufacturing, and marketing. As the science and technology continues to evolve, Xin supports our clients to constantly innovate and push the boundaries of what's possible in the world of science. Xin's practice focuses on advising high-growth companies and investors in life science, healthcare, E-commerce, and technology industries globally. As part of the firm's US Government Enforcement Practice, he has represented many global companies during high-stake US government investigations (including actions initiated by the US Congress, U.S. Department of Justice (DOJ), and U.S. Food and Drug Administration (FDA)) around the world. Xin also has a strong track record in US consumer product recall matters, and with a deep understanding of the intricacies involved in navigating the complex and interrelated legal and scientific issues, Xin can creatively and effectively represent companies in these bet-the-company cases. As a seasoned US government regulatory and enforcement counsel, Xin works closely with global companies with novel pharmaceutical, medical device, food, and cosmetic applications that require US government's pre-market approval or clearance and FDA Current Good Manufacturing Practices (cGMP) compliance. Xin has extensive experience advising both emerging and established companies on the strategy with launching and promoting innovative products such as cell-cultured meat, cellular and gene therapy products and AI/ML-enabled medical devices. Xin also draws on his scientific expertise and experience to provide clients with practical regulatory advice regarding compliance with federal and state health care fraud and abuse law, particularly under the federal Anti-Kickback Statute (AKS).

In brief On June 13, 2024, the Supreme Court of the United States (SCOTUS) unanimously held in FDA v. Alliance for Hippocratic Medicine that plaintiff physicians and pro-life medical associations lacked Article III standing to challenge the U.S. Food and Drug Administration’s (FDA) regulation of mifepristone, a prescription drug primarily used in terminating pregnancy. Following the ruling, mifepristone remains available and approved. Also importantly, SCOTUS reasoned that a desire to make a drug less available for others…