Lois Sheng Liu

Lois is a member of the Firm's Litigation & Government Enforcement Practice Group in the FDA sub-group, based in Washington, DC. Prior to joining Baker McKenzie, Lois worked as an associate for another multinational law firm. As a former pharmacist and a research fellow at a major teaching hospital, Lois has an extensive understanding of various regulatory issues related to clinical research and development, marketing strategy, product approval, and government enforcement activities. Lois represents clients in numerous highly regulated industries, including biologic and pharmaceutical manufacturers, medical device companies, academic medical centers, contract research organizations, pharmacies, and physician groups. Lois guides clients through a wide spectrum of healthcare fraud and abuse issues, FDA regulatory concerns, clinical trial matters, mergers and acquisitions, and federal and state compliance. Lois also offers advice to healthcare providers and investors in the healthcare and life sciences industries concerning transactional affairs, specifically addressing the regulatory risks associated with the federal anti-kickback statue, false claims act, and state corporate of medicine restrictions.

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…