Lois Sheng Liu

Lois advises a broad range of clients across highly regulated industries, including pharmaceutical, biotech, device, food, dietary supplement, and cosmetic companies, distributors, contract research organizations, academic medical centers, hospital systems, and pharmacies.

Lois’s FDA regulatory work covers the full product lifecycle, including clinical research and development, product approval and commercialization strategies, promotional and labeling compliance, post-market regulatory obligations, and responses to government enforcement activities.

Her healthcare regulatory practice focuses on healthcare fraud and abuse laws, including the federal Anti-Kickback Statute, Stark Law, Physician Payments Sunshine Act, and comparable state laws. She also advises on the design and implementation of compliance programs governing patient assistance programs and interactions with healthcare providers, including consulting and advisory arrangements, speaker programs, grants and sponsorships, research collaborations, investment structures, and other provider-facing commercial activities.

In addition, Lois regularly counsels on state healthcare regulatory matters, including state pharmacy law and state corporate practice of medicine restrictions. She helps healthcare and life sciences companies, management services organizations, and investors navigate complex state licensing, ownership, and operational requirements that affect healthcare delivery models and strategic investments. Her expertise guides companies and investors through transactional matters in the healthcare and life sciences space, with a focus on identifying and mitigating the regulatory risks in mergers, acquisitions, and other strategic transactions.

• Advised Lone Star Funds in connection with its acquisition of the Capsules & Health Ingredients division of Lonza Group AG.
• Advised Merit Medical Systems, the NASDAQ-listed global developer, manufacturer and marketer of medical devices used in interventional and diagnostic procedures, on multiple transactions 
• Advised AbbVie on multiple transactions, including its acquisition of Allergan, the acquisition of a clinical stage pharmaceutical company and the acquisition and divestitures of various manufacturing and R&D sites.
• Advised Lotus Pharmaceutical Co. Ltd. in its USD 2.2 billion agreement to acquire 100% equity interests in New Alvogen Group Holdings, Inc., which owns Alvogen US, a fully integrated specialty pharmaceutical company based in New Jersey.
• Advised H.Lundbeck A/S (Lundbeck) on its acquisition of Longboard Pharmaceuticals, Inc. The transaction is valued at approximately USD 2.6 billion equity value and USD 2.5 billion (approximately DKK 17 billion) net of cash.
• Advised Acorda Therapeutics in its asset purchase agreement with Merz Therapeutics for Inbrija, (F)ampyra and related assets of Acorda pursuant to a Section 363 sale.
• Advised Vandemoortele, a leading European family-owned food group, in a strategic partnership with Banneton, a high-quality manufacturer of premium freezer-to-oven croissants, Danishes and pastries in North America.
• Assisted a US publicly traded medical device company in connection with SEC investigation into its marketing and distribution activities by its China subsidiary, providing risk assessment and compliance enhancement recommendations.
• Advised a European major pharmaceutical company on conducting clinical trials and investigator-initiated trials in China.

• American Health Law Association - Member
• Food and Drug Law Institute - Member