Wendy C. Goldstein, J.D., M.P.H., is a healthcare regulatory and enforcement defense attorney with over 25 years of experience in the healthcare and life sciences ecosystem. Her clients include biopharmaceutical and device manufacturers, payors, pharmacy benefit managers and providers including hospital systems, digital health companies, medical technology companies and other ancillary providers in the healthcare and life sciences space. She also represents private equity and other entities investing in those sectors.

In July 2020, Wendy was appointed by Gov. Andrew Cuomo to serve as special counsel to the New York State (NYS) Commissioner of Health. In this role, she served as a liaison between the governor, the Executive Chamber, the NYS Office of the Commissioner of Health and the NYS Department of Health on key enforcement matters, the legality of COVID-19 pandemic response policy, regulatory programs and COVID-19 vaccine and testing operations. In addition, she conducted internal investigations alleging regulatory noncompliance, resulting in fraud, waste and abuse and defended the NYS Department of Health in enforcement matters initiated by the U.S. Department of Justice, New York State attorney general, NYS Assembly, NYS Joint Commission on Public Ethics (JCOPE) and numerous NYS county and district attorneys.  Wendy served in this role until October 2021.

Previously, Wendy was a partner and sector practice leader at another leading international law firm. She also previously served as a longtime partner and practice leader in the healthcare and life sciences practice of a leading healthcare regulatory law firm where she served on its board of directors.

Wendy advises clients on critical healthcare regulatory and enforcement issues throughout the product life cycle and across sectors, with particular focus on: 

• Counseling clients regarding the sale, promotion, distribution, pricing and reimbursement of pharmaceuticals, biologics and medical devices. Such counsel includes topics relating to fraud and abuse, the Food, Drug and Cosmetic Act (FDCA), the Prescription Drug Marketing Act (PDMA), third party coverage and reimbursement (government and commercial), Medicaid Drug Rebate and other government pricing programs, corporate compliance, health privacy and security (including HIPAA, HITECH Act and state laws), antitrust, Medicare Part D program, transparency laws and state laws regarding licensing, pedigree and other issues;
• Counseling regarding government healthcare program compliance risks, including designing, implementing and assessing the effectiveness of corporate compliance programs; conducting board of directors training; conducting on-site mock reviews and inspections; conducting internal investigations relating to compliance matters; providing self-disclosure counsel; and preparing Office of the Inspector General of Department of Health & Human Services (OIG) advisory opinion requests;
• Drafting and negotiating affiliation agreements, drug rebate agreements, supply chain arrangements, fee-for-service agreements and third-party vendor arrangements; structuring, drafting and negotiating provider relationships in light of federal physician self-referral and kickback laws and state corporate practice of medicine, fee-split and anti-referral laws; conducting health regulatory due diligences;
• Conducting landscape reviews and risk assessments of pending federal and state laws and policy; drafting comments to proposed regulations and providing strategic counsel to management regarding new and novel product and service development and launches;
• Defending life sciences and healthcare companies in all phases of government investigations and inquiries, and negotiating settlement agreements and OIG corporate integrity agreements on behalf of such companies in connection with the resolution of qui tam and other government actions, defending companies in data breaches; and 
• Counseling third-party payors and other providers in connection with the delivery of outpatient prescription drug benefit and specialty drug benefit programs offered under insured (commercial and government) and self-insured products. Such counsel included topics relating to fraud and abuse, reimbursement, coverage, relationships with vendors such as pharmacy benefit managers, wholesalers and dispensers, Medicare Part D, ERISA, corporate compliance, cyber, data and privacy, antitrust and state law issues.

Wendy speaks and writes extensively on issues relating to healthcare regulatory and policy matters, including fraud and abuse, board governance, government pharmaceutical program pricing, corporate compliance, government enforcement activity relevant to the life sciences and managed care industries and healthcare reform. She was a contributing author to the ABA Health Law Section Pharmaceutical Law treatise. Wendy authored “Chapter 8: Federal and State Regulation and Enforcement of Pharmaceutical Manufacturers' Advertising and Promotional Activity” in the 2016, 2015 and 2014 Practicing Law Institute Pharmaceutical Compliance and Enforcement Answer Book. She has served as an adjunct professor of healthcare fraud and abuse at Pace University School of Law. Wendy also has served on several advisory boards for industry publications and legal associations including the New York State Bar Association Committee on Medical Research and Biotechnology and the New York City Bar Committee on Bioethical Issues.

Wendy currently serves on the advisory boards and a board of directors of several nonprofit healthcare associations and educational institutions. She also is actively involved in pro bono activities relating to the pediatric oncology research and other healthcare education and access initiatives. Wendy also has served as an arbitrator with the American Health Lawyers' Association Arbitration Panel and has served as an arbitrator in a number of AHLA matters.

Wendy and her certified therapy dog, Oscar, are active volunteers at Memorial Sloan Kettering Cancer Center and the Ronald McDonald House. Wendy has authored, illustrated and published a children’s book about Oscar’s work as a therapy dog that has received significant accolades. 

Wendy has been selected for inclusion in The Best Lawyers in America (2013-2020). She was also selected by Crain’s New York Business as one of the Leading Women Lawyers in New York City (2018). She has been ranked by Chambers USA as one of America's leading lawyers for healthcare (2008-2019). Wendy was recognized as a leading lawyer in the 2017 Legal 500 United States, for Healthcare Life Sciences. She was recognized as a Life Science Star in LMG Life Sciences in 2012, 2013 and 2015 and was named by LMG as "Attorney of the Year" for Healthcare Pricing and Reimbursement in 2013. Wendy has been consistently named by the New York Super Lawyers - Metro (2006-2020), which cited her among its "Top 100" (2010- 2020) and its "Top 50 Women" (2006, 2007, and 2009-2020). She was named as one of Nightingale's Outstanding Young Healthcare Lawyers in 2007.

• University of Houston Law Center JD, 1995 (health law concentration)
• University of Michigan B.A., Honors College, 1992
• University of Texas Health Science Center MPH, 1995