Wendy C. Goldstein leads the firm's Health Care & Life Sciences Regulatory practice.
Ms. Goldstein concentrates in healthcare fraud and abuse and government health care program matters relevant to manufacturers, payors and other ancillary providers in the health care life sciences space. She also represents those entities that invest in such concerns. Specifically, she is involved with:
- Counseling clients regarding the research, manufacture, sale, promotion, distribution, pricing and import/export 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 and state laws), antitrust, Medicare Part D program, transparency laws and other state law issues;
- Counseling regarding government health care program compliance risks, including designing, implementing and assessing the effectiveness of corporate compliance programs; conducting board of directors training; 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 co-promote agreements, drug rebate agreements, supply chain arrangements, fee-for-service agreements and third-party vendor arrangements;
- Conducting health regulatory due diligences;
- Defending pharmaceutical manufacturers in all phases of government investigations and inquiries, and negotiating settlement agreements and OIG corporate integrity agreements on behalf of manufacturers in connection with the resolution of qui tam and other government actions, defending companies in data breaches;
- Counseling third-party payors 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 includes 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, privacy, antitrust and state law issues.
Prior to joining Cooley, Ms. Goldstein served as a partner in the New York office of a leading law firm specializing in, among other practices, health care and life sciences where she was the chair of the firm's Health Care and Life Sciences Practice Steering Committee and the Pharmaceutical Industry Health Regulatory Practice Group.
Ms. Goldstein speaks and writes extensively on issues relating to fraud and abuse, board governance, government program pricing, corporate compliance, government enforcement activity relevant to the life sciences and managed care industries and health care reform. She is a contributing author to the ABA Health Law Section Pharmaceutical Law treatise. Ms. Goldstein authored Chapter 8: Federal and State Regulation and Enforcement of Pharmaceutical Manufacturers' Advertising and Promotional Activity in the 2015 and 2014 Practising Law Institute Pharmaceutical Compliance and Enforcement Answer Book. She has served as an adjunct professor of health care fraud and abuse at Pace University School of Law. Ms. Goldstein 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.
Ms. Goldstein serves on the board of directors of several non-profit health care associations, and educational institutions. She also is actively involved in pro bono activities relating to the pediatric oncology research and other health care education and access initiatives.
Ms. Goldstein has been ranked by Chambers USA as one of America's leading lawyers for health care (2008 to 2015). She was selected for inclusion in The Best Lawyers in America (2013-2016) and in New York Super Lawyers - Metro (2006 to 2015), which cited her among its "Top 100" (2010 to 2015) and its "Top 50 Women" (2006, 2007, and 2009-2015). Ms. Goldstein was also selected as a Life Science Star in LMG Life Sciences 2012, 2013 and 2015 and was named by LMG as "Attorney of the Year" for Healthcare Pricing and Reimbursement in 2013. She was recognized as a leading lawyer in the 2012 Legal 500 United States, in the Healthcare Insurer category. She was named as one of Nightingale's Outstanding Young Healthcare Lawyers in 2007.
- University of Houston Law Center
- University of Texas Health Science Center
- University of Michigan
BA, 1992, Honors College