LIFE CYCLE FIRMS
SPONSORED BIOGRAPHIES
GARY YINGLING MORGAN LEWIS 1111 Pennsylvania Ave., NW Washington, DC 20004-2541 Tel: 202 739 5610 Email: [email protected] Web: www.morganlewis.com MORGAN LEWIS 1111 Pennsylvania Ave., NW Washington, DC 20004-2541 Tel: (202) 739 5887 Email: [email protected] Web: www.morganlewis.com
DONNA LEE YESNER
Donna Lee Yesner is a partner in Morgan Lewis’s FDA Practice. Ms. Yesner focuses her practice on pharmaceutical and medical device pricing, and counsels on public healthcare and government contracting issues. Ms. Yesner regularly advises on Medicare and Medicaid coverage, reimbursement, and compliance issues affecting life sciences organizations. These issues include drug and device coverage, pricing, Medicaid Drug Rebate Program price reporting, and coding, claims and cost report submission and appeals. Ms. Yesner has experience in the acquisition and reimbursement of federal healthcare supplies and services, particularly Department of Veterans Affairs, Department of Defense, and Department of Health and Human Services; compliance with laws and regulations governing the Medicaid, Medicare, Tricare, and the 340B drug discount programs, debarment and public policy affecting these programs; and healthcare fraud. Ms. Yesner is a co-chair of the ABA Public Contracts Section Health Care Contracting Committee and is counsel to the Coalition for Government Procurement Health Care Committee. In 2006, she won a case in the US Court of Appeals on behalf of the Coalition, saving the pharmaceutical industry more than a billion dollars in unlawful Tricare rebate claims. Ms. Yesner earned her JD from Catholic University of America, Columbus School of Law in 1983 and her MA in art history from the University of Georgia in 1977. She earned her BA from the University of New Mexico in 1974. Ms. Yesner is admitted to practice in the District of Columbia.
Gary L. Yingling is a partner in Morgan Lewis’s FDA Practice. Mr. Yingling focuses his practice on issues involving the US Food and Drug Administration (FDA) and has also represented clients in matters involving the US Department of Agriculture Food Safety and Inspection Service, the Environmental Protection Agency, the Consumer Product Safety Commission, the Federal Trade Commission, and various states. His clients have included individuals, partnerships, and corporations in cases involving labeling, importation, regulatory marketing strategy, recalls, seizures, and criminal matters. Mr. Yingling’s work in the food industry involves a variety of matters, including ingredient safety questions and product labeling, and his work in the drug industry ranges from the preparation of Investigational New Drug (IND) applications to product labeling. He also has a particular interest in clinical research, contract research organization, and sponsor matters. Prior to joining Morgan Lewis, Mr. Yingling was a partner in multiple food and drug practices of international law firms, resident in Washington, DC. Before entering private practice, he served as president of the Food and Drug Law Institute for nine years. Earlier in his career, Mr. Yingling served in the FDA’s office of the general counsel for 10 years, first as a trial attorney and later as associate chief counsel for its Bureau of Veterinary Medicine and as the deputy chief counsel for administration. He was also director of the Over-the-Counter (OTC) Drug Review in the Bureau of Drugs for two years. Mr. Yingling received the FDA’s Award of Merit, the agency’s highest award, in 1974 for his legal and administrative work on the OTC Review. Mr. Yingling earned his JD from Emory University School of Law in 1968. Prior to attending law school, he practiced community pharmacy and is a registered pharmacist in Maryland and the District of Columbia. He earned his MS from Purdue University in 1966 and his BS from the University of North Carolina in 1962. Mr. Yingling is admitted to practice in the District of Columbia and before the US Supreme Court and the US District Court for the District of Columbia.
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LMG LIFE SCIENCES 2013