(February 4, 2013, Washington, D.C.) – Reed Smith LLP today announced the addition of Tisha Schestopol as FDA and health care counsel in its Life Sciences Health Industry Group (LSHI) in the firm’s Washington, D.C. office. Ms. Schestopol was formerly a senior regulatory attorney at Human Genome Sciences, Inc., which was acquired by GlaxoSmithKline in August.
“We are delighted to bring aboard an attorney with Tisha’s experience in FDA and corporate compliance regulatory matters,” said Carol Loepere, Chair of Reed Smith's LSHI Group. “Her role at Human Genome Sciences provided Tisha great insight into the federal regulatory process and her background in health care regulatory law is broad. We look forward to providing her capabilities to our clients.”
At Human Genome Sciences, Ms. Schestopol provided regulatory and compliance guidance to the company as it pursued commercialization of its first product under a co-commercialization agreement with GlaxoSmithKline. Among her key responsibilities was development of processes to ensure compliance with state and federal transparency laws, including implementation of an aggregate spend tracking system, and management of the company’s obligations under government agreements, including those with Medicare, Medicaid and the Veterans Administration. She also provided leadership on development and monitoring of the corporate compliance program, including establishment of policies and processes related to health care professional interactions, and provided related training to the sales force and other stakeholders. In addition, she advised on sales force compliance with state, local and institutional licensing, registration and credentialing requirements as well as on issues related to advertising and promotion directed at health care professionals and consumers.
“Reed Smith’s uniquely integrated approach to offering health care regulatory and FDA services creates an exceptional platform for serving life sciences industry clients. My recent experience within the industry will complement the firm’s existing expertise. ,” said Ms. Schestopol. “Clients within the highly-regulated life sciences industry need counsel who understand that their issues do not always fall neatly within one silo and who take an integrated approach to their health care regulatory and FDA as well as other issues. Reed Smith’s Life Sciences Health Industry Group is perfectly positioned to offer those integrated services. I’m thrilled to be joining the team.”
Prior to joining Human Genome Sciences, Ms. Schestopol was a member of the FDA and Healthcare Practice Group in the Washington, D.C. office of two different major AmLaw top 50 firms, where she represented health care providers, suppliers and manufacturers, with a focus on pharmaceutical and device manufacturers. In these positions, she assisted clients with the development, implementation and monitoring of health care fraud and abuse and corporate compliance programs, as well as delivered fraud and abuse counseling related to anti-kickback, physician self-referral, beneficiary inducement and false claims laws.
In addition, she assisted and counseled clients with investigations and informal inquiries undertaken by federal and state regulatory and enforcement agencies, including the U.S. Department of Justice, the U.S. Department of Health & Human Services Office of Inspector General, and the Centers for Medicare & Medicaid Services, and related litigation matters, including False Claims Act qui tam matters. She also advised clients on the implementation and monitoring of corporate integrity agreements.
“Tisha has been a part of the District’s health care legal community for some time and her talents are well-known and respected,” said A. Scott Bolden, Reed Smith’s D.C. Office Managing Partner. “The life sciences sector is experiencing considerable growth, and we’re happy she has joined us to expand our FDA regulatory and compliance efforts.”
A 2005 graduate of George Washington University School of Law, Ms. Schestopol worked as a health care industry consultant at Arthur Andersen prior to earning her law degree. She earned an undergraduate degree in business administration from Emory University’s Goizueta Business School in 1997.
She is admitted to the bar in Virginia and the District of Columbia and frequently publishes on health care regulatory topics.
About Reed Smith
Reed Smith is a global relationship law firm with more than 1,700 lawyers in 25 offices throughout the United States, Europe, Asia and the Middle East. Founded in 1877, the firm represents leading international businesses, from Fortune 100 corporations to mid-market and emerging enterprises. Its lawyers provide litigation and other dispute resolution services in multi-jurisdictional and other high-stakes matters; deliver regulatory counsel; and execute the full range of strategic domestic and cross-border transactions. Reed Smith is a preeminent advisor to industries including financial services, life sciences, health care, advertising, technology and media, shipping, energy and natural resources, real estate, manufacturing, and education. For more information, visit reedsmith.com.
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