BakerHostetler Continues to Build FDA Practice With Attorney Hire in Washington, D.C.
8/19/2013 12:04:52 PM
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Washington, D.C., August 19, 2013 — BakerHostetler is pleased to announce that Lee H. Rosebush has joined the firm as Counsel in the Washington, D.C., office. Dr. Rosebush focuses his practice on FDA, regulatory, compliance and enforcement issues pertaining to pharmaceuticals, biologics and medical devices. Dr. Rosebush is a registered pharmacist with over a decade of experience in the pharmacy and pharmaceutical industry, including experience working for national retail pharmacies, institutional pharmacies, a Fortune 500 drug company and the U.S. Food and Drug Administration. Previously, Dr. Rosebush was with Morgan Lewis.
As a member of the FDA Practice Team, Dr. Rosebush advises pharmaceutical, medical device and dietary supplement manufacturers in matters relating to FDA regulatory compliance, including governance in the drug naming process, clinical trial, marketing, promotion and advertisement and approval process. He also assists clients with pharmacy law and healthcare-related issues stemming from Medicare, Medicaid and state regulatory requirements. This includes state licensing requirements for healthcare providers, with an emphasis on pharmacies, as well as drug and device manufacturers and distributors. In addition to his healthcare-related work, he advises private equity, public and private companies in transactional matters.
“We are excited to welcome Lee to our national FDA practice,” said Jeffrey H. Paravano, managing partner of BakerHostetler’s Washington D.C. office.
“Lee is a terrific addition to our FDA team with his experience helping clients navigate medical device and pharmacy law issues,” said Lance L. Shea, leader of BakerHostetler’s national FDA Practice Team.
Dr. Rosebush received his M.B.A. and M.S. in finance from Indiana University’s Kelly School of Business. He received his J.D. from Case Western Reserve University School of Law. Dr. Rosebush obtained his Pharm. D. (Doctor of Pharmacy) from Purdue University. He is admitted to practice in the District of Columbia, Illinois, and Connecticut and is a member of the U. S. Supreme Court Bar and the U.S. Patent and Trademark Office Bar. He is a member of the American Health Lawyers Association, the Illinois State Bar Association, the American Society of Pharmacy Law and the Ohio Pharmacist Association.
BakerHostetler’s FDA Practice Team is based in Washington, D.C., and assists clients in the pharmaceutical, medical device and other life science industries regulated by the FDA, DEA, EPA and other federal or state agencies. The team also counsels clients in litigation and compliance matters arising from regulatory decisions or involving cutting-edge, scientific evidence.
The Team has a wealth of capabilities for successfully handling product efficacy, safety, promotion, regulatory compliance and litigation matters at all stages of product development, approval, manufacturing and marketing. The group’s litigation and compliance capabilities span administrative, advertising and products liability matters of all sizes.
The FDA Practice Team is led by Partner Lance Shea, who focuses his practice on product efficacy and safety issues that are resolved through regulatory science advocacy. Such issues arise across the entire product lifecycle (e.g., technology acquisition, premarketing approval, clinical trial design and interpretation, manufacturing, advertising, adverse event analysis and reporting, compliance and products liability litigation). Routinely, he advises on strategies that improve clients’ presence in the marketplace and posture in litigation through development, interpretation and advocacy of regulatory science. Currently, he represents drug, medical device and food companies, as well as academic medical centers. In addition to legal practice, Lance is an Adjunct Professor in the University of Maryland Francis King Carey School Of Law and in the University of Maryland School Of Pharmacy.
The Team also draws from the experience of Francis Palumbo, Ph.D., Esq., who regularly collaborates with the firm as an independent contractor. He is the Executive Director of the University of Maryland Center on Drugs and Public Policy and Professor in the University of Maryland School Of Pharmacy where, as one of his duties, he teaches pharmacy law. Also, he teaches FDA law as an Adjunct Professor in the University of Maryland Francis King Carey School Of Law. Dr. Palumbo has valuable longstanding experience in broad areas of pharmacy and FDA law, such as controlled substances regulation, state pharmacy practice regulation, compounding pharmacy regulation and regulatory decision-making at the FDA. He is a past president of the American Society for Pharmacy Law and is on the editorial advisory board of the Food and Drug law Journal. He is a member of both the Maryland and District of Columbia Bars.
The Team also relies on the experience of Janet Kwiatkowski, M.B.A., M.S., RAC, who regularly collaborates with the firm as an independent contractor. As a Regulatory Affairs and Compliance Executive, she brings the perspective of a non-lawyer consultant to clients regulated by the FDA and similar agencies in other countries. Her experience with medical device clients is wide-ranging, including pre-market activities, dossier generation and submission and post-market activities for medical devices and in vitro diagnostic devices, including cardiovascular, obstetrics/gynecology, gastrointestinal/urology, general and plastic surgery, radiology, immunology, hematology and microbiology. Additionally, she works with clients in bioscience and biopharmaceutical manufacturing industries and has strong experience with international matters.
BakerHostetler is among the nation's 100 largest law firms with more than 800 attorneys coast to coast, delivering the highest quality legal counsel on the most complex and critical issues facing clients today. The firm has offices in Chicago, Cincinnati, Cleveland, Columbus, Costa Mesa, Denver, Houston, Los Angeles, New York, Orlando and Washington, D.C. Its five primary practice groups are Business, Employment, Intellectual Property, Litigation and Tax. For more information, visit www.bakerlaw.com
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