Lee H. Rosebush

Associate

Lee H. Rosebush is an associate in Morgan Lewis’s Healthcare Practice. His practice focuses on FDA regulatory, compliance, and enforcement issues pertaining to pharmaceuticals, biologics, and medical devices. Dr. Rosebush has also appeared before state boards of pharmacies and has assisted clients with various issues related to Medicare, Medicaid, and state regulatory requirements, including state licensing requirements, for healthcare providers and pharmacies, as well as drug and device manufacturers and distributors. As part of his practice, Dr. Rosebush regularly provides regulatory counsel to pharmaceutical, medical device, and dietary supplement manufacturers; advises clients in matters relating to FDA regulatory compliance, including governance in the drug naming process, clinical trial, marketing, promotion and advertisement, and approval process; and advises private equity, public, and private companies in transactional matters. In addition, he has authored an amicus brief for a matter before the U.S. Supreme Court.

Dr. Rosebush's recent representative client matters include:

• Represented a mail order pharmacy in its sale of stock to a pair of private equity groups
• Successfully represented a residential treatment center in an administrative Formal Hearing involving an alleged $1.1 million Medicaid overpayment
• Advised private equity groups specializing in healthcare industry in a stock purchase of a worker compensation specialty pharmacy

Dr. Rosebush is a registered patent attorney and a registered pharmacist. Prior to joining Morgan Lewis, he was an associate in the healthcare group of a national law firm. Dr. Rosebush previously worked in Indiana and Ohio as a pharmacist in both hospital and national retail pharmacy settings. He gained regulatory experience at a Fortune 500 drug company and at the U.S. Food and Drug Administration, where he reviewed Orphan Drug Applications in the Office of Orphan Products. In 2004, Dr. Rosebush received a Certificate of Appreciation by the FDA in recognition of his outstanding contributions to the Office of Orphan Products Development. Dr. Rosebush has volunteered as a healthcare provider with "Mission on the Move" in Honduras, where he treated more than 500 patients.

Dr. Rosebush received an M.B.A. and an M.S. in finance from Indiana University's Kelley School of Business in 2010. He received his J.D., with certificates of concentration in both health law and law and technology (intellectual property), from Case Western Reserve University School of Law in 2008. He received his Pharm.D. (Doctor of Pharmacy) from Purdue University in 2005.

Dr. Rosebush is admitted to practice in the District of Columbia, Illinois, and Connecticut and before the U.S. Supreme Court and the U.S. Patent and Trademark Office.