Band 3
Provided by Lee H Rosebush
With a background as a defense, regulatory and registered patent attorney who has also worked as a registered pharmacist, Lee Rosebush provides his clients with legal counsel that is grounded in first-hand experience. Whether his clients are confronted with legal issues related to the naming of a drug, clinical trials, marketing, promotions or advertising, Lee possesses a strong understanding of the pharmaceutical industry which, combined with his attention to detail and experience working with biologics, medical device and healthcare companies, gives clients a single source for regulatory and litigation counsel.
With post-graduate degrees in finance and business, Lee is frequently sought out to help expedite corporate deals involving healthcare entities. He also advises private equity and public and private companies in due diligence matters and buy-sell transactions.
Lee's ability to smoothly shift between the legal, governmental, and pharmaceutical environments further helps him to efficiently secure operating licenses or assist drug manufacturers avoid compliance actions from governmental agencies. Active with the Drug Quality and Security Act (DQSA), as well as the Federal Food and Drug Administration's (FDA) regulation of pharmacy compounding, Lee speaks and writes on both issues, and is passionate about orchestrating and advocating for pharmacists and pharmacies. He was recently named an Affiliate Professor at the University of Maryland School of Pharmacy. Additionally, Lee is Leader of BakerHostetler's Pharmacy and Reimbursement team and Co-Leader of the FDA, Products Promotion, and Defense team.
National Association of Specialty Pharmacy (NASP) o
-- NASP Government Affairs committee (2023)
Food and Drug Law Institute (FDLI)
-- Curriculum Advisor
-- Drug Quality and Security Act Conference: Chair
-- Drugs Committee (2015 to 2018)
Outsourcing Facilities Association: Chairman
Parenteral Drug Association: Member
American Society for Pharmacy Law
-- Board of Directors
-- Sponsorship Committee (2016, 2017)
Provided by Chambers
Provided by Chambers
Lee handles even the most complex pharmacy regulatory issues with professionalism and agility. He is sharp, reliable and understands technical details, along with the anticipation of industry shifts.
Lee is straightforward and practical about his approach. He has strong relationships with the FDA, and so brings a level of knowledge that is hard to beat.
It is always a pleasure working with Lee. He is very professional in his approach at the same time, very transparent. He is very knowledgeable of regulatory law.
Lee handles even the most complex pharmacy regulatory issues with professionalism and agility. He is sharp, reliable and understands technical details, along with the anticipation of industry shifts.
Lee is straightforward and practical about his approach. He has strong relationships with the FDA, and so brings a level of knowledge that is hard to beat.
It is always a pleasure working with Lee. He is very professional in his approach at the same time, very transparent. He is very knowledgeable of regulatory law.