Pharmacy and Pharmaceutical Law: Case Law Update

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.

Additionally, Lee is Leader of BakerHostetler's Pharmacy and Reimbursement team and Co-Leader of the FDA, Products Promotion, and Defense team.

Recognition

• Chambers USA: Recognized Practitioner: Healthcare: Pharmaceutical/Medical Products Regulatory in the District of Columbia (2016)
• American Society for Pharmacy Law: Larry M. Simonsmeier Writing Award (2016)
• Law360 "Rising Star" in Life Sciences (2015)
• Certificate of Appreciation by the FDA in recognition of outstanding contributions to the Office of Orphan Products Development (2004)

Memberships

• Food and Drug Law Institute (FDLI): Drugs Committee (2015 to 2018)
• Parenteral Drug Association: Member
• American Society for Pharmacy Law: Sponsorship Committee