Lee H. Rosebush

Partner

Washington, D.C.
T +1.202.861.1567
F +1.202.861.1783

"Lee is knowledgeable of industry regulations and follows emerging trends. He knows our business inside and out and is able to assess potential hurdles with ease."

— Chambers USA 2022

Overview

A defense, regulatory and registered patent attorney with experience as a registered pharmacist, Lee Rosebush counsels companies and executives as a strategic business advisor and serves as outside general counsel for pharmaceutical and pharmacy industry clients. His in-depth industry knowledge and experience working with biologics, medical device and healthcare companies gives clients a single source for regulatory, diligence and litigation counsel. Clients reach out to Lee as the first point of contact when confronted with legal issues related to development, operations, investment, marketing, advertising or product promotion.

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.

Select Experience

  • Lee represented a mail order pharmacy in its sale of stock to a pair of private equity groups.
  • Lee represented a residential treatment center in an administrative Formal Hearing involving an alleged $1.1 million Medicaid overpayment and obtained an outcome in favor of his client.
  • Lee represents a multinational food manufacturer and caterer in matters involving the FDA and USDA.

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Experience

  • Lee represented a mail order pharmacy in its sale of stock to a pair of private equity groups.
  • Lee represented a residential treatment center in an administrative Formal Hearing involving an alleged $1.1 million Medicaid overpayment and obtained an outcome in favor of his client.
  • Lee represents a multinational food manufacturer and caterer in matters involving the FDA and USDA.
  • Lee advised private equity groups specializing in the healthcare industry in a stock purchase of worker compensation specialty pharmacy.
  • Lee represented a mail order pharmacy during a DEA and State Board of Pharmacy investigation into the company's controlled substance dispensing and record keeping practices.
  • Lee provides ongoing counseling to a large national multifacility healthcare system on the system's 340B practices.
  • Lee assisted several entities with establishing a compounding entity and registering it with the FDA as a 503B Outsourcing Facility.
  • Lee represented a large mail order pharmacy in its negotiations with DEA involving DEA's constructive delivery/transfer national policy position.
  • Lee provides ongoing counseling to a large national health plan on strategic initiatives.
  • Lee advised both drug manufacturers and healthcare entities on FDA's regulation of the importation of prescription drugs.
  • Lee represented a Medicare Part D Plan in its acquisition of a PBM and several resulting regulatory matters.
  • Lee provides ongoing counseling to a car manufacturer in its review of the manufacturer's advertising policies in light of FTC regulation.
  • Lee advised a dietary supplement distributor during its review of the company's advertising SOPs.
  • Lee worked with a multinational food manufacturer in reviewing HACCP plans and environmental monitoring programs.
  • Lee worked with a food manufacturer in addressing environmental findings of listeria and their response plan to work with multiple governmental agencies.
  • Lee has negotiated multiple supply and quality agreements on behalf of food manufacturers and national caterers.
  • Lee has conducted multiple mock inspections to prepare food manufacturing and catering facilities.

Recognitions and Memberships

Recognitions

  • Chambers USA: Healthcare: Pharmaceutical/Medical Products Regulatory in the District of Columbia (2018, 2021 to 2023)
    • Band 3 (2021 to 2023)
    • Up & Coming (2017 to 2018), Recognized Practitioner (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

  • 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)

News

News

Press Releases

Prior Positions

  • Associate in the healthcare group of a national law firm.
  • Pharmacist in hospital and national retail pharmacy settings in Indiana and Ohio.
  • Gained regulatory experience during time at a FORTUNE 500 drug company.
  • U.S. Food and Drug Administration: Office of Orphan Products.

Admissions

  • U.S. Supreme Court
  • U.S. Patent and Trademark Office, Registration No. 64,414
  • District of Columbia
  • Illinois
  • Connecticut

Education

  • J.D., Case Western Reserve University School of Law
  • Pharm.D., Purdue University
  • M.S., Indiana University, Finance
  • M.B.A., Indiana University

Blog

In The Blogs

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Health Law Update
Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products
By Winston S. Kirton, Lee H. Rosebush, Lynn Sessions
May 15, 2023
On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between FDA’s Center for...
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Health Law Update
Cybersecurity in Medical Devices
By Laura E. Macherelli, Lee H. Rosebush, Lynn Sessions
April 10, 2023
The U.S. Food and Drug Administration (FDA) has issued new guidance to the medical device industry on the importance of cybersecurity measures in product development. The nonbinding guidance, titled “Cybersecurity in Medical Devices...
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Health Law Update
Staying Ahead of the Curve in Biopharma: Navigating FDA Inspections, Drug Supply Chain Security Act (DSCSA) Implementation, and Supply Chain Disruptions
By Winston S. Kirton, Lee H. Rosebush
April 6, 2023
FDA inspections of biopharmaceutical manufacturers often lead to the discovery of avoidable compliance issues. On today’s episode, Staying Ahead of the Curve in BioPharma: Navigating FDA Inspections, Drug Supply Chain Security Act (DSCSA)...
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Health Law Update
FDA Issues Guidance on Clinical Research with Cannabis
By Winston S. Kirton, Laura E. Macherelli, Lee H. Rosebush, Randal M. Shaheen
January 27, 2023
On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. The...
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Health Law Update
Allergan Win in Medicaid Drug Rebate Statute
By Laura E. Macherelli, Lee H. Rosebush, Stephen E. Ruscus
October 21, 2022
The United States Court of Appeals for the Fourth Circuit decision in US ex rel. Sheldon v. Allergan Sales, LLC, a qui tam False Claims Act (FCA) suit, affirms the complexity of pricing and Medicaid rebates under the Medicaid Drug Rebate...
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