Marc N. Wagner

Associate

Washington, D.C.
T +1.202.861.1557
F +1.202.861.1783

Overview

Marc Wagner focuses his practice on regulatory and transactional matters, primarily in the healthcare and life sciences industries. He has experience advising clients on Food and Drug Administration (FDA) regulatory matters, including food, drug, device, dietary supplement and cosmetic issues, as well as matters related to compounding pharmacies operating pursuant to Section 503A of the Federal Food, Drug and Cosmetic Act (FD&C Act) and outsourcing facilities operating pursuant to Section 503B of the FD&C Act.

Marc also has experience assisting clients with matters related to Drug Enforcement Administration (DEA) compliance. In addition, he helps drug manufacturer, pharmacy, wholesaler and third-party logistics provider clients navigate state licensing, pharmacy practice and drug control act issues.

Marc’s educational and professional background as a registered pharmacist provides him with a substantial understanding of a variety of pharmaceutical compliance measures. This background enables him to assist with life science transactions and navigate federal and state licensing for human and veterinary drug manufacturers, wholesale distributors, pharmacies and outsourcing facilities.

Select Experience

  • Counseled multiple pharmaceutical firms in sale of stock to private equity groups.
  • Advised private equity group in acquisition of specialty pharmacy.
  • Provide ongoing counsel to national pharmacy transitioning state regulatory licenses and permits due to change of ownership.
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Experience

  • Counseled multiple pharmaceutical firms in sale of stock to private equity groups.
  • Advised private equity group in acquisition of specialty pharmacy.
  • Provide ongoing counsel to national pharmacy transitioning state regulatory licenses and permits due to change of ownership.
  • Advise firms in registering and complying with the DEA.
  • Advise firms in response to FDA inspections, Form 483s and recalls.
  • Counsel pharmaceutical firms on Current Good Manufacturing Practices (CGMPs).
  • Advised pharmaceutical firm under FDA and DOJ investigation.
  • Advised firm in exporting biological product.
  • Assisted chemical firm in acquisition of active pharmaceutical ingredient (API) manufacturer.
  • Represent pharmacies in front of state boards of pharmacy.
  • Provide counseling on drug pricing.
  • Counseled firms seeking Emergency Use Authorizations (EUA) during the COVID-19 pandemic.
  • Advised hospital on COVID-19 vaccination provider obligations and the Public Readiness and Emergency Preparedness Act (PREP Act).
  • Develops comments to FDA for industry trade associations and individual companies on FDA regulatory topics.
  • Develop citizen petitions to the FDA.

Recognitions and Memberships

Recognitions

  • JD Supra 2021 Readers Choice Awards, Life Sciences

Memberships

  • American Society for Pharmacy Law
  • Food and Drug Law Institute
    • Publications Peer Review Committee
    • New to Food and Drug Law (NFDL) Planning Committee (former)

Community

  • Catholic Charities Legal Network

Prior Positions

  • Drug Enforcement Administration, Office of Chief Counsel, Diversion and Regulatory Policy Section: Intern
  • Food and Drug Administration, Office of Policy: Intern
  • BakerHostetler: Summer Associate
  • Pharmacist in national retail pharmacy setting

Admissions

  • Pennsylvania
  • District of Columbia

Education

  • J.D., The Pennsylvania State University - Dickinson Law, Dickinson Law Review Articles Editor; CALI Award, Health Care Law & Policy, Health Care Innovation & Entrepreneurship
  • Certificate in Corporate Compliance with a Concentration in Health Care, The Pennsylvania State University - Dickinson Law
  • M.B.A., The Pennsylvania State University
  • Pharm.D., University of the Sciences, Philadelphia College of Pharmacy, cum laude
  • B.S., Pharmaceutical and Healthcare Studies, University of the Sciences, Philadelphia College of Pharmacy, cum laude