Laura E. Macherelli

Associate

Washington, D.C.
T +1.202.861.1603
F +1.202.861.1783

Overview

Laura Macherelli draws on her experience with the U.S. Food and Drug Administration as she helps clients navigate the ever-changing compliance requirements at the state, national and international levels. With a focus on pharmaceuticals, Laura advises clients on regulatory matters as well as compliance within product manufacturing and licensing.

In addition to the FDA, Laura also served in corporate compliance for a pharmaceutical company and and as a member of the medical affairs consulting team for a worldwide public relations firm.

Select Experience

  • Counseled multiple pharmaceutical firms on the government regulatory and approval process for products and marketing.
  • Conducted legal analysis of the electronic nicotine device landscape, and emerging products and companies, to determine FDA authorization and jurisdiction under the Food, Drug and Cosmetic Act and the Tobacco Control Act.
  • Assisted on drafting and developing federal regulations and guidance for the electronic nicotine device and tobacco industry.
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Experience

  • Counseled multiple pharmaceutical firms on the government regulatory and approval process for products and marketing.
  • Conducted legal analysis of the electronic nicotine device landscape, and emerging products and companies, to determine FDA authorization and jurisdiction under the Food, Drug and Cosmetic Act and the Tobacco Control Act.
  • Assisted on drafting and developing federal regulations and guidance for the electronic nicotine device and tobacco industry.
  • Advised pharmaceutical firms and healthcare providers on compliance with the False Claims Act, Anti-Kickback Statute, Stark Law, Federal Physician Payments Sunshine Act and related state laws, as well as the European Federation of Pharmaceutical Industries and Associations Disclosure Code.

Recognitions and Memberships

Memberships

  • District of Columbia Bar Association
  • National Italian American Bar Association

Prior Positions

  • U.S. Food and Drug Adminstration, Center for Tobacco Products: Regulatory Counsel 
  • Otsuka Pharmaceuticals: Corporate Compliance Fellow 
  • Ogilvy Public Relations Worldwide: Account Executive 

Admissions

  • District of Columbia

Education

  • J.D., University of Maryland Francis King Carey School of Law, Journal of Health Care Law and Policy, Senior Articles Editor; Health Care Law Certificate
  • M.P.H., George Washington University, Milken Institute School of Public Health
  • B.S., Health Sciences, University of Maryland

Languages

  • Italian

Blog

In The Blogs

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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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AD-ttorneys Law Blog
Advertising and Regulation of CBD Products
By Laura E. Macherelli, Lee H. Rosebush, Randal M. Shaheen
August 9, 2022
If you have been to any kind of spa, beauty supply store or health food store in the past four years, chances are you have seen, if not purchased, a product with cannabidiol (CBD). The 2018 passage of the Farm Bill removed hemp-deprived...
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