Royce B. DuBiner Associate

Royce advises pharmaceutical, medical device, dietary supplement, food and beverage companies as well as private equity firms on a range of regulatory matters. He has experience handling complex issues arising with industries regulated by the United States Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), Tobacco Tax and Trade Bureau (TTB), United States Centers for Medicare and Medicaid (CMS), United States Department of Agriculture (USDA), and the Federal Trade Commission (FTC).

He has worked with businesses on controlled substance scheduling and theft, drug diversion, criminal violations of the Food Drug and Cosmetics Act (FDCA), FDA audits, product labeling and promotion, product recalls, government pricing, drug wholesale, food distribution, product promotion, product claims, current good manufacturing practices (cGMPs), PhRMA and AdvaMed Code. Royce also advises both buyers and sellers on the regulatory risks of healthcare, food, and life sciences transactions. Additionally Royce works to solve problems at the State level with Boards of Pharmacy and State regulation of Hemp and Hemp extract containing products.

Prior to joining McGuireWoods, Royce worked for an Institutional Review Board (IRB) and served as the Associate Counsel for Regulatory Affairs at a drug, medical device, and dietary supplement company. In this position, he oversaw all regulatory aspects from manufacture to marketing of the company’s products, including overseeing four successful branded pharmaceutical product launches. Royce presently advises on a range of issues including;

  • FDA regulation, enforcement, inspections, and due diligence of companies;
  • USDA inspections, regulations, and due diligence of companies;
  • Human Subject Protection and Clinical Drug Trials;
  • Medical device manufacturing and post-market safety;
  • Drug and pharmaceutical product marketing, labels, pharmacovigilance, adverse events, and labeling;
  • Food safety, labeling, and manufacturing issues;
  • Food Safety Modernization Act (FSMA);
  • Comprehensive Laboratory Improvement Act (CLIA) accreditations and licensure of laboratories;
  • Physician dispensing, physician disciplinary issues, drug theft, and off-label drug use;
  • Human and Veterinary Compounding Pharmacies, 503A and 503B outsourcing facilities;
  • Human tissue banking and tissue sales;
  • Software as a medical device;
  • Alcohol labeling and manufacture;
  • Wholesale generic drug sales;
  • State regulation of telemedicine and electronic drug prescribing laws;
  • Promotional review committee for drug product labels and labeling;
  • State Boards of Pharmacy and manufacturing and wholesale licensure;
  • Physician Payments Sunshine Act;
  • Prescription Drug Marketing Act (PDMA);
  • Trade Adjustment Assistance to Trade Agreements Act of 1979 (TAA);
  • Federal Anti-Kickback;
  • Quality agreements with contract manufacturers and laboratories;

His past in-house experience gives him insight into the complex mechanics and challenges healthcare and life sciences companies face in growth, compliance, supply, marketing, and manufacturing. He blends legal strategy with business sense to construct practical solutions that match the needs of clients in these heavily regulated industries.

In addition to his current practice, Royce handles pro bono cases for veterans in order to seek benefits for injuries sustained in service and correct service records.

"My time spent in industry gives me a business minded approach to law and my clients. By knowing the client’s business and caring about their products I am able to solve legal issues to advance the business solution."

Experience

Advised on over four successful product launches of both drug and dietary supplement products.

Advised on numerous product recalls and safety issues with foods, drugs, and medical devices.

Drafted human subject protection policies and procedures for academic institutions;

Managed USDA and FDA diligence for the successful acquisition of a national manufacturer of snack products.

Assisted in state and local food safety compliance diligence for the successful acquisition of a national restaurant chain.

Designed compliance programs for emerging plant based food products.

Drafted policies and procedures for medical device, food, beverage, and pharmaceutical companies.

Advised multiple publicly traded life sciences companies and private equity funds in mergers and acquisitions, conducting comprehensive due diligence to spot and correct problems.

Lead the legal review for the joint-development of a biosimilar.

Advised on hemp and hemp extract products at the state and federal levels.

Assisted in the defense of criminal violations of the Food, Drug, and Cosmetics Act.

Provided guidance and resolved issues arising with suspected carcinogenic chemicals in human food.

Solved state licensure issues for manufacturers and wholesalers of drug products before state board of pharmacy.

Trained pharmaceutical sales representatives on current law as it relates to the promotion of drug products.

Aided defense team as regulatory counsel on a drug product liability claim involving birth-defect.

Effected change at the local level and in public meetings advocating for policies to advance the ability to market pharmaceutical products.

Advised on prescription and over the counter drug and dietary supplement labels, labeling, and promotion as the legal representative for the promotional review committee of a pharmaceutical company, overseeing all promotional materials and product labeling.

Regulatory counsel on five separate Lanham Act cases involving false claims for drug and supplement products.

Negotiated pharmaceutical wholesale drug sale agreements and purchase agreements for raw materials enabling sales team to $200 million dollar sales targets.

Created a comprehensive product legal and regulatory database for company for current products and labeling.

  • Emory University School of Law, LLM, 2015
  • University of Denver Sturm College of Law, JD, 2013
  • Goucher College, BA, History, magna cum laude, 2010
  • Georgia
  • Colorado
  • District of Columbia
  • Illinois
  • Washington
  • U.S. Court of Appeals for Veterans Claims
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