Royce B. DuBiner Associate

Royce advises pharmaceutical, medical device, cannabis, dietary supplement, tobacco, 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 United States Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), Alcohol and Tobacco Tax and Trade Bureau (TTB), United States Centers for Medicare and Medicaid (CMS), United States Department of Agriculture (USDA), Environmental Protection Agency (EPA), and the Federal Trade Commission (FTC), state and federal regulation of cannabis and drug analogues.

He has worked with businesses on complex issues regarding drug and food labeling, scheduling of controlled substances, product recalls, food contamination, theft of controlled substances, importation of drugs and medical devices, criminal violations of the Food Drug and Cosmetics Act (FDCA) including Park Doctrine considerations. Additionally, Royce has assisted on FDA Audits, unannounced inspections, product promotion issues, drug pricing, and current good manufacturing practices (cGMPs), Good Clinical Practices (GCP),  mobile applications, Group Purchasing Organizations (GPO), controlled substances and Telemedicine, 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 with banking and product compliance for direct and indirect Cannabis related industries including CBD, Hemp, and Marijuana product.

Prior to joining McGuireWoods, Royce served as an extern at INTERPOL, the United States Environmental Protection Agency (EPA) Office of Enforcement and Compliance Assurance (OECA), 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;
  • Premarket Tobacco Product Applications (PMTA) and Electronic Nicotine Delivery Systems (ENDS);
  • USDA inspections, regulations, and due diligence of companies;
  • Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) guidance;
  • Alcohol labeling and taxation compliance;
  • Compliance with the Federal Analogue Act
  • 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, home testing, and licensure of laboratories;
  • Drug treatment and Substance Abuse and Mental Health Services Administration (SAMHSA);
  • Physician dispensing, physician disciplinary issues, drug theft, and off-label drug use;
  • Human and veterinary compounding pharmacies, 503A and 503B outsourcing facilities;
  • FDA Food Contact Surfaces and EPA regulated insecticides;
  • Human tissue banking and tissue sales;
  • Software as a medical device;
  • Cannabis banking and compliance;
  • Wholesale generic drug sales;
  • Advise on securities filings for Securities and Exchange Commissions (SEC) regulated publically traded life sciences companies;
  • 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

Representation of  B. Riley FBR, Inc. (formerly FBR Capital Markets & Co.) as placement agent in connection with the extension of its existing relationship with Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company.

Representation of Alliance Global Partners (AGP), a regional investment and advisory firm providing investment advisory and brokerage services to individuals and institutions, in connection with the launch of an at-the-market program in which AGP serves as placement agent to ProPhase Labs, Inc. (Nasdaq: PRPH), a manufacturing and marketing company with experience with OTC consumer healthcare products and dietary supplements.  

Representation of National Securities Corp., acting as exclusive placement agent, in connection with a private offering and sale of preferred stock by Cyprium Therapeutics, Inc., a clinical-stage biopharmaceutical company.

Advised multiple banks on requirements and federal law for banking Marijuana and Hemp businesses.

Aided in the drafting and review of Premarket Tobacco Application (PMTA) for a novel nicotine product for modified risk use tobacco product.

Organized document review and designed policies for large scale advocacy project for redaction of confidential client information within FDA applications under Freedom of Information Act (FOIA) exemptions.

Filed and aided on issues of FOIA in litigation.

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 national restaurant chains.

Designed compliance programs for emerging plant based food products for a major international manufacturer.

Added in the security filing review for multiple publicly traded companies with regards to their statements involving drug efficacy, clinical trials, and competition.

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

Served as regulatory counsel on class action food product liability litigation involving allegations of consumer fraud.

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.

Advised food and beverage companies for the manufacture of Over The Counter (OTC) hand sanitizer during the COVID-19 Emergency.

.Added in importation of medical devices, masks, and drugs during the COVID-19 Emergency and associated issues with United States Customs and Border Protection (CBP).

Registered and listed multiple companies and their products on FDA CDER Direct and FURLS.

Assisted as regulatory counsel 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.

Represented companies before FDA on issues of drug recall, importation, and product compliance.

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 dietary 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

Member, Editorial Advisory Board, FDLI Update, Food and Drug Law Institute, 2020-present

  • Georgia
  • Colorado
  • District of Columbia
  • Illinois
  • Washington
  • U.S. Court of Appeals for Veterans Claims
  • U.S. District Court for the Eastern District of Washington

Named a "Cannabis Law Trailblazer", The National Law Journal, 2020

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