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 drug scheduling, controlled substances, FDA audits, importation issues, product promotion, product liability issues, labeling, government pricing, wholesale drug sales, ingredient acquisition, current good manufacturing practices (cGMPs), PhRMA and AdvaMed Code. Royce also advises both buyers and sellers on the regulatory risks of healthcare and life sciences transactions.

Prior to joining McGuireWoods, Royce has worked for an Institutional Review Board and has 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. In-house, Royce advised on:

  • FDA regulation and enforcement, 483 responses
  • Human Subject Protection and Clinical Trials
  • Abuse-deterrent opioid based pain medications
  • Combination drug and device products for intravenous drug administration
  • Wholesale generic drug sales
  • Pharmacovigilance and adverse event reporting
  • Promotional review committee for product labels and labeling
  • State boards of pharmacy and licensure
  • Physician Payments Sunshine Act
  • Prescription Drug Marketing Act
  • Trade Adjustment Assistance to Trade Agreements Act of 1979 (TAA)
  • Federal Anti-Kickback
  • Quality agreements with contract manufacturers and laboratories
  • Regulatory due diligence for mergers, acquisitions, and sales

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 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.

Part of deal team representing employer in regulatory due diligence two separate transactions each valued over $50 million dollars.

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 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 three 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
  • Moderator, "FDA Update: Recent Developments and New Initiatives," 10th Annual Pharmaceutical and Medical Device Conference, November 15, 2018
  • Panelist, "Retail, Specialty, Compounding and Other Pharmacy Investment Opportunities," 15th Annual Healthcare and Life Sciences and Private Equity and Finance Conference, February 21, 2018
  • Georgia
  • Colorado
  • District of Columbia
  • Illinois
  • Washington
  • U.S. Court of Appeals for Veterans Claims
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