Royce B. DuBiner

Associate

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

Royce is a member of the firm’s healthcare practice focusing on challenging healthcare transactional and regulatory matters. He advises clients in the life sciences industry on regulatory policy and guidance, drug scheduling, drug enforcement, human subject protection, government pricing, sole-source drugs, biologics, medical foods, dietary supplements, combination drug and device products, convenience kits, drug and device promotion, technology transfer, drug database product linkage, FDA audits, importation, drug product listings, state pharmacy boards, drug and ingredient supply agreements, wholesale drug sales, group purchasing agreements for drugs, contract manufacturing, drug serialization, current good manufacturing practices (cGMPs), new dietary ingredients, drug diversion, pharmaceutical and device industry employment agreements, PhRMA Code, product co-promotion, regulatory due diligence for mergers or acquisitions, and general corporate matters for the life sciences industry.

Royce’s experience touches upon most aspects of the pharmaceutical industry. Prior to joining McGuireWoods, Royce worked for an Institutional Review Board and 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. Specifically in-house he advised on;

  • Drug Supply Chain Security Act
  • State boards of pharmacy and licensure
  • Promotional review committee for product labels and labeling
  • Regulatory due diligence for debt refinance, mergers, and acquisitions
  • Government pricing for Veterans Affairs and Centers for Medicaid and Medicaid
  • Trade Adjustment Assistance to Trade Agreements Act of 1979 (TAA)
  • Sales representative training and industry ethics
  • Federal Anti-Kickback Statute
  • Employment issues arising with pharmaceutical executives an in-field sales representatives
  • Quality agreements with contract manufacturers and laboratories
  • Theft of trade secrets for the development of pharmaceutical products
  • Drug and Device Product classification
  • Prescription to Over the Counter (OTC) product conversion
  • Drug database product linkage
  • Pharmaceutical product defects
  • Drug diversion and pedigree requirements for wholesalers of drug products
  • FDA audits involving 483s and agency inquiries
  • Contract manufacturing agreements for the development of drugs and supplements
  • Adverse event reporting and pharmaceutical product recalls
  • Physician Payments Sunshine Act
  • Prescription Drug Marketing Act
  • Drug diversions and unlawful sales of pharmaceutical products
  • Drug recycling programs at the municipal and county level
  • FDA regulation and enforcement, 483 responces
  • Abuse-deterrent opioid based pain medications
  • Combination drug and device products for intravenous drug administration
  • PhRMA Code
  • Pharmacovigilance and adverse event reporting
  • Drug rebate programs
  • Wholesale generic drug sales

Royce is a boots on the ground attorney with a unique ability to spot issues and solve regulatory challenges before they become problems. He goes to great lengths to understand all aspects of his client’s business and their products as though they were his own. He has also authored a chapter in a medical textbook on medical devices.

"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."

Royce DuBiner
vCard
T: +1 404 443 5710F: +1 404 443 5679Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534

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

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

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

Advised on prescription & 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.

Defended company and designed legal strategy in multiple employment issues arising under in-filed sales representatives involving non-competition agreements and alleged EEOC claims.

Negotiated pharmaceutical wholesale drug sale agreements and purchase agreements for raw materials enabling sales team to $100 million dollar sales targets.

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

Co-author, Medical Device Basics, Glaucoma Research and Clinical Advances 2016 to 2018, 2016
5 Key Takeaways on Top Surgical Specialty Investments, The Healthcare Investor, March 19, 2018