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, Dean's list, magna cum laude, 2010
Admissions
  • Georgia
  • Colorado
  • Washington

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. By knowing a client’s business and understanding their products, I am able to efficiently solve legal issues to advance a company's business goals."

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.

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.

Certificate of Appreciation and Commendation, State Bar of Georgia, For Work With Former Service Members and Their Families, 2015.

Co-author, "Dying While Waiting, A Right to Try or A Right to Die: FDA’s Regulatory Hurdles, Georgia Law, and Current Federal Legislation in Access to Experimental Drug," forthcoming 2018
Co-author, "Medical Device Basics," Glaucoma Research and Clinical Advances 2016 to 2018, 2016
Author, "What does Informed Consent have to do with Undercover Videos, Planned Parenthood and Congress?," Health Law Developments, The Newsletter of the Health Law Section, State Bar of Georgia, Spring 2016
"From Patient to FDA: Insights Into Thinking About KOL Engagement, FDA Approvals & Ultimately, The Market," DKBIO2018 Danish Science & The City Edition, April 10 & 11, 2018
Panelist, "Retail, Specialty, Compounding and Other Pharmacy Investment Opportunities," 15th Annual Healthcare and Life Sciences Private Equity and Finance Conference, February 21, 2018
5 Key Takeaways on Top Surgical Specialty Investments, The Healthcare Investor, March 19, 2018