Winston S. Kirton

Partner

Washington, D.C.
T +1.202.861.1715
F +1.202.861.1783

Overview

Winston Kirton advises both domestic and international companies that are facing regulatory challenges involving products and services regulated by the FDA, including biopharmaceutical, medical device, food and dietary supplements, in connection with corporate transactions, research and development, manufacturing and supply chain, and commercial regulatory and compliance matters. He also advises clients regarding legal disputes related to third-party contract manufacturing relationships, third-party supplier relationships and alliance-partner relationships.

Due to his significant experience with the complex FDA requirements, Winston is able to guide clients and their most significant deals through all aspects of FDA regulatory due diligence. He provides comprehensive advice to clients facing legal and regulatory challenges with products and services regulated by the FDA, including on how to address the FDA regulatory process. 

Winston accumulated in-depth international legal and business life sciences experience through a variety of in-house positions at several large multinational biopharmaceutical companies, particularly in the areas of quality and compliance, regulatory affairs, compliance and ethics and legal affairs. This allows him to provide clients with a holistic view of their regulatory matters when combined with his knowledge of the regulatory process for pharmaceuticals, medical devices, foods and dietary supplements.

Winston previously served as the head of compliance and ethics, while based in London, for a multinational U.S. pharmaceutical company, and was responsible for business units comprised of Latin America, Central and Eastern Europe, Middle East-Asia-India, China and the Pacific Rim regions.

Select Experience

  • Represented several private equity clients on acquisitions and sale of FDA regulated food, medical devices, biopharmaceuticals and dietary supplement products.
  • Represented pharmaceutical client on its acquisition of diabetes medical device asset.
  • Represented Danish pharmaceutical client on collaboration negotiations with U.S. medical device partner.
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Experience

  • Represented several private equity clients on acquisitions and sale of FDA regulated food, medical devices, biopharmaceuticals and dietary supplement products.
  • Represented pharmaceutical client on its acquisition of diabetes medical device asset.
  • Represented Danish pharmaceutical client on collaboration negotiations with U.S. medical device partner.
  • Conducted end-to-end compliance risk assessment of clients’ corporate operations in response to derivative suit settlement agreement.
  • Represented client in response to state compliance stop-use order for hand sanitizer distribution and sale.
  • Advised retail client on its strategy for introducing CBD products in stores nationally.
  • Advised client on regulatory strategy for introduction of foreign plant-based foods to U.S. market. 
  • Advised client on compliance requirements for labeling and marketing dietary supplement products for mothers.
  • Advised and counseled UK client on FDA Investigational New Drug Application (IND) submission strategy for switching a non-U.S. dietary supplement product to a U.S. approved pharmaceutical.
  • Conducted risk assessment and advised client on its non-U.S. employee vaccination strategy.
  • Represented client in response to DOJ civil investigative demand and deposition.
  • Developed client’s enterprise-wide corporate compliance risk survey.
  • Helped client redesign its corporate compliance program including the development of sales force healthcare professionals (HCP) interactions policy.
  • Helped client develop Emergency Use Authorization (EUA) strategy for COVID-19 medical product introduction.
  • Assessed and redesigned client’s Code of Ethics and delivered employee training.
  • Helped client renegotiate its medical device supply agreement with key third-party alliance partner.
  • Conducted risk assessment of client’s third-party screening strategy and helped client redesign program.

Recognitions and Memberships

Recognitions

  • The Legal 500 United States
    • Key Lawyer in Healthcare: Life Sciences and Healthcare: Service Providers (2021)
    • Key Lawyer in Dispute Resolution: Corporate Investigations and White Collar Criminal Defense (2021 to 2022)

Memberships

  • Law360 Life Sciences Editorial Advisory Board (2021)
  • CPR Healthcare and Life Sciences Committee: Mitigating Risk in Life Sciences Transactions Task Force
  • Food and Drug Law Institute: Enforcement, Litigation, and Compliance Conference Planning Committee (2021 to 2022)

Community

  • First Baptist Church of Lincoln Gardens, NJ: Trustee
  • International Senior Lawyers Project: Volunteer Attorney
  • Women of Color in Pharma: Advisory Council

Admissions

  • New Jersey
  • District of Columbia

Education

  • M.M.B.A., Biopharma Innovation, Rutgers University, 2014
  • J.D., Seton Hall University School of Law, 2003
  • B.S., Biology, Niagara University, 1987