Areta Kupchyk

Partner, Co-Chair, Administrative Law Department and FDA Practice - Washington, D.C.

Areta Kupchyk
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Contact Information

202.261.7324

202.785.6687

akupchyk@foleyhoag.com Download vCard

Areta Kupchyk is an FDA lawyer who advises biotechnology, medical device, and pharmaceutical companies, as well as health care providers and institutions, researchers, and investors, on FDA-related matters. Areta draws upon 30 + years of experience as an FDA lawyer, including nearly 10 years at the FDA where she served as Associate Chief Counsel for Drugs and Biologics and Assistant General Counsel for Litigation, to provide clients with nuanced counsel on FDA’s pre- and post-approval requirements.

Clients rely on Areta's counsel to identify the most expedient regulatory pathways to get products to market and to obtain all possible benefits, such as market exclusivities. For example, Areta has helped clients advance breakthrough therapies, including cellular and gene therapies and other personalized medicine products, in vitro diagnostics and laboratory developed tests, or LDTs, and genetic and digital therapeutic devices. In addition, Areta counsels extensively on FDA’s regulation of human cell, tissue, and cellular and tissue-based products, or HCT/Ps, including current Good Tissue Practice (cGTP), Donor Eligibility, and communications with the Tissue Reference Group (TRG), as well as Requests for Designation (RFDs) from the Office of Combination Products. 

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Education:

  • University of Maryland School of Law, J.D., Order of the Coif, Dean’s Elizabeth Maxwell Carroll Chesnut Prize for good scholarship
  • University of Maryland Baltimore County, B.A.

Representative Experience

  • Counseled a national humanitarian non-profit organization in the divestiture of its human tissue procurement service, at that time the largest tissue service in the country, resulting in a $22 million deal. Ensured regulatory compliance with FDA regulations for product registration and listing, labeling, advertising, Good Manufacturing Practices (“GMPs”), and Good Tissue Practices (“GTPs”).
  • Assisted medical device companies in navigating FDA regulatory requirements and policies for medical mobile applications and Health IT Software for clinical support.
  • Assisted a pharmaceutical company in developing a strategy to work with FDA as they negotiated approval issues for their first product and evaluated launch materials for compliance with FDA’s advertising and marketing policies.
  • Counseled one of the world’s largest pharmaceutical manufacturers on potential fraud in the manufacturing process of one of its products and successfully negotiated with the FDA to avoid invocation of the Application Integrity Policy (“AIP”). Also provided extensive cGMP documentation training to affected company employees.
  • Advised a biopharmaceutical company on issues related to its first product launch, including the review of SEC filings and promotional materials.
  • Assisted a pharmaceutical manufacturer with its negotiation of the FDA application process, and obtaining approval of one of its products as a “hybrid generic.”
  • Reviewed the promotional materials of a specialty pharmaceutical company that manufactures dermatology products. Prepared an FDA expert for an arbitration hearing. Assisted the company in developing a strategy to obtain approval to co-package products.
  • Assisted a major medical device manufacturer with a comprehensive review and overhaul of its SOPs related to recalls and risk management. Reviewed for legal sufficiency all interrelated SOPs, including those that deal with pre-approval, design, post-approval, field monitoring, health hazard events and reporting, and corrective action plans. Also provided product liability risk training to staff on proper documentation practices related to adverse event reporting and complaint handling.
  • Counseled a start-up company developing a new treatment for prostate cancer, including regulatory review of licensing agreements and clinical trial agreements, a cost-recovery request to FDA during clinical trials, and review of launch materials, as well as marketing outside the United States.
  • “Amarin and Off-Label Promotion: What's Next? —Two attorneys discuss the implications of FDA's settlement,” MedPage Today, March 28, 2016 (co-author with Michele Adelman)
  • “Approval of Biotechnology Products for Human Use” and “Federal and State Regulation after Approval,” Medical Biotechnology: Premarket and Postmarket Regulation, 2015 ed., American Bar Association
  • “FDA’s ‘Same Surgical Procedure’ Draft Guidance Could Stifle Use of Autologous Stem Cell Therapies,” AHLA Executive Summary, June 11, 2015
  • “FDA’s Authority to Regulate Pharmacy Compounding: Who’s Responsible?” Corporate Compliance Insights, January 16, 2013
  • “Handling an FDA inspection: Dos, Don’ts and When to Call a Lawyer,” Corporate Compliance Insights, August 20, 2012
  • “Achieving Quality and Compliance Excellence in Pharmaceuticals” – A Master Class GMP Guide, First Edition 2012 (co-author)
  • “Drug, Device, and Biotechnology Manufacturing Requirements,” Corporate Compliance Insights, July 2, 2012
  • “Off-Label Communications: The FDA's Proposed Approach Product Liability,” Law & Strategy, July 1, 2012
  • “Comment: FDA's Draft Guidance on Social Media and Off-Label Communications,” Bloomberg BNA Social Media Law & Policy Report, June 19, 2012
  • “The Park Doctrine and AIP: Two Little-Known But Powerful FDA Enforcement Tools,” Corporate Compliance Insights, April 17, 2012
  • “FDA’s Draft Guidance on Social Media and Off-Label Communications,” Bloomberg BNA, January 25, 2012
  • “Will Your Products Be Subject to the New 2.3% Federal Excise Tax on "taxable medical devices" Next Year?”, Tax Alert, May 23, 2012 (co-author)
  • “FDA Issues Biosimilar Draft Guidance,” FDA Alert, February 28, 2012 (co-author)
  • “FDA's Draft Guidance on Social Media and Off-label Communications,” FDA Alert, January 26, 2012
  • “Network Interference: A Legal Guide to the Commercial Risks and Rewards of the Social Media Phenomenon,” FDA Chapter, Food and Drug Law Institute, 2010 (co-author)
  • “Coming Soon! FDA’s Current Thinking on Social Media and Product Promotion,” Corporate Compliance Insights, June 2010. (co-author)

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Honors

  • Recognized by LMG Life Sciences since 2012 as a “Life Sciences Star”
  • Listed in The Best Lawyers in America in the fields of Biotechnology and Life Sciences Practice and FDA Law (2008-2022)
  • Three-time recipient of the FDA Commissioner’s Special Citation for Outstanding Achievement, including special recognition for her role in developing a regulatory framework for human cellular and tissue-based products, and the FDA guidance on pharmaceuticals produced with bioengineered plants.

Involvement

  • FDA Alumni Association, member
  • Food and Drug Law Institute, member
  • Maryland State Bar Association, member
  • American Bar Association, member
  • Panelist, “How are Manufacturers Handling CBD Labeling and Marketing Issues,” Legal and Practical Issues in the Evolving World of Cannabis Regulation Conference, FDLI  (November 2019)
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Bar Admissions

  • Maryland
  • District of Columbia

Court Admissions

  • U.S. District Court for the District of Maryland