Kupchyk

Areta Kupchyk

Partner
Co-Chair, Administrative Law Department and FDA Practice
Washington, DC

I help FDA regulated companies balance regulatory compliance requirements with their unique business interest

As Co-Chair of Foley Hoag's FDA Practice Group, Areta advises biotechnology, medical device, and pharmaceutical companies, as well as health care providers and institutions, researchers, and investors on matters related to the U.S. Food and Drug Administration (FDA).

Areta draws on over 30 years of experience, including nearly 10 years at the FDA where she served as Associate Chief Counsel, to advise clients on regulatory compliance, product development, and marketing opportunities. She provides clients with nuanced advice on FDA’s IND and IDE preapproval requirements for clinical studies of investigational drug and device products as well as FDA post-approval requirements, including advertising and promotion restrictions, adverse event vigilance, Medical Device Reporting, and current Good Manufacturing Practice (cGMP) regulations.

Getting to Marketing Approval
Clients rely on Areta's counsel to identify expedient regulatory pathways to move products to market, including 505(b)(2) applications, biosimilars, De Novo Classifications, and Emergency Use Authorizations, as well as the traditional NDA, BLA, 510(k) and PMA pathways. During product development and premarket review, Areta helps clients pursue all possible regulatory advantages, such as market exclusivities, orphan and breakthrough therapy designations, exemptions, priority reviews, and vouchers. For example, Areta has helped clients advance novel products such as cellular and gene-therapies, biologics, in vitro diagnostics (IVDs), pharmacogenomic tests, digital therapeutics and other software as a medical device (SaMD). In addition, Areta counsels extensively on FDA’s regulation of human cell, tissue, and cellular and tissue-based products (HCT/Ps), including current Good Tissue Practice (cGTP), and donor eligibility, and assists clients prepare submissions to the Tissue Reference Group (TRG) and Requests for Designation (RFDs) to the Office of Combination Products (OCP).

Balancing Business with Regulatory Compliance
Areta has significant experience helping clients manage the tension between business imperatives and regulatory responsibilities, ensuring sound reasoning and documentation. When noncompliance is an issue, Areta assists clients develop timely and consequential responses to 483s, Untitled and Warning Letters, and other FDA inquiries. Areta also has keen experience analyzing whether recalls are necessary, facilitating needed recalls, and navigating FDA interactions. Whether a matter involves internal assessments or government investigations, Areta provides pragmatic counsel to help clients maintain the right regulatory footing.

Protecting Integrity of Clinical Trials
When medical product manufacturers, clinical researchers, and research institutions face questions about the integrity of data, Areta uses her experience to help prevent the invocation of the Application Integrity Policy, or AIP. Among other things, Areta assists clients in conducting internal investigations into suspected wrongful conduct and implementing corrective actions.

Maximizing Advertising and Promotional Activities
Areta's practice also includes the FDA regulation of advertising and promotional activities for regulated products, including biopharmaceuticals and biotechnology products, cannabis and CBD products, dietary supplements, and cosmetics. 

Keeping the Business Running
Working closely with the firm’s business lawyers, Areta advises clients on FDA issues related to risk factors, material disclosures, and due diligence reviews in corporate transactions, SEC filings, mergers and acquisitions, and clinical trial agreements.

Education

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

Bar and Court Admissions

BAR ADMISSIONS
  • Maryland
  • District of Columbia
COURT ADMISSIONS
  • U.S. District Court for the District of Maryland

Experience

MEDICAL DEVICES
  • 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.
  • Assisted medical device companies in navigating FDA regulatory requirements and policies for digital therapeutics.
  • Counseled a start-up device 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.
  • Successfully represented a device manufacturer before FDA in a compliance matter involving the distribution of certain ophthalmic devices.
  • Guided the maker of an IVD test kit in resolving FDA compliance matters involving labeling, tracking, and reporting, including the handling of several recalls.
  • Conducted an internal investigation of a subsidiary device company into potential wrongful conduct in the distribution of certain diagnostic products and developed recommendations for appropriate corrective actions and reports to FDA; facilitated discussions with FDA to help ensure ongoing compliance and avoid enforcement action. 
  • Assisted the manufacturer of a medical device during an FDA inspection, respond to a Warning letter, and conduct a recall, ultimately addressing all of FDA’s concerns.
  • Assisted a medical device manufacture submit a Pre-Sub meeting request and package and submit a 510(k) for a novel medical device to treat an orthopedic condition. 
PHARMACEUTICALS
  • 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.
  • Guided a pharmaceutical company in defending its FDA breakthrough therapy designation through agency appeals process.
  • 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.
  • Reviewed the promotional materials of a specialty pharmaceutical company that manufactures dermatology products and assisted the company in developing a strategy to obtain approval to co-package products.
  • Prepared and oversaw the development of clinical trial agreements in the U.S., and a dozen other countries for the conduct of Phase III clinical studies to obtain FDA approval of a pharmaceutical treatment.
BIOLOGICS
  • Assisted one of the largest biologics companies in South Korea successfully address a manufacturing compliance matter before the FDA. 
  • Counseled a company developing a gene therapy product to treat rare ocular conditions in FDA regulatory matters and prepared and reviewed clinical trial agreements and informed consent forms.
  • Assisted the maker of a monoclonal antibody biosimilar product successfully navigate an Advisory Committee meeting at FDA. 
  • Guided a biologics company in its interactions with the CBER review division and CBER’s Office of Compliance. 
  • Advised a biopharmaceutical company on issues related to its first product launch, including the review of SEC filings and promotional materials.
  • Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
  • 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”).
  • Counseled a regional eye bank on the regulatory status of autologous serum eye drops.
  • Assisted an eye bank developing a carrier for ocular HCT/Ps respond to an FDA compliance query. 
  • Helped an HCT/P manufacturer successfully address compliance questions before the State of Florida on a questions involving the scope of FDA’s authority and the regulatory status of its HCT/P product.
  • Prepared submissions to the FDA’s Tissue Reference Group for clients manufacturing a variety of HCT/Ps.
  • Prepared Pre-Requests for Designation to the FDA’s Office of Commination Products for several clients processing cellular-based, amnio-based, and other types of HCT/Ps.

Publications

  • “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)
FOLEY HOAG ALERTS & UPDATES
  • FDA Issues Safety Communication About Genetic Non-Invasive Prenatal Screening Tests April 25, 2022
  • FDA Updates Select Q&As on Biosimilar Regulation September 22, 2021
  • FDA Issues New Guidance to Developers of COVID-19 Vaccines June 30, 2020
  • FDA Issues New Guidance to Developers of COVID-19 Drugs and Biological May 13, 2020

Honors & Involvement

HONORS
  • Ranked by CHAMBERS USA: AMERICA'S LEADING LAWYERS FOR BUSINESS as one of the District of Columbia's leading Healthcare: Pharmaceutical/Medical Products Regulatory lawyers (2022) 
  • 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 (2008-2023)
  • 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

Speaking Engagements

  • “A New FDA Classification for Microbiome Sample Collection Devices: a Big Leap in Standardization,” 7th Annual Translational Microbiome Conference (April 2022)
  • “How are Manufacturers Handling CBD Labeling and Marketing Issues,” Legal and Practical Issues in the Evolving World of Cannabis Regulation Conference, FDLI  (November 2019)