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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Areta has substantial experience helping clients develop compliance strategies and mitigate consequences of noncompliance. Her first-hand enforcement knowledge has enabled clients to respond effectively and successfully to Inspectional Observations (483s), and Warning Letters, Untitled Letters, which can cover a wide range of pre- and post-approval issues, such as noncompliance with current Good Manufacturing Practice regulations and the Quality System Regulation, adverse event reporting, and data integrity. Areta also helps clients traverse the complex requirements for import and export of medical products and assists companies faced with import detentions. Areta also has extensive experience handling recalls for medical and food product.
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, which could halt substantive review of marketing applications pending validation of data. Among other things, Areta assists clients in conducting internal investigations into suspected wrongful conduct and implementing corrective actions.
Areta's practice also includes the FDA regulation of advertising and promotional activities for drug and device products, cannabis and CBD products, dietary supplements, and cosmetics. She carefully tracks the enforcement actions involving the First Amendment’s protection of commercial free speech.
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, and mergers and acquisitions.
Areta recently authored two important chapters in Medical Biotechnology: Premarket and Postmarket Regulation, published by the American Bar Association Section of Science and Technology Law, titled “Approval of Biotechnology Products for Human Use” and “Federal and State Regulation After Approval.”