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. She co-chairs the firm’s Food and Drug Law practice group and is resident in the firm's Washington, D.C. office. Areta draws upon almost 10 years of experience as Associate Chief Counsel for Drugs and Biologics and Assistant General Counsel for Litigation at the FDA to provide clients with nuanced counsel on FDA’s current views for meeting pre- and post-approval requirements.
Clients rely on Areta's counsel to identify the most viable and expedient regulatory pathways to get products to market and to identify and obtain all possible benefits, such as market exclusivities. When there are no clear pathways to market, Areta helps clients develop strategies to advance new technologies through the FDA review process. For example, Areta has helped clients advance clinical decision-support software, medical mobile applications, cellular and gene therapies, regenerative human tissue, and other personalized medicine products.
Areta has substantial experience helping clients develop compliance strategies and assess the risks of enforcement, as well as mitigate consequences of noncompliance. Her first-hand enforcement knowledge from the FDA has proven to be considerably useful when responding to 483s and warning letters, which can cover a wide range of post-approval and pre-approval issues, such as noncompliance with cGMP and cGTP regulations, adverse event reporting, recalls, and clinical trial data integrity.
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 all of a company’s manufacturing and marketing activities pending validation of the data. Among other things, Areta assists clients in conducting internal investigations into suspected wrongful conduct, implementing corrective actions, and working with the FDA to avoid or mitigate enforcement actions.
In addition, Areta has extensive experience with the FDA regulation of advertising and promotional activities for medical products, including the FDA’s restrictions on the promotion of off-label use. She carefully tracks related enforcement actions as well as court cases that address the limitations of FDA’s restrictions under 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.
