Areta Kupchyk has joined Foley Hoag LLP as a partner in the firm’s Washington D.C. office, where she will practice Food and Drug Administration (FDA) law. She will co-chair the firm’s Food and Drug Law practice, along with partner Paul Kim.
Kupchyk is a former FDA Associate Chief Counsel for Drugs and Biologics and Assistant Chief Counsel for Litigation. She provides nuanced counsel on FDA requirements to companies in the biotechnology, medical device, pharmaceutical and health care industries, as well as institutions, researchers and investors.
Kupchyk guides clients to the optimal regulatory pathways for getting products to market. She has counseled clients on developing strategies to move products such as medical mobile applications, cellular and gene therapies, and regenerative medical products through FDA review. Kupchyk also is experienced in advising clients on compliance issues; assessing the risk from enforcement actions; responding to FDA warnings and actions; and mitigating the consequences of enforcement actions.
Kupchyk regularly meets with FDA staff on legal and policy arguments in rulemaking proceedings and represents clients on challenging regulation in litigation. Clients turn to her for review of promotional materials and marketing campaigns, as well as advice on responding to FDA inquiries and employee training. She also advises on corporate transactions, due diligence reviews and product liability actions.
Kupchyk’s experience expands the firm’s life science focus by providing additional depth of FDA services. Her practice complements an existing nationally ranked team of healthcare lawyers and policy specialists known for providing Medicare and Medicaid reimbursement counseling and solutions to regulatory issues before the Centers for Medicare and Medicaid Services.
Kupchyk has written and spoken extensively about FDA processes. She authored two of the four chapters in the book “Medical Biotechnology: Premarket and Postmarket Regulation,” published by the American Bar Association Section of Science and Technology Law. She is listed in “The Best Lawyers in America 2016” in biotechnology and FDA Law.
Kupchyk earned a Bachelor of Arts degree from the University of Maryland and a law degree from the University of Maryland School of Law. She comes to Foley Hoag from Nixon Peabody LLP, where she was a partner in the firm’s Washington, D.C. office.
Source: www.foleyhoag.com
