Areta L. Kupchyk
Partner
- T:
- +1 202 414 9362 (Washington, D.C.)
- F:
- +1 202 414 9299 (Washington, D.C.)
- E:
- akupchyk@reedsmith.com
- Vcard
Areta is a member of the Life Sciences Health Industry Group, practicing in the area of health care regulatory law. Areta’s practice focuses on FDA regulatory issues. Areta counsels on drug, device, biologics, and biotechnology matters. Her experience includes product application, human cellular and tissue product regulation, pharmacogenomics and drug codevelopment with in vitro diagnostics (IVDs), xenotransplantation, clinical trial, and fast track approvals and submissions. She also has extensive experience with the regulation of advertising and promotional materials, adverse event reporting, including (ADE, SAE, MDR & AER), and drug distribution under the PDMA. Areta provides real-time counseling for many compliance issues, including GMP inspections, 483 and warning letter responses, and recall orders. She also has extensive experience with the application integrity policy (AIP) and debarments.
Areta has received numerous awards, including the prestigious FDA Commissioner's Special Recognition Award, the HHS General Counsel's Leadership Award, and the HHS Secretary’s Award for Distinguished Service. She is a three-time recipient of the FDA Commissioner's Special Citation for outstanding achievement. Areta also was recognized during her last year at FDA for outstanding achievement in developing a regulatory framework for human cellular and tissue-based products and for developing industry guidance on pharmaceutical products produced in bioengineered plants.
Representative Matters
Counseled the American Red Cross with regard to the divestiture of its tissue business, which was 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”).
Provided a pharmaceutical company, which is getting ready to launch its first product, with counseling on its Standard Operating Procedure (“SOP”) reviews and compliance. Also assisted them in developing a strategy to work with FDA as they negotiated approval issues, and reviewed their launch materials for compliance with advertising and marketing regulations.
- Counseled one of the world’s largest pharmaceutical manufacturers on potential fraud in the manufacturing process and successfully negotiated with the FDA to avoid Application Integrity Policy (“AIP”). We also provided extensive GMP training to the personnel.
Advised a biopharmaceutical company on issues related to its first product launch, including working with its transactional team reviewing SEC filings and promotional materials.
Assisted a pharmaceutical manufacturer with its FDA application process, and was able to successfully get approval of one of its products as a hybrid generic
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Publications
- Areta frequently writes health care client memos and contributes to various firm newsletters.
- Author of chapters entitled "Approval of Products for Human Use" and "Legal Requirements After Approval" in ABA's Biotechnology and the Law 2007.
- Co-author of chapter entitled "R&D 101: Legal Issues During Research and Development" which appeared in PLI's Pharmaceutical Law 2006, Across the Product Life Cycle
- Co-authored "Route to Market for Tissue and Cell-Based Therapeutics: The US and Europe," which was published by the Practice Law Company (PLC) in a Cross-Border LifeSciences Handbook.
- "Product Liability Protection for Stem Cell Research and Therapies - A Proposal," which appeared in The ABA Health Law Section: The Health Lawyer, Volume 18, Number 1
- Co-author of "Recall of Prescription Products: A Proactive Primer," Food and Drug Law Institute, 2nd Edition (2007).
Speeches / Presentations
- Presenter in various forums including FDLI and FDA's in-house training on several FDA regulatory issues, such as the regulation of marketing and advertising, clinical trials, and AIP (2003 - Present)
Experience
| 2003 | Reed Smith |
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| 1995 | Food and Drug Administration Associate Chief Counsel for Biologics, Associate Chief Counsel for Drugs and Assistant General Counsel for Litigation. Contributed significantly to the development of some of FDA's most dynamic issues, including policy on bioengineered plants grown to produce materials for biologics, drugs and devices, BSE-related enforcement, vaccine development, CGMP compliance, xenotransplantation, and fast-track approvals. Worked extensively on FDA human cellular and tissue-based product, combined products, devices related products, and regulations. |
| 1994 | Federal Trade Commission |
| 1993 | Food and Drug Administration |
| 1989 | Judicial clerkship for the Honorable Hilary D. Caplan, Circuit Court for Baltimore City |
| — | Maryland Attorney General’s Office – Assistant Attorney General |
Legal Education
| 1990 | J.D., with honors, University of Maryland School of Law Order of the Coif |
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Undergraduate Education
| 1979 | B.A., University of Maryland Baltimore County, American Studies |
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Professional Admissions / Qualifications
- District of Columbia
- Maryland
Court Admissions
- State Court of Appeals - Maryland
- U.S. District Court - District of Maryland
Professional Affiliations
- Food and Drug Law Institute
- Maryland State Bar Association
Interests
In her spare time, Areta champions L’Arche DC, a local chapter of an international organization of developmentally disabled adults living together in an ecumenical, faith-based community with non-developmentally disabled adults. Areta also enjoys golf and collecting art.
Awards, Honors and Recognitions
- Named as one of America's leading lawyers in Biotechnology Law in The Best Lawyers in America (2008-2010 editions). The Best Lawyers lists, representing 80 specialties in all 50 states and Washington, D.C., are compiled through an exhaustive peer-review survey in which thousands of the top lawyers in the United States confidentially evaluate their professional peers.