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ARETA L. KUPCHYK

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.

What do you focus on?

FDA Pathways to Market

I draw upon my experience as Associate Chief Counsel for Drugs and Biologics and Assistant General Counsel for Litigation at the FDA to provide my clients with nuanced counsel on FDA requirements to obtain necessary marketing authorization. My clients rely on me to identify the best and fastest regulatory pathways to get their products to market and to identify and obtain all possible benefits such as meetings with FDA officials and market exclusivity. I especially enjoy helping clients develop strategies to advance new technologies through the FDA review process, such as medical mobile applications, cellular and gene therapies and regenerative medical products to support the growth of personalized medicine.

Post-approval Compliance and Enforcement

I help my clients develop compliance strategies, assess the risks of enforcement, respond to agency warnings and actions and mitigate potential consequences. Clients appreciate my first-hand enforcement experience from the FDA, especially when responding to 483s and warning letters, which can cover a wide range of post-approval issues such as noncompliance with cGMP and cGTP regulations, adverse event reporting, recalls and data integrity, to name just a few. I assist clients in conducting internal investigations into suspected wrongful conduct and in implementing corrective action. My experience also enables me to assist with corporate transactions, due diligence reviews and product liability actions, all of which are inextricable from a client’s risk evaluation.

Advertising and Promotional Activities

I also focus on the FDA regulation of advertising and promotional activities, including the FDA’s restrictions on off-label use for medical products. Clients turn to me for reviews of promotional materials and marketing campaigns as well as advice on responding to agency inquiries and training employees.

What do you see on the horizon?

I see novel medical technologies emerging rapidly—even faster than the FDA and other federal and state regulators can understand and react to them. Gene therapies, use of stem cells and other personalized medicine therapies challenge the FDA and don’t neatly fit into the existing regulatory framework. Similarly, medical mobile applications, wireless devices and laboratory testing are being marketed and used despite the absence of FDA guidance. I expect the FDA to start addressing these issues in the immediate future, if not by guidance, then on a case-by-case basis by issuing warning letters.

Publications and Presentations

  • “FDA’s Authority to Regulate Pharmacy Compounding: Who’s Responsible?” Corporate Compliance Insights, January 16, 2013 (Author)
  • “Handling an FDA inspection: Dos, Don’ts and When to Call a Lawyer” Corporate Compliance Insights, August 20, 2012. (Author)
  • “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. (Author)
  • “Off-Label Communications: The FDA's Proposed Approach Product Liability”, Law & Strategy, July 1, 2012. (Author)
  • “Comment: FDA's Draft Guidance on Social Media and Off-Label Communications”, Bloomberg BNA Social Media Law & Policy Report, June 19, 2012. (Author)
  • “The Park Doctrine and AIP: Two Little-Known But Powerful FDA Enforcement Tools”, Corporate Compliance Insights, April 17, 2012. (Author)
  • “FDA’s Draft Guidance on Social Media and Off-Label Communications”, Bloomberg BNA, January 25, 2012. (Author)
  • “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. (Author)
  • “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)
  • “FDA’s Emerging Policy on Internet and Social Media Promotion of FDA-Regulated Medical Products,” Health Lawyers Weekly, December 2009. (Co-author)
  • “Prescription Drug and Medical Device Promotion—New FDA Draft Guidance on Presenting Risk Information,” Health Lawyers Weekly, June 2009. (Co-author)
  • “Comparative Effectiveness: Refining the Standards for FDA Approval and CMS Coverage,” Washington Legal Foundation Critical Legal Issues Working Paper, May 2009. (Co-author)
  • “Approval of Products for Human Use” and “Legal Requirements after Approval,” ABA’s Biotechnology and the Law, 2007. (Author)
  • “R&D 101: Legal Issues During Research and Development,” PLI’s Pharmaceutical Law 2006, Across the Product Life Cycle. (Co-author)
  • “Route to Market for Tissue and Cell-Based Therapeutics: The U.S. and Europe,” Practice Law Company (PLC): Cross-Border Life Sciences Handbook. (Co-author)
  • “Product Liability Protection for Stem Cell Research and Therapies: A Proposal,” The ABA Health Law Section: The Health Lawyer. (Co-author)
  • “Recall of Prescription Products: A Proactive Primer,” Food and Drug Law Institute, 2007. (Co-author)

Representative Experience

  • Counseled a national humanitarian non-profit organization with regard to the divestiture of its tissue business
    Counseled a national humanitarian non-profit organization 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”).

  • Assisted a medical device company navigate FDA regulatory requirements applicable to medical mobile applications
    Assisted a medical device company navigate FDA regulatory requirements applicable to medical mobile applications

  • Provided a pharmaceutical company, which was preparing to launch its first product, with counseling on its Standard Operating Procedure (“SOP”) reviews, and compliance.
    Provided a pharmaceutical company, which was preparing 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.

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  • 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”).
    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”). 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.
    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.
    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.

  • Reviewed the promotional materials of a specialty pharmaceutical company that manufactures dermatology products.
    Reviewed the promotional materials of a specialty pharmaceutical company that manufactures dermatology products. Also prepared an FDA expert in relation to an arbitration in which the client was involved. Additionally, developed a strategy for the client in seeking approval to co-package products.

  • Assisted a major medical device manufacturer with a comprehensive review and overhaul of its SOPs related to recalls and risk management.
    Assisted a major medical device manufacturer with a comprehensive review and overhaul of its SOPs related to recalls and risk management. Reviewed 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.

  • Counseled a start-up 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
    Counseled a start-up 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.

Media Clips

  • FDA's Biggest New Policies of 2014: Midyear Report
    Law360 | July 28, 2014
    Washington, DC, Health Care and Life Sciences partner Areta Kupchyk is quoted in this forward-looking feature story on new rules and guidance from the U.S. Food and Drug Administration making waves for drug and device makers.
  • What's Trending with Mobile Medical Apps and Health IT?
    Bloomberg BNA Health IT Law & Industry Report | July 21, 2014
    Washington, DC, Health Care and Life Sciences partner Areta Kupchyk authored this article discussing a potential new Food and Drug Administration framework for mobile medical apps and health IT. Click here to read the full article.
  • 5 Lessons Doctors Can Take From FDA's Big Stem-Cell Win
    Law360 | February 7, 2014
    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk discusses the DC Circuit Court’s stem cell oversight decision.
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  • Life Sciences Regulation and Legislation to Watch in 2014
    Law360 | January 1, 2014
    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk discusses FDA’s involvement in laboratory-developed testing, momentum on biosimilars, and possible further guidance on developing tailored medications.
  • Personalized Medicine Providers, FDA Has Your Back
    Law360 | December 8, 2013
    Boston Patents counsel Leena Karttunen Contarino and Washington, DC, Health Services and Life Sciences partner Areta Kupchyk authored this column discussing the U.S. Food and Drug Administration’s comprehensive personalized medicine report.
  • FDA's Stem Cell Oversight Faces Pivotal Test in DC Circ.
    Law360 | October 22, 2013
    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk discusses the importance of a DC Circuit case focused on the U.S. Food and Drug Administration’s power to regulate stem cell therapy.
  • 5 Takeaways from FDA's Unique Device ID Rule
    Law360 | September 27, 2013
    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk comments on the U.S. Food and Drug Administration’s final rule on unique device identification.
  • The Federal Regulation of Mobile Medical Apps
    Update: Food and Drug Law, Regulation and Education | July 1, 2013

    Health Services and Life Sciences partner Areta Kupchyk, Global Business & Transactions partner Mavis Yee, and Health Services and Life Sciences associate Carly Eisenberg authored this article on the need to balance the increasing use of mobile apps in the medical field with the need to protect the public. Click here to read the article online.

  • Plan B Saga Exposes FDA to Drug-Approval Suits
    Law360 | June 19, 2013

    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk discusses the U.S. Food and Drug Administration’s battle against wider access to Plan B emergency contraception.

  • FDA Cracking Down on Compounders at Historic Pace
    Law360 | April 22, 2013

    Washington, DC, health services and life sciences partner Areta Kupchyk provides commentary in this feature article discussing the U.S. Food and Drug Administration’s efforts to police the compounding pharmacy sector.

  • Medical Apps Get the Once Over from the FDA
    Marketplace | March 29, 2013

    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk discusses mobile medical apps and the FDA’s guidelines for approval.

  • FDA Seeks to Damp Criticism Over Mobile Health App Proposals
    Reuters | March 21, 2013

    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk discusses the U.S. Food and Drug Administration’s plans for regulating certain health care apps used on smartphones and tablets.

  • Medical App Makers Await Regulator Checkups
    The Recorder | March 15, 2013

    Silicon Valley Global Business & Transactions partner Mavis Yee and Washington, DC, Health Services and Life Sciences partner Areta Kupchyk are featured throughout this article noting that the mobile medical app industry is awaiting formal regulatory guidelines from lawmakers.

  • FDA's New Safety Reports Raise Tort Risks for Device Cos.
    Law360 | March 8, 2013

    Washington, D.C. health services and life sciences partner Areta Kupchyk discusses the Food and Drug Administration’s draft guidance intended to clarify when a change to a medical device should be considered a “recall” versus a “product enhancement.”

  • FDA's Authority to Regulate Pharmacy Compounding: Who's Responsible?
    Corporate Compliance Insights | January 16, 2013

    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk authored this column on the enforcement authority of the Food and Drug Administration (FDA) to regulate the creation of a particular pharmaceutical product to fit the unique needs of a patient. Click here to read the article.

  • Life Sciences Regulation to Watch in 2013
    Life Sciences Law 360 | January 1, 2013

    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk and Boston Government Investigations & Life Sciences partner Brian French discuss key life sciences industry regulations to watch in 2013.

  • FDA Marketing Rules Stretch to Drugmakers' Media Pitches
    Law 360 | November 13, 2012

    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk comments on the standard practice of the U.S. Food and Drug Administration to reprimand companies for any marketing efforts that seem to be unfair or misleading regardless if they are directed at consumers or the media.

  • Handling an FDA inspection: Dos, Don'ts and When to Call a Lawyer
    Corporate Compliance Insights | August 20, 2012

    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk authored this column discussing how to handle a facilities investigation by the Food and Drug Administration. Click here to read the article.

  • Drug, Device, and Biotechnology Manufacturing Requirements
    Corporate Compliance Insights | July 2, 2012

    This contributed article, authored by Washington, DC, Health Services and Life Sciences partner Areta Kupchyk, discusses the importance of compliance with current good manufacturing practice regulations established and enforced by the Food and Drug Administration. Click here to read the article.

  • Off-Label Communications: The FDA's Proposed Approach
    Product Liability Law & Strategy | July 1, 2012

    This article, authored by Washington, DC, Health Services and Life Sciences partner Areta Kupchyk and Buffalo Products associate Tracey Ehlers, discusses the Food and Drug Administration guidance addressing how drug, biologics, and medical device manufacturers should respond to unsolicited requests for off-label information, including—for the first time—communications via the Internet and social media.

  • Comment: FDA's Draft Guidance on Social Media and Off-Label Communications
    Bloomberg BNA Social Media Law & Policy Report | June 19, 2012
    Washington, DC, Life Sciences and Health Services partner Areta Kupchyk authored this article discussing the Food & Drug Administration’s long-awaited draft guidance on off-label use communications by drug, biologics, and device companies including, specifically, electronic communications using the Internet and social media.
  • Q&A With Nixon Peabody’s Areta Kupchyk
    Life Sciences Law 360 | May 23, 2012

    This Q&A focused on the life sciences industry is conducted with Washington, DC, Health Services and Life Sciences partner Areta Kupchyk.

  • The Park Doctrine and AIP: Two Little-Known But Powerful FDA Enforcement Tools
    Corporate Compliance Insights | April 17, 2012

    Washington, DC, Health Services and Life Sciences partner Areta Kupchyk authored this column addressing two enforcement tools used by the Food and Drug Administration (FDA) in response to violations. Click here to read the article.

  • Stem Cells, FDA, and the Edge of Science: Three Expert Viewpoints
    Forbes | February 19, 2012

    This feature article discusses the challenges with regulating stem cell product development. Washington, DC, Health Services and Life Sciences partner Areta Kupchyk discusses the difficulties involved with regulating cell-based products.

  • FDA’s Draft Guidance on Social Media and Off-Label Communications
    Bloomberg BNA | January 25, 2012
    This contributed article, authored by Washington, DC, Health Services and Life Sciences partner Areta Kupchyk, discusses the draft guidance issued by the FDA about off-label use communications by drug, biologics, and device companies including, specifically, electronic communications using the Internet and social media.
  • Nixon Peabody Wins Over FDA Insider From Reed Smith
    Law 360 | December 5, 2011

    This feature article highlights the arrival of Washington, DC, Health Services and Life Sciences partner Areta Kupchyk.

  • Reed Smith Attorney in D.C. Jumps to Nixon Peabody
    National Law Journal/Blog of Legal Times | November 28, 2011

    This article highlights the arrival of Washington, DC, Health Services and Life Sciences partner Areta Kupchyk.

Ideas

The FDA announces long-awaited draft social media guidance for drug and medical device industry
FDA Alert | June 18, 2014

The FDA proposes expansion of five-year marketing exclusivity for new chemical entities
Pharmaceutical, Medical Device and Life Sciences Alert | March 6, 2014

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Federal court keeps stem cell products under FDA's rule
Pharmaceutical, Medical Device And Life Sciences Alert | February 11, 2014

What You Need to Know About the Personalized Medicine Report by FDA
FDA Law Alert | November 5, 2013

FDA moves urgently to restrict the use of Fecal Microbiota Transplants for the treatment of diseases
FDA Alert | July 22, 2013

FDA asks medical device industry to identify and mitigate cyberattack risks
Pharmaceutical, Medical Device & Life Sciences Alert | June 18, 2013

Recall or product enhancement? Medical device manufacturers invited to comment on proposed FDA guidance
Pharmaceutucal, Medical Device & Life Sciences Alert | February 26, 2013

Webinar Recording: The First Amendment and Off-Label Promotion: Understanding the Implications of U.S. v. Caronia
Originally recorded December 5, 2012 | December 6, 2012

FDA seeks comments before making custom device policy changes required by Congress
FDA/Health Alert | November 20, 2012

The new medical device excise tax: Four things to consider before 2013
Tax Alert | November 16, 2012

Federal regulation of pharmacy compounding: FDA enforcement poses new risks to pharmacists and health care providers
FDA Alert | November 2, 2012

Webinar Recording: Knock Knock: Are you Prepared When the FDA Shows Up at Your Door?
Originally recorded September 27, 2012 | October 2, 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

FDA issues biosimilar draft guidance
FDA Alert | February 28, 2012

FDA's draft guidance on social media and off-label communications
FDA Alert | January 26, 2012

Webinar Recording: Recent Developments in the Regulation of Off-Label Communications
January 17, 2012

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Areta L. Kupchyk,Areta Kupchyk,FDA,U.S. Food And Drug Administration,FDA Regulatory,Medical Mobile Applications,Medical Device Software,Cellular And Gene Therapies,Biomarkers,Regenerative And Personalized Medicine Products,FDA Compliance,FDA Enforcement,Adverse Event Reporting,Initiating And Managing Recalls,Responses To 483s,Warning Letters,CGMP Inspections,Import/export Requirements,FDA-related Litigation,Regulatory Due Diligence,Product Liability,GMP,GTP