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Christina Kuhn

Christina Kuhn advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products.

Christina frequently helps multinational device manufacturers as well as start-up device companies navigate the premarket regulatory process, advising companies on regulatory classification, clinical development strategy, and agency interactions. She also has significant experience counseling medical device companies on postmarket compliance requirements, including those related to advertising and promotion, quality systems and manufacturing, medical device reporting, registration and listing, and recalls. She advises clients on responding to and resolving enforcement actions, such as FDA inspections and Warning Letters as well as Department of Justice investigations.

Christina advises clients on, and performs regulatory due diligence for, corporate transactions, including acquisitions, public offerings, co-development agreements, and clinical trial agreements.

Christina also regularly assists industry associations and medical device and pharmaceutical companies in commenting on FDA guidance documents and rulemaking as well as drafting and analyzing federal legislation.

Christina is a frequent contributor to Covington’s Digital Health and InsideMedicalDevices blogs.

On February 19, 2025, President Trump issued an Executive Order titled “Ensuring Lawful Governance and Implementing the President’s ‘Department of Government Efficiency’ Deregulatory Initiative” (the EO). The stated purpose of the EO is to advance the Administration’s policies of focusing executive enforcement actions on regulations “squarely authorized by federal statute” and deconstructing the administrative state in order to achieve the stated goal of “[e]nding Federal overreach and restoring the constitutional separation of powers.” The EO appears to present opportunities for FDA-regulated stakeholders to identify certain regulations, guidance, and enforcement actions for recission or termination. Likewise, certain stakeholders may face changes in the competitive balance with competitors if the EO causes FDA to stop enforcing regulations that currently prohibit the marketing of certain products. 

Key Provisions of the EO

In order to effectuate the stated policy, the EO provides for 1) the rescission of existing regulations across federal agencies, 2) the de-prioritization and termination of certain ongoing enforcement actions, and 3) the review of new regulations by members of the Department of Government Efficiency (DOGE) and the Administrator of the Office of Information and Regulatory Affairs (OIRA):

  1. “Rescinding Unlawful Regulations and Regulations That Undermine the National Interest”: The EO directs agency heads, in coordination with their DOGE team lead and the Office of Management and Budget (OMB) Director, to, within the next 60 days, review all agency regulations and identify regulations deemed to be 1) unconstitutional, 2) unlawful, 3) based on “anything other than the best reading of the underlying statutory authority or prohibition,” 4) implicating “matters of social, political, or economic significance that are not authorized by clear statutory authority,” 5) excessively costly, 6) “harmful to the national interest,” or 7) overly burdensome for small businesses or entrepreneurs. Notably, and consistent with the Administration’s other recent deregulatory actions, the EO defines “regulations” to include guidance documents. The EO states that the Administrator of OIRA, in consultation with agency heads, will then develop a Unified Regulatory Agenda to rescind or modify the identified regulations. Pursuant to this mandate, FDA will likely be expected to conduct a broad review of its regulations and guidance documents over the next 60 days and identify items that may merit rescission.
  2. “Enforcement Discretion to Ensure Lawful Governance”: The EO grants agency heads discretion to “preserve their limited enforcement resources” by 1) de-prioritizing enforcement of regulations that are “based on anything other than the best reading of a statute” or “that go beyond the powers vested in the Federal Government by the Constitution”; and 2) to terminate ongoing regulatory enforcement proceedings which “do not comply with the Constitution, laws, or Administration policy.” This, in turn, could pose significant implications for both future and ongoing FDA enforcement actions. Under the EO, even long-standing precedents that provide the foundation for FDA’s enforcement activities could be scrutinized if the Administration considers them to be not based on the current “best” reading of a statute. In practical terms, this could lead to the truncation or effective deletion of certain long-standing regulatory requirements across all product areas regulated by FDA. 
  3. “Promulgation of New Regulations”: The EO requires that agency heads consult with their DOGE Team Leads and the Administrator of OIRA on potential new regulations as soon as practicable and instructs DOGE Team Leads and OIRA to evaluate potential new regulations against certain criteria outlined in the EO.

Continue Reading Executive Order on Deregulatory Initiative: What it Means for Food, Cosmetic, Drug, and Device Stakeholders

October 29, 2024, Covington Alert

This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.

During the third quarter of 2024 FDA’s Office of Prescription Drug Promotion (OPDP) posted the following three untiled letters.

  • Untitled Letter to AbbVie, Inc. re NDA 211765 UBRELVY (ubrogepant) tablets, for oral use (August 29, 2024) (Ubrelvy Untitled Letter)
  • Untitled Letter to Mirati Therapeutics Inc. (a Bristol Myers Squibb Co.) re NDA 216340 KRAZATI™ (adagrasib) tablets, for oral use MA 166 (August 1, 2024) (Krazati Untitled Letter)
  • Untitled Letter to Kaleo, Inc. re NDA 201739 AUVI-Q® (epinephrine injection, USP), for intramuscular or subcutaneous use MA 1021 (July 17, 2024) (Auvi-Q Untitled Letter)

The Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) and the Office of Medical Device and Radiological Health Operations (OMDRHO) in the Office of Regulatory Affairs (ORA) did not post any warning letters relating to the advertising and promotion of medical devices during this period. FDA’s Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality (OCBQ) has not posted any enforcement letters since 2018.

This alert merely summarizes the allegations contained in FDA’s letters. It does not contain any analyses, opinions, characterizations, or conclusions by or of Covington & Burling LLP. As a result, the information presented herein does not necessarily reflect the views of Covington & Burling LLP or any of its clients.Continue Reading FDA Advertising and Promotion Enforcement Activities: Update

On September 6, Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, issued a white paper about the oversight and legislative role of Congress related to the deployment of artificial intelligence (AI) in areas under the HELP Committee’s jurisdiction, including health and life sciences.  In the white paper, Senator Cassidy disfavors a one-size-fits-all approach to the regulation of AI and instead calls for a flexible approach that leverages existing frameworks depending on the particular context of use of AI.  “[O]nly if our current frameworks are unable to accommodate . . . AI, should Congress look to create new ones or modernize existing ones.”  The Senator seeks public feedback on the white paper by September 22, 2023.  Health care and life sciences stakeholders should consider providing comments. 

This blog outlines five key takeaways from the white paper from a health care and life sciences perspective. Note that beyond health and life sciences issues, the white paper also addresses considerations for other areas, such as use of AI in educational settings and labor/employment implications created by use of AI.


5 Key Takeaways for AI in Health Care and Life Sciences

The white paper – entitled “Exploring Congress’ Framework for the Future of AI: The Oversight and Legislative Role of Congress Over the Integration of Artificial Intelligence in Health, Education, and Labor” – describes the “enormous good” that AI in health care presents, such as “the potential to help create new cures, improve care, and reduce administrative burdens and overall health care spending.”  At the same time, Senator Cassidy notes that AI presents risks that legal frameworks should seek to minimize.  Five key takeaways from the white paper include:Continue Reading Framework for the Future of AI: Senator Cassidy Issues White Paper, Seeks Public Feedback

On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies.  These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device.  In parallel, FDA also updated four previously


Continue Reading FDA Issues Updated Guidance on the Regulation of Digital Health Technologies