SCOTUS Weighs Trump Administration’s Tariff Authority Under IEEPA; Pharma and Device AI; and More

Biopharma & Medical Devices Briefing

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At a Glance

The general consensus of those who attended or listened to the Supreme Court's oral arguments was that the Justices appeared to be skeptical of whether IEEPA allows for the imposition of tariffs. Therefore, Supreme Court watchers are now thinking that it is possible the Supreme Court will hold that President Trump did not have the authority to issue the tariffs.
The Food and Drug Administration (FDA) has announced a public comment period to gather input on how best to evaluate the safety, effectiveness and reliability of AI-enabled medical devices used in clinical settings, with responses due by December 1, 2025.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has recently issued a draft quality guideline for public comment addressing risk assessment and control of leachables. Over the last several years, leachables have been an area of high FDA scrutiny, initially for pharmaceuticals and biologics, and more recently for devices.
In October 2025, FDA and the Center for Research on Complex Generics held a workshop, Modeling and Artificial Intelligence (AI) in Generic Drug Development and Product Lifecycle Management: Regulatory Insights and Future Trends. Speakers, panelists and the audience mentioned areas where AI could be, or is already being, integrated into current processes.

The Latest on Tariffs: Supreme Court Weighs Trump Administration’s Authority Under IEEPA

The biggest trade news from the first week of November 2025 are the oral arguments before the Supreme Court concerning whether President Trump has the authority under the International Emergency Economic Powers Act (IEEPA) to impose tariffs. However, the pharmaceutical, life sciences and medical device sector is also monitoring for any rumors of the Section 232 report on pharmaceutical products being finalized or whether the administration will initiate a Section 301 investigation into drug pricing as a method of imposing targets, as well as the progress of the Section 232 investigation into medical devices.

First, on Wednesday, November 5, the Supreme Court heard oral arguments in the appeal of the case where the Court of Appeals for the Federal Circuit held that President Trump did not have the authority to impose tariffs under IEEPA. The general consensus of those who attended or listened was that the Justices appeared to be skeptical of whether IEEPA allows for the imposition of tariffs. Therefore, Supreme Court watchers are now thinking that it is possible the Supreme Court will hold that President Trump did not have the authority to issue the tariffs. U.S. Trade Representative Jamieson Greer told reporters that the administration would be ready to refund the tariffs imposed pursuant to IEEPA if that were the case.

Second, despite President Trump posting on Truth Social in late September that tariffs of 100% would be imposed on pharmaceutical products beginning in October, those tariffs have yet to be announced. Sources say that, as of that posting, the Commerce Department had not yet written the Section 232 report finalizing its investigation, which is necessary for President Trump to issue the tariffs. Moreover, there is some confusion as to when or if those 232 tariffs on pharmaceuticals will be announced, what types of pharmaceutical products they will apply to (i.e., generic, branded, patented, nonpatented). The EU Trade Deal did provide duty relief for certain nonpatented pharmaceutical products from the reciprocal IEEPA tariffs on EU-origin products; however, many of those pharmaceutical tariff classifications remain on the “Annex II” list, which is exempt from reciprocal tariffs regardless of their patented status. This confusion prompted rumors that the Trump administration — potentially in lieu of, or in addition to, the Section 232 tariffs — would begin a Section 301 report into pharmaceutical pricing to impose other fees/tariffs on pharmaceutical products.

Finally, in late September, the Department of Commerce requested comments for a Section 232 investigation into whether imports of medical devices, personal protective equipment (PPE), and other medical products other than pharmaceuticals are harming the domestic industry’s ability to manufacture those items. This request for comments indicated that the Section 232 investigation commenced on September 2, 2025. Thus, the Department of Commerce has until May 30, 2026, to finalize this report (it is unclear whether the shutdown will affect these deadlines), after which President Trump will have 90 days to decide what action to take. Of course, the Department of Commerce and President Trump may move faster than these deadlines, so it is important to continue monitoring for the results of this investigation.

AI-Driven Medical Devices: FDA Requests Public Comment

The Food and Drug Administration (FDA) has announced a public comment period to gather input on how best to evaluate the safety, effectiveness and reliability of AI-enabled medical devices used in clinical settings, with responses due by December 1, 2025. This initiative, led by FDA’s Digital Health Center of Excellence, seeks feedback from industry, clinicians and researchers on performance metrics, monitoring methods and data sources relevant to both premarket review and postmarket surveillance. The agency is also requesting input on best practices for validating and continuously monitoring AI algorithms, especially those that are adaptive or learning, along with strategies for ensuring transparency, explainability and reliability in clinical use. Read more here.

ICH Draft Guideline: Risk Assessment and Control of Leachables in New Drug Products

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has recently issued a draft quality guideline, ICH Q3E or “Guideline for Extractables and Leachables,” for public comment. The guideline addresses risk assessment and control of leachables in new drug products, including cell and gene therapies, and drug device combination products meeting the definition of pharmaceutical or biological products. Leachables are nondrug-related impurities that have migrated into a drug product under in-use conditions from the product’s packaging and/or device components. Another source of leachables, particularly in biologics, is through aspects of the manufacturing process utilizing single-use systems. Over the last several years, leachables have been an area of high FDA scrutiny, initially for pharmaceuticals and biologics, and more recently for devices.

Modeling and AI in Generic Drug Development and Product Lifecycle Management: FDA and CRCG Public Workshop

On October 15-16, 2025, FDA and the Center for Research on Complex Generics (CRCG) held a workshop, Modeling and Artificial Intelligence (AI) in Generic Drug Development and Product Lifecycle Management: Regulatory Insights and Future Trends. Speakers, panelists and the audience mentioned a number of areas where AI could be, or is already being, integrated into current processes, such as:

Increasing consistency of regulatory reviews, FDA communications within the agency, and review efficiency
Drug Master Files
Drug Development Technologies
Biomarkers
Physiologically based pharmacokinetic modelling (PBPK)
Molecular dynamics predictions of aggregation patterns
Compliance with the U.S. Drug Supply Chain Security Act (DSCSA)
Data integrity checks — for example, to see if the pharmacokinetics data in a submitted abbreviated new drug application (ANDA) follows the patterns known for a given drug
Biopharmaceutics Classification System (BCS) determinations
Use of GenAI for validation of mechanistic models
Impact analysis and risk assessment
Knowledge-Aided Assessment and Structured Application (KASA) — for example, FDA is exploring using large language models (LLM) to transform the unstructured or inconsistently formatted data in ANDA submissions into structured data in the format required by FDA’s KASA.

A representative from the European Medicines Agency (EMA) added that EMA had started preliminary discussions on a growing number of initiatives involving AI. Some of these are highlighted on the agency’s website at Artificial intelligence | European Medicines Agency (EMA).

At the same time, some presenters stressed that no single AI model is capable of completing all tasks, and even for the same task, it could be beneficial to apply several different models and compare their outputs. Regulatory speakers encouraged industry to participate in various pilot programs and standardization efforts.

Workshop organizers indicated their intent to prepare and publish a report of this workshop and to potentially include discussion of questions submitted by the audience in that future publication.

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