Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.
FDA’s Digital Health Advisors Acknowledge Benefits of Mental Health Chatbots, Urge Caution Around Diagnoses
What is happening: FDA’s Digital Health Advisory Committee met virtually on November 6, 2025 to learn about and discuss generative artificial intelligence (gen AI)–enabled digital mental health devices. The independent advisors appeared to agree that there is value in using gen AI for mental health care, whether as patient-facing chatbots or professional-facing tools. At the same time, there was broad consensus that clear and robust regulatory controls and guidelines on the design, development, testing, authorization, deployment, and monitoring of such devices is critical for adequate risk mitigation.
Presenters and advisors generally agreed on the following guiding principles for this next frontier in digital care:
- “Professional in the loop.” A patient diagnosed with a mental health condition and using a gen AI–enabled medical device should always be monitored by a licensed physician. Engagement between the patient and the overseeing physician, including for initial diagnosis, introduction to the gen AI–enabled device, and periodic consultation, is necessary to avoid potential harm.
- Community engagement. Developers must work with mental health professionals, and perhaps patients, when designing and deploying gen AI–enabled mental health devices. Such efforts should ensure adequacy of training data, confirm validation protocols and clinical trial strategies, and address potential biases and use issues.
- Clinical trials, no 510(k). All gen AI–enabled mental health devices should be authorized through the De Novo classification or pre-market approval (PMA) processes because the 510(k) “substantial equivalence” pathway is inadequate for such devices. By the same token, all gen AI–enabled mental health devices should undergo randomized, controlled clinical trials to confirm safety and effectiveness.
- Post-market monitoring. FDA should monitor, and require developers of gen AI–enabled mental health devices to implement detailed plans for monitoring, the safety and performance of all such devices after commercialization.
- Additional caution with pediatric patients. For all gen AI–enabled mental health devices, extensive testing and real-world evidence of safe and effective use in adult patients are necessary before extending indications for use to patients under the age of 18.
Why it matters: Even though FDA has granted marketing authorization to nearly 1,250 AI-enabled medical devices to date, the agency has not yet authorized any gen AI–enabled medical devices or articulated a clear policy for handling their oversight. The Digital Health Advisory Committee’s inaugural meeting last year and this recent meeting, both focusing on issues relating to gen AI–enabled devices, highlight the regulatory challenges associated with such devices. It is too soon to assess the impact of the advisory committee meetings on FDA’s regulatory process for gen AI–enabled devices, but the committee members and professional community are persistently advocating for strong controls and oversight, which may lead the agency to develop higher authorization standards for certain types of gen AI–enabled devices. A recurring message throughout the November 6 advisory committee meeting was that gen AI–enabled mental health devices involve significant risks to patients and that the agency must carefully consider how to regulate such devices.
Who may be affected: FDA policies requiring large amounts of high-quality testing and clinical trial data, as well as robust post-market monitoring and deployment plans, for gen AI–enabled mental health devices would help mitigate the impact of such devices on mental health providers and mental health care practice in general, and would reduce risks for patients. On the other hand, such requirements would substantially raise the development cost of these types of devices, which could adversely affect developers and investors. All interested stakeholders should submit their written comments to FDA by December 8, 2025 through the e-docket.
Intoxicating Hemp-Derived THC Products Targeted by Congress, Reinforces FDA’s Position on Foods and Beverages
What is happening: Legislation signed by President Trump on November 12, 2025 expressly omits “hemp-derived cannabinoid products” — such as foods, beverages, and vaping liquids — from the existing federal definition of “hemp.” This major amendment to the Agricultural Marketing Act addresses a downstream consequence of Congress’s legalization of hemp in 2018, which unintentionally spurred the growth of consumer products containing delta-8 THC, delta-9 THC, and other intoxicating cannabinoids.
Although the text of the 2018 law stated FDA’s authorities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) were not being modified, such compounds were perceived as permissible under the law due to their ability to be synthesized from hemp plants. They were quickly added to a wide variety of consumer products that are subject to direct FDA regulation. But FDA has consistently maintained that human and animal foods, beverages, and dietary supplements cannot lawfully include such ingredients because of various provisions in the FD&C Act, meaning that interstate distribution of cannabinoid-derived food products is prohibited.
Why it matters: Since 2018, state governments and cannabis control agencies have taken different approaches to these types of intoxicating hemp-derived products, in some cases banning them entirely while in other cases restricting access by age or establishing potency limits. As reports of accidental overdoses and harms to children from such products have steadily increased, as well as reports of inaccurately labeled products and other instances of consumer deception, the pressure from certain stakeholders on Congress became overwhelming. For example, in October 2025, 39 attorneys general co-authored a letter to congressional leaders demanding a correction to the Agricultural Marketing Act that would “clarify the federal definition of hemp and prevent the continued sale of unregulated, intoxicating THC products.” Senate and House members responded in a bipartisan manner, widely affirming the amendment through their votes in mid-November and rejecting an attempt to have the language removed from the final bill sent to the president’s desk.
Who may be affected: Hemp-derived cannabinoids have become a big business throughout the country over the past several years, and many large and small businesses alike stand to be adversely affected by the narrowed federal definition of “hemp” and its additional clarity around what is excluded from that term. However, the amendment does not become effective until one year after the bill was signed into law, providing an opportunity for companies to examine and adjust their businesses accordingly to mitigate the potential damage to their bottom lines. As stakeholders continue to grapple with the legislation’s effects and some seek rescissions / revisions from Congress, companies should also keep a close eye on further developments in this space. Indirect reinforcement of FDA’s position that foods and beverages containing THC and other cannabinoids should not be in interstate commerce may also lead to an increase in agency enforcement activity with respect to such products.
Fifteen Commissioner’s Vouchers Granted, and More Coming, to Tackle National Priorities
What is happening: FDA has recently completed two rounds of Commissioner’s National Priority Voucher (CNPV) awards to a total of 15 drug and biologic manufacturers. The first announcement on October 16 included nine companies, and the second on November 6 included six companies. In some cases, the companies that received vouchers had already submitted their product’s marketing application, but each recipient is entitled to an expedited review for their application, estimated to take one to two months.
Why it matters: Since creating the CNPV program earlier in the year, the agency has moved quickly to review companies and investigational products as candidates for the new vouchers and to award them based on perceived alignment with the Trump administration’s national policy priorities. FDA’s speed highlights the CNPV program as a key tool for the agency to expedite approval of new drugs or indications for existing products that advance certain US interests. Although neither FDA nor many of the awardees describe the national priority that each company or product supports, in some situations the award appears to be linked to a commitment from the company to sell their products through the TrumpRx direct-purchasing platform. While it remains to be seen whether FDA can accomplish its goal to approve applications under the voucher program within one to two months, if the agency can reliably deliver such approvals, the CNPV program will represent a highly attractive method to reduce review times and increase company and product value.
Who may be affected: All drug and biological product manufacturers and investors should pay close attention to any FDA or voucher awardee announcements concerning the products being reviewed under the CNPV program. Commissioner Makary has recently indicated that another round of awards will be coming soon, and requests for consideration can be made at any time, suggesting that there is currently no plan for capping the number of vouchers granted in a given year. If the vouchers actually lead to substantially reduced time to product approval, manufacturers may want to consider aligning their facilities and/or product candidates with the CNPV program priorities described on FDA’s website.
FDA Seeks to Expedite Biosimilar Approval Actions, Reduce Development Costs
What is happening: After over a decade of experience reviewing biosimilar applications and the data supporting them, FDA recently announced that for many of these products, a comparative clinical study testing the proposed biosimilar against its reference biological product will not be required. Such comparative clinical studies were previously recommended whenever there was “residual uncertainty about whether there are clinically meaningful differences” between the proposed biosimilar and its reference product, after all nonclinical work and comparative analytical studies had been completed. Because modern analytical technologies are more precise and accurate than they were in 2010 when Congress enacted the biosimilar statute, comparative analytical assessments (CAAs) are generally more sensitive in identifying differences between two products than what can be gleaned from the results of a comparative efficacy study (CES). Thus, a CES is unlikely to be scientifically informative to FDA’s evaluation of a proposed biosimilar and its approvability, often rendering the CES unnecessary.
Why it matters: Without the potential requirement of a CES as part of the complete data package for a new biosimilar application, companies working on proposed biosimilars will be able to allocate smaller development budgets to individual products. Correspondingly, there may be a greater willingness from investors to allocate capital to such companies and products, which could spur an increase in the number of biosimilars that make it through development and on to the FDA review and approval process. Indeed, since the agency’s announcement at the end of October, at least one Indian developer of generic and biosimilar drugs has stated that its costs per a single complex biosimilar will drop by 50% as a result of the change.
Who may be affected: Biosimilar product developers, their investors, and US patients and health care providers all stand to benefit from the formalized agency decision to streamline clinical data requirements for many biosimilars. If the reduced requirement for CES data can increase the number of available FDA-approved biosimilars, providers and patients will have more choices and the prices for both reference and biosimilar biological products may decrease. Ultimately, a more competitive marketplace should improve both patient access and continuity of care, providing strengthened returns on investment.
Removal of Boxed Warnings from HRT Products May Spark R&D Investment
What is happening: On November 11, 2025, FDA publicly announced that owners of approved hormone replacement therapy (HRT) products should remove class-wide boxed warnings about potential risks of cardiovascular disease, breast cancer, and dementia from HRT products’ prescribing information. The decision is controversial in part due to the agency’s rejection of the typical public notice-and-comment opportunities for significant policy changes and non-disclosure of the “comprehensive review of the scientific literature” that FDA apparently conducted to support its action. Despite questions of scientific merit, this agency action will almost certainly spark a renewed interest in the development of new HRT products for the treatment of menopausal symptoms in women.
Why it matters: Accelerating public awareness of menopause as a unique period in a woman’s health journey has also led to an increase in demand for effective treatments and the need for more research into the complex interplay of systemic hormones and the risk of chronic diseases associated with aging, such as dementia and heart disease. Changes to the prescribing information for HRT products to reduce safety warnings for patients and their physicians may make long-term randomized controlled trials and other research projects easier to fund and complete.
Who may be affected: Developers of new HRT products, as well as companies marketing currently approved products, and their investors are likely to be the most enthusiastic recipients of the FDA’s recently articulated benefit-risk standard for such products. Researchers interested in exploring and effectively documenting the actual benefits and risks of HRT may also gain a boost from FDA’s requested safety labeling revisions.
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