Trump Administration Updates for the Life Sciences Industry Q1 2026
Executive Orders and Policy Updates
In the end of 2025 and the first quarter of 2026, the Trump administration and federal agencies have released a number of executive orders and other regulatory actions with potential impact for the life sciences industry. Some notable policy activities cover drug pricing and artificial intelligence ("AI") strategy. Some of the below actions remain the subject of ongoing litigation.
Artificial Intelligence
FDA Deploys Agentic AI Capabilities for Agency Employees to Improve Workflows
On December 1, 2025, the Food and Drug Administration ("FDA") announced the deployment of agentic AI capabilities for all agency employees to enable more complex AI workflows and multistep tasks, such as meeting management, pre-market reviews, post-market surveillance, inspections, compliance, and administrative functions. The agency also launched a two-month Agentic AI Challenge for staff to build agentic AI solutions and demonstrate these solutions at the FDA Scientific Computing Day in January 2026.
HHS Releases AI Strategy to Transform Agency Operations
On December 4, 2025, the U.S. Department of Health and Human Services ("HHS") released its AI Strategy, a department-wide initiative to integrate AI across internal operations, research, and public health. The strategy is built on five pillars: ensuring governance and risk management; designing infrastructure for user needs; promoting workforce development and burden reduction; fostering health research and reproducibility; and enabling care and public health delivery modernization. The strategy invites all HHS divisions—including the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services ("CMS"), FDA, and the National Institutes of Health—to collaborate in the development of one robust department-wide AI infrastructure.
FDA and EMA Issue Joint Guiding Principles of Good AI Practice in Drug Development
On January 14, 2026, FDA and the European Medicines Agency issued joint guiding principles of good practices when using AI to advance drug and biological product development. The 10 principles are tailored to the drug development cycle and emphasize the importance of: human-centric design, risk-based approach, adherence to standards, clear context of use, multidisciplinary expertise, data governance and documentation, model design and development practices, risk-based performance assessment, life cycle management, and clear, essential information.
Drug Development and Pricing
FDA Grants Approvals Under Commissioner's National Priority Voucher Program
On December 9, 2025, FDA granted its first approval under the Commissioner's National Priority Voucher pilot program, with a reported aim to strengthen domestic antibiotic manufacturing capacity. FDA granted additional approvals under the program on February 26, March 5, and March 19, 2026. FDA seeks public comment and scheduled a public hearing on the voucher program for June 4, 2026.
CMS Proposes Global Benchmark for Efficient Drug Pricing Model
On December 21, 2025, CMS proposed the Global Benchmark for Efficient Drug Pricing ("GLOBE") Model, a model, described as mandatory, that would assess a rebate for certain drugs payable under Medicare Part B if the prices exceed those in economically comparable countries. The GLOBE Model would launch October 1, 2026, and run through 2031.
CMS Proposes Guarding U.S. Medicare Against Rising Drug Costs Model
On December 21, 2025, CMS announced its proposal of the Guarding U.S. Medicare Against Rising Drug Costs ("GUARD") Model, a model, described as mandatory, that would assess a rebate for certain drugs payable under Medicare Part D if the prices exceed those in economically comparable countries. The GUARD Model would launch January 1, 2027, with the model's period of performance ending on December 31, 2033, and its payment period ending on December 31, 2035.
CMS Announces BALANCE Model to Expand Access to GLP-1 Medications
On December 23, 2025, CMS announced the voluntary Better Approaches to Lifestyle and Nutrition for Comprehensive Health ("BALANCE") Model to expand access to GLP-1 medications for Medicare Part D and Medicaid beneficiaries. Under the BALANCE Model, CMS will negotiate pricing and coverage terms with participating manufacturers on behalf of state Medicaid agencies and Medicare Part D plans. State Medicaid agencies can join the model beginning in May 2026, and Part D plans can join beginning in January 2027.
On January 27, 2026, CMS announced the selection of 15 high-cost prescription drugs covered under Medicare Part D and Medicare Part B for the third cycle of the Medicare Drug Price Negotiation Program. The 15 drugs primarily treat cancer, autoimmune and inflammatory conditions, HIV, diabetes, and respiratory disorders. On March 13, 2026, CMS announced that the manufacturers of the drugs selected for the negotiation program have chosen to participate. Negotiations with the manufacturers will reportedly occur in 2026, and any negotiated or renegotiated prices will take effect on January 1, 2028.
BARDA Opens Solicitations for a $100 Million Prize Program for Development of Novel Antivirals
On February 3, 2026, the Biomedical Advanced Research and Development Authority ("BARDA") opened solicitations for the Small Molecule Approaches for Rapid and Robust Treatment ("SMART") Antiviral Prize, a $100 million multistage competition to develop broad-spectrum, small-molecule antiviral therapies targeting viruses in the Togaviridae and Flaviviridae families, which include dengue, Zika, West Nile, and Chikungunya.
White House Announces Launch of Prescription Discount Website
On February 5, 2026, the Trump administration announced the launch of TrumpRx.gov, a website aimed at providing consumers discounted pricing for certain prescription drugs. The website currently offers coupons for consumers to pay out-of-pocket for specific drugs made by manufacturers that have reached pricing deals with the Trump administration.
HRSA Issues RFI on 340B Rebate Model Pilot Program
On February 17, 2026, the Health Resources and Services Administration ("HRSA") issued a request for information ("RFI") related to a potential 340B Rebate Model Pilot Program. The RFI seeks comments from stakeholders regarding "the potential use of rebates to effectuate the ceiling price under the 340B Program." The RFI followed a decision by the U.S. District Court for the District of Maine to vacate and remand the agency's prior rebate model.
CMS Extends Deadline for GENEROUS Model Application
On March 2, 2026, CMS announced an extension of the deadline for prescription drug manufacturers to apply to the GENErating cost Reductions for U.S. (GENEROUS) Medicaid Model from March 31 to April 30, 2026. Participating manufacturers "will provide supplemental rebates to participating states for drugs included in the model to align Medicaid net prices with what certain other countries pay."
Other News
FDA Issues Guidance on Alternatives to Animal Testing in Drug Development
On December 2, 2025, FDA issued draft guidance outlining specific product types for which six-month, non-human primate toxicity testing can be eliminated or reduced. In lieu of animal testing, FDA is incorporating risk assessments that integrate human-relevant models, such as computational toxicology, organoid systems, and real-world human safety data, into regulatory decision-making. The agency reported that a typical nonclinical program with a monoclonal antibody could include more than 100 non-human primates at costs of approximately $50,000 per animal.
About three months later, on March 18, 2026, FDA issued a draft guidance document titled "General Considerations for the Use of New Approach Methodologies in Drug Development." The draft guidance is meant to help drug developers "improve predictive toxicology in humans and move away from reliance on animal testing" by describing validation principles for new approach methodologies.
Court Stays HHS Secretary's Appointments to Advisory Committee on Immunization Practices
On March 16, 2026, a federal judge ruled that HHS Secretary Roberty F. Kennedy, Jr., likely acted arbitrarily and capriciously in June 2025 by replacing the 17 previous members of the Advisory Committee on Immunization Practices with 13 hand-selected appointees. The ruling stayed the 13 appointments, invalidating the votes made by these advisors.
FDA Launches TEMPO Pilot for Digital Health Devices
On December 5, 2025, FDA announced the Technology-Enabled Meaningful Patient Outcomes ("TEMPO") for Digital Health Devices Pilot, a voluntary program to promote access to certain digital health devices while safeguarding patient safety. In collaboration with the CMS Innovation Center's ACCESS model, the pilot will evaluate a risk-based enforcement approach for devices intended for cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.
FDA Clarifies Guidance on Use of Real-World Evidence in Medical Device Reviews
On December 15, 2025, FDA announced new guidance stating it will real-world evidence without requiring that identifiable individual patient data be submitted in certain medical device marketing submissions, with the agency similarly intending to consider updating its guidance for drugs and biologics. The guidance also outlines that sponsors should conduct and submit an assessment of the data underlying the real-world evidence, examining the relevance and reliability of such data. This policy change opens the door to using de-identified databases of patient records, such as hospital systems databases, insurances claims databases, and electronic health record networks, that were previously limited under FDA policy requiring private, confidential information at the individual patient level.
Executive Order Aims to Increase Medical Marijuana and Cannabidiol Research
On December 18, 2025, President Trump signed an executive order directing the attorney general to complete the rulemaking process to reschedule marijuana from Schedule I to Schedule III of the Controlled Substances Act. The order also directs the assistant to the president and deputy chief of staff for Legislative, Political, and Public Affairs to work with Congress to update the statutory definition of hemp-derived cannabinoid products to allow access to appropriate full-spectrum cannabidiol products.
In accordance with this December 18 executive order, DOJ and the Drug Enforcement Administration announced on April 23, 2026, the issuance of an order immediately placing both FDA-approved products containing marijuana and marijuana products regulated by a state medical marijuana license in Schedule III of the Controlled Substances Act, as well as the initiation of an expedited administrative hearing process to consider the broader rescheduling of marijuana from Schedule I to Schedule III. The new hearing, beginning June 29, 2026, will provide a pathway to evaluate broader changes to marijuana's status under federal law.
FDA Issues RFI on New Contracting Approach With Venture Capital Firms
On December 19, 2025, FDA issued an RFI seeking input from venture capital firms on developing a new contracting approach that would create direct relationships with qualified venture capital firms, enabling companies within an approved firm's portfolio to compete for and receive task orders to support FDA activities, including research, technology deployment, and regulatory innovation. The RFI announcement notes that "many breakthrough technologies and innovative solutions relevant to [FDA's] public health mission … are being developed by firms within venture capital portfolios."
FDA Issues Guidance Updates for Digital Health and Wellness
On January 6, 2026, FDA updated its guidance documents on Clinical Decision Support ("CDS") software and general wellness products, and withdrew its guidance on the adoption of international principles for Software as a Medical Device: Clinical Evaluation. The agency again revised the CDS guidance on January 29, 2026. The updated CDS guidance provides that FDA will exercise enforcement discretion for software functions that produce only one clinically appropriate treatment option or recommendation, a change from prior guidance that required multiple options. The updated General Wellness guidance expands the scope of products considered general wellness products not subject to FDA oversight to include certain of those that use non-invasive sensing to estimate physiologic parameters, such as blood pressure, oxygen saturation, blood glucose, and heart rate variability, when intended solely for wellness uses.
FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation
On January 11, 2026, FDA shared information about its "more flexible approach to overseeing" chemistry, manufacturing, and control requirements for cell and gene therapies. The announcement aims to clarify regulatory flexibilities previously applied on a case-by-case basis to expedite product development.
FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials
On January 12, 2026, FDA published draft guidance titled "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products." The guidance is designed to facilitate the use of Bayesian statistical methodologies in clinical trials of drugs and biologics, helping drug developers make better use of available data, conduct more efficient clinical trials, and deliver safe and effective treatments to patients sooner.
FDA PreCheck Pilot Program Launches
On February 1, 2026, FDA began accepting applications to participate in the PreCheck Pilot Program, a program intended to strengthen the domestic pharmaceutical supply chain by making the review and inspection process more predictable for selected U.S.-based drug manufacturing facilities.
Rare Pediatric Disease Priority Review Voucher Program Extended
On February 3, 2026, the Consolidated Appropriations Act, 2026 (P.L. 119-75) became law and reauthorized the rare pediatric disease priority review voucher program through September 30, 2029. FDA explains that the goal of the program is to encourage the development of treatments for rare pediatric diseases. As such, the program permits FDA to grant a sponsor of a rare pediatric disease drug a voucher to obtain priority review of another product.
FDA Launches Re-Assessment of BHA
On February 10, 2026, HHS announced that FDA launched a reassessment of the chemical preservative butylated hydroxyanisole ("BHA"), commonly used in food products. FDA will assess "whether BHA is safe under its current conditions of use in food and as a food contact substance." FDA issued an RFI in connection with the assessment.
On February 23, 2026, FDA issued a draft guidance document titled "Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause." The draft guidance sets out a "plausible mechanism framework" for developers seeking approval of individualized therapies to use in "generat[ing] sufficient clinical safety and efficacy data," and FDA is accepting comments on the draft guidance through April 27, 2026.
FDA Issues 30 Warning Letters Related to GLP-1 Marketing
On March 3, 2026, FDA announced it had issued 30 warning letters to telehealth companies that it said made "false or misleading claims regarding compounded GLP-1 products offered on their websites." FDA identified violations related to "implying sameness with FDA-approved products" and "obscuring product sourcing" through branding with the telehealth company's name, "implying they are the compounder." Since September, FDA has focused on telehealth companies' use of direct-to-consumer pharmaceutical advertising.
FDA Issues Guidance Responding to FDA Form 483 Observations
On March 7, 2026, FDA issued a draft guidance document titled "Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection." FDA stated that the guidance is intended to assist drug manufacturers who respond to FDA upon receipt of FDA Form 483 Inspectional Observations following an inspection to assess conformity with current good manufacturing practices.
FDA Issues Guidance on Biosimilar Development
On March 9, 2026, FDA issued draft guidance that provides new and revised questions and answers on biosimilar development and the Biologics Price Competition and Innovation Act of 2009. The draft guidance provides information and recommendations intended to facilitate prospective applicants' "development of proposed biosimilar products and proposed interchangeable products."
FDA Launches New Platform for Adverse Event Reports
On March 11, 2026, FDA announced the FDA Adverse Event Monitoring System ("AEMS"), a unified platform for analyzing adverse event reports for all FDA-regulated products. AEMS will consolidate multiple FDA adverse event legacy systems, with some systems, such as the FDA Adverse Event Reporting System (FAERS), being replaced immediately, and others being replaced in May, such as the Manufacturer and User Facility Device Experience (MAUDE). FDA expects AEMS to have real-time adverse event reports for all FDA-regulated products by the end of May 2026.
