ACRO’s 2025 Clinical Research Regulatory and Legislative Wrap-up

Written by:
Karen Noonan, Senior Vice President, Global Regulatory Policy at ACRO
Sophia McLeod, Advocacy Advisor at ACRO
Fiona Lewis, Advocacy Associate at ACRO

2025 brought unprecedented turbulence to the clinical research ecosystem in the U.S., with changes to HHS, FDA, and Congress, as well as in the EU and UK, fundamentally shifting how these bodies interact with the clinical research industry.

Through reductions in force (RIFs), a government shutdown, regulatory adjustments, leadership transitions, and beyond, ACRO has meticulously monitored and responded to these changes to help bolster the standards of clinical research domestically, and globally.

In 2025, the FDA experienced significant leadership transitions and marked changes in policy priorities.

• In January, the FDA removed its draft guidance for the use of Diversity Action Plans from its website. 
• On March 25, Dr. Martin Makary, MD, MPH, became the 27th Commissioner of the FDA. Following Commissioner Makary’s confirmation and the resignation of Peter Marks, Dr. Vinay Prasad, MD, MPH was tapped as CBER Director in May. Most recently, Dr. Tracy Beth Hoeg, MD, PhD was named Acting Director of CDER following the departures of Dr. George Tidmarsh, MD, PhD, and Dr. Richard Pazdur, MD. 
• Reductions in force in April left 3,500 staffers terminated. 
• Commissioner Makary launched his Commissioner’s National Priority Voucher Program in late October. 
• On October 1, the federal government shut down following a lapse in federal appropriations. ACRO thoroughly tracked the shutdown to determine impact on our members, considering the actions that FDA could continue to take using funds from its User Fee programs, and which programs and activities ceased immediately upon the shutdown. 
• Fall 2025 marked new announcements of FDA’s policy priorities for the life sciences industry. In November alone, Commissioner Makary and Director Prasad published an article in the New England Journal of Medicine detailing the FDA’s Plausible Mechanism Pathway and Director Prasad released a memo questioning vaccine evidence in which he called for larger RCTs and the need for evidence of disease reduction in vaccine trials. In December, Commissioner Makary announced a new standard of one pivotal trial. 

2025 marked the beginning of the 119^th Congress with legislation and evolving policy interests that would impact our industry. These interests can be divided into two categories – expanding clinical trial access and how technology can aid in that effort and bolstering the U.S.’ position as a global leader in biomedical research. 

Congressional interest in how to expand clinical trial access and utilize technology to do this has focused on the following avenues: 

• Cost of Clinical Trials.
  • Conversations on Capitol Hill surrounding drug pricing often led to further conversations with stakeholders about the cost of drug development. Specifically, in relation to ACRO’s work, Members of Congress have questioned why clinical trials are the most expensive portion of the drug development cycle and endeavor to understand more about why this might be the case. Furthermore, Members have inquired how costs can be cut during the clinical trial period to then reduce drug prices altogether – this often led to discussion around the use of AI/ML in clinical research and the movement of clinical trials to other countries, such as China.  
• Use of AI/ML to improve clinical trial efficiency and reduce costs.
  • AI has become an exceedingly bipartisan topic. Members have displayed a great deal of curiosity around how ACRO members are using AI when designing and running clinical trials, how AI impacts the life sciences industry (cost savings, increased efficiency, etc….), and what is the congressional role in regulating AI. 
•  Access to clinical trials and representation amongst participants.
  • Members of Congress have expressed interest in understanding how ACRO views barriers to clinical trial participation. This includes physical/location barriers to participating in clinical trials (such as impacts on rural constituent access to trial opportunities), financial barriers to participation (legislation was introduced in the House in 2025 aiming to address this issue), as well as concerns over cuts to federal agencies, such as the National Institutes of Health, impacting federally funded trials. 
• FDA performance/relationships with stakeholders.
  • Changes at the FDA in 2025 presented unique challenges to both our industry and Congress. Members of Congress have often inquired what ACRO and our members have experienced when working with this FDA (changes in review times, increased or decreased communication with the agency, etc.), what impact the government shutdown had on the FDA and on ACRO members downstream, and finally, how ACRO members were (or will be) impacted by FDA RIFs, funding fluctuations at FDA and NIH, and recent legislation or executive actions, like the One Big Beautiful Bill and changes to the H-1B Visa program. 
• Biotechnology innovation and leadership. 
  • Congressional interest in biotechnology strengthened in 2025, as well, with a focus on bolstering the United States’ position as a global leader in the biotechnology and biomedical research industries. Interest in growing the United States’ presence in the biotechnology industry has become more prominent as concerns grow with Chinese leadership in biomedical research. There were various congressional actions taken on this matter in 2025, including the release of the National Security Commission on Emerging Biotechnology report, which included insight into China’s biotechnology initiatives and recommendations for the U.S. to gain leadership in this area, as well as National Defense Authorization Act, which highlighted support for research and development for bio-industrial manufacturing  and set forth requirements for the Department of Defense’s Biotechnology Strategy. 

2025 provided the opportunity for ACRO to help shape regulatory oversight of clinical trials worldwide. Regulatory activities impacting clinical research can be grouped into three categories – AI/ML in drug development, clinical trial assessment timelines, and enabling use of EHRs in clinical trials. 

• 2025 was an opportunity for ACRO to help shape the regulatory oversight of AI/ML in drug development. 
  • In the U.S., the FDA’s issuance of draft guidance on Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products in April had a positive impact on the deployment of AI tools by ACRO members. In addition to urging the expeditious finalization of the draft guidance, ACRO’s comment to FDA applauded the Agency’s risk-based, flexible, and pragmatic approach to AI oversight and recommended the inclusion of illustrative case examples in the final guidance. ACRO had an opportunity to provide further input to FDA during its May listening session with the Agency.  Moreover, the AI listening session enabled ACRO to fortify ties to CDER/center experts during a time of overall leadership volatility and change. 
  • In the EU, the Chair of ACRO’s AI Committee was able to press for FDA’s approach to be a model for EMA to adopt a similar risk-based, flexible, and pragmatic approach to AI oversight during ACRO’s first-ever Bilateral Meeting with EMA Leadership in September.  Most importantly, the EMA Bilateral Meeting established ACRO as a stakeholder akin to the sponsor association of EFPIA. Also in September, the EMA established a new industry stakeholder advisory group on AI, and ACRO successfully pressed for a standing ACRO seat and industry voice on this new body. 
  • ACRO had yet another opportunity to shape AI policy and press for a risk-based, flexible, and pragmatic approach to AI oversight in its response to the ICH consultation on M15: General Principles for Model-Informed Drug Development 

• 2025 was an opportunity for ACRO to press for improved timelines for the assessment of trial applications. 
  • In the UK, ACRO continued its quarterly survey of member experience with UK trial assessment timelines.  ACRO concerns and survey results were shared with MHRA leadership during in person meetings in Washington DC in June and London in September.  MHRA thanked ACRO for these data, which we will continue to collect and share with the Agency, as initial applications are trending in the right direction but still far from 100 percent compliance with statutory timelines. 
  • In the EU, there were multiple opportunities to press for shorter assessment timelines, in addition to other ACRO recommendations for streamlining the clinical trial environment in the EU.  The EU Biotech Act was a propitious opportunity for ACRO to present a targeted list of recommendations through various public consultations and surveys throughout the year, which culminating in two key ACRO meetings where we pressed our concerns directly:  (1) a Bilateral Meeting with EMA leadership in September and (2) a listening session with DG Sante of the European Commission in November.  

• 2025 allowed ACRO to continue its campaign to remove barriers to the use of EHRs in trials that are created by the EMA Guideline on computerised systems and electronic data in clinical trials.
  • ACRO won a speaking role at the November meeting of the EMA GCP Inspectors Working Group to outline our recommendations to resolve barriers to EHR use created by the computerized systems guideline, and we will be identifying any remaining next steps for early 2026.