Auchincloss bill seeks to improve ‘operating system for science’
For more than a decade, it has been clear that U.S. clinical trials are too slow, too costly, and too far removed from the places where patients get care. It has taken the success of competitors, especially in China, and the outflow of Phase I trials to Australia, to move policymakers toward action.
Fear of falling behind has created a nonpartisan constituency for modernizing clinical trials infrastructure. The need to reauthorize FDA user fees by Oct. 1, 2027 has provided a vehicle and a deadline.
Rep. Jake Auchincloss (D-Mass.) wants to take advantage of the opportunity. His Faster Clinical Trials Act borrows from Australia’s playbook for early-stage trials and raises the bar for clinical data generated abroad.
It goes much further, aiming to strengthen the infrastructure that supports biomedical research. “This is a science infrastructure bill,” Auchincloss told BioCentury. “It's really about making the operating system for science more productive.”
The core idea is to embed research in routine care, laying the foundation for a learning health system. The bill spans the development cycle, from investing in a large-scale biobank that could fuel discovery to streamlining first-in-human trial launches to removing obstacles that have limited the uptake of biosimilars.
In an interview with BioCentury, Auchincloss acknowledged that he has “much more wood to chop” to move the bill onto President Donald Trump’s desk, and expressed confidence that it will avoid the partisan fights that have turned Congress into a place where good ideas go to die.
Auchincloss plans to reintroduce the legislation in 2027 and hold a hearing that would lay the groundwork for incorporating the bill into legislation that will accompany FDA user fee reauthorization. He has a House co-sponsor, Rep. Morgan Griffith (R-Va.), and has lined up bipartisan Senate sponsors, who he declined to identify.
“If you look at all the issues that we grapple with within the biomedical development policy space — drug pricing, basic research funding, vaccines, most favored nation, 340B — of all the issues, I would argue this is the one that is most timely and primed for a bipartisan legislative solution,” Auchincloss said.
The bill was developed with support from the Duke-Margolis Institute for Health Policy and input from biopharma companies, investors, FDA, patient advocates and academics. Auchincloss wants to attach it to user fee reauthorization, but its most ambitious elements would depend on appropriations.
While he may be right about the bipartisan support for science infrastructure, he could face resistance from members of Congress who are skeptical of his contention that the cost, at least $7.8 billion over five years, would be outweighed by benefits to the economy.
Some funding authorizations are loosely defined and could change as the bill advances. For example, the bill would authorize $500 million annually — $2.5 billion over five years — for FDA to address the root causes of clinical holds, expand meetings with sponsors, and speed the public release of complete response letters (CRLs), without specifying how funding would be allocated among those activities or why that amount is needed.
“The return on investment for the United States on having the world's gold-standard biomedical regulator is measured in the hundreds of billions of dollars,” Auchincloss told BioCentury.
Integrating research into routine care
The animating idea behind the legislation is that “routine point-of-care clinical trials” should become a standard way to generate evidence about the safety and efficacy of medical interventions. Studies of medical products would be built into ordinary clinical practice, with treating clinicians serving as investigators during regular in-person or virtual visits.
Second-order impacts, beyond accelerating the pace of drug development, could be substantial.
Reviving the tradition of the physician-scientist could bring in new ideas, and expanding the number of patients who participate in and benefit from research could build a broad constituency for policies that support biomedical innovation.
Trials could run in primary care offices, outpatient clinics, and patients’ homes. Auchincloss envisions consumer-facing organizations like Walmart recruiting healthy volunteers for Phase I trials.
Protocols would be pared back to the essentials, with as much data as possible extracted from EHRs.
To make point-of-care trials routine, the bill would create a Cures in Care Initiative, with a new Center for Clinical Trial Innovation at FDA’s Center for Drug Evaluation and Research.
The initiative would have a year to select priority diseases or biological mechanisms and stand up at least three “lead networks,” building on existing trial networks. Each network would cover at least one high-burden chronic disease and one group of related rare diseases, use a decentralized hub-and spoke model, and rely on a designated central IRB.
The networks are conceived as reusable platforms that would include studies from multiple sponsors over time.
FDA and NIH grants could pay for Phase II and III trials, label expansion studies, comparative effectiveness research, and postmarketing commitments. Networks would have to partner with commercial developers, include emerging biotechs, and show how they would keep operating after federal funding ends.
To expand access to clinical research beyond the areas served by academic medical centers, grants would go only to networks that prioritize “less-resourced” settings such as rural health clinics, critical access hospitals, safety-net hospitals, and Indian Health Service and Tribal facilities.
The bill would also lower barriers at well-resourced academic medical centers. It would make single-IRB review mandatory for most multi-site FDA-regulated trials, support electronic consent, and create an FDA-endorsed site certification program. FDA would be required to issue guidance on network governance and on adaptive, Bayesian, platform, decentralized, and external-control designs, and update its guidance on decentralized trials and real-world evidence.
The bill seeks to create data infrastructure to support the use of EHRs and distributed trials, including standards and guidance on the integration of telehealth, wearables, and digital health tools into clinical research.
One of the most impactful pieces of the bill attempts to sweep away financial hurdles to integrating clinical research into routine care. It would require CMS to clarify that Medicare covers routine care costs for beneficiaries in point-of-care trials, including care delivered remotely or through digital tools, and explain how evidence from those trials can inform national coverage determinations.
Within three years, the Cures in Care Initiative must adopt a plan for expanding point-of-care trials beyond the first networks. The plan must include “stretch goals” and timelines for reaching them.
On access, the aim is for point-of-care trials to be offered at 60% of the places where patients get care and to reach 90% of patients eligible for a network trial.
On cost and speed, the plan is to approach a 30% to 50% reduction in the cost of enrolling each patient and a 30% reduction in the time it takes to complete trial enrollment. On results, the goal is that 90% of participants are in trials that finish and produce findings that are independently reviewed and made public.
Borrowing from Australia, taking other measures to speed trial starts
The faster trials bill instructs HHS to establish an expedited procedure for reviewing and starting lower-risk Phase I trials, using guidance and a pilot. In designing the pilot, HHS must study foreign fast-track systems and incorporate what it finds.
The intention, Auchincloss told BioCentury, is to create a system in the United States that emulates Australia’s Clinical Trial Notification scheme, while “respecting the fact that America is not Australia.”
The bill defines lower-risk Phase I studies as those that present minimal potential for harm, test subtherapeutic or non-toxic doses with no therapeutic intent, or studies initiated by an investigator.
Under the bill, FDA would launch a pilot project to allow qualified third parties to review lower-risk Phase I trials. To qualify, a reviewer must be an IRB, or another entity HHS designates, that has the technical competence to review toxicology data and to judge CMC/GMP compliance at a level comparable to FDA's IND review. Accreditation criteria are modeled on FDA's existing third-party reviewer program for devices.
The bill requires HHS to study the feasibility of adding higher risk studies to the expedited Phase I review scheme. The bill addresses complaints from investigators and small biotechs that CGMP regulations create unnecessary barriers to launching FIH trials. It gives FDA one year to propose revisions to regulations on CMC compliance.
The bill also seeks to reduce clinical holds, a persistent cause of delayed trial launches. It directs FDA to address the root causes of clinical holds, starting with identifying common causes of holds and delays, especially for first-time sponsors and investigator-initiated trials. FDA would develop best practices for preparing and reviewing INDs, hold more in person meetings in place of written responses, engage sponsors earlier to agree on trial designs, and designate a contact for emerging biotechs.
The bill also wades into the debate over FDA’s release of CRLs, including for unapproved products. It would direct FDA to clarify what information can and must be redacted from CRLs, develop redaction tools including AI-based tools, speed public release of the letters and pilot ways to expand access. It would not give FDA the explicit statutory authority to release CRLs for unapproved products that former FDA Commissioner Marty Makary sought from Congress, leaving the policy exposed to a legal challenge already pending at the agency.
Investing in a bigger biobank
All of Us, an NIH initiative that aims to collect longitudinal data on at least one million people living in the United States, is withering on the budgetary vine. It has lost about three quarters of its funding since 2023, forcing NIH to scale back its ambition.
Auchincloss aims to revive and expand it with annual investments of $500 million, about the funding level for All of Us in 2023. While it may take 10 or 20 years to harvest the fruit, he told BioCentury it may be “the most important thing that happens” if the faster trials bill is enacted.
The idea is to incorporate All of Us and data from the Department of Veterans Affairs’ Million Veteran Program into an American Frontier Biobank that has a goal of collecting samples from at least 3% of the U.S. population, roughly 10 million people.
Specimens would be turned into multi-omic data and linked to EHRs, participant-reported information and environmental exposures. Data would be collected over time, with repeat sampling and continuous health data integration.
One of the goals is to recruit biobank participants into clinical trials, which could speed enrollment in biomarker-defined and rare disease studies.
A “high-five from Congress” for OCE, biosimilars reforms
The Oncology Center of Excellence (OCE) was created in 2017 under a provision of the 21st Century Cures Act requiring FDA to establish at least one intercenter institute for a major disease area. The law doesn’t mention oncology. The bill would write the OCE into statute, ensuring that it endures.
The bill codifies several of the projects OCE created under its first director, Richard Pazdur. Initiatives that would be made permanent include: Project Orbis, which supports concurrent international reviews; Project Optimus, OCE’s push for dose optimization; Real-Time Oncology Review; Project Confirm, which tracks accelerated approval commitments; Project Pragmatica, which promotes pragmatic trials of approved products; and Project Renewal, an effort to keep oncology drug labels up to date.
The intention, Auchincloss told BioCentury, is to “lift up what has been a success story at the FDA and to allow it to be templated to other modalities or disease groups.” He described the OCE provisions as a “high-five from Congress” to OCE.
The bill would reduce impediments to biosimilar competition by deeming every licensed biosimilar interchangeable with its reference product.
This would allow pharmacy-level substitution in states that require that designation. It would also put into law FDA's recent move away from requiring switching studies and narrow biosimilar developers' pediatric study obligations, while leaving the standard for demonstrating biosimilarity unchanged.
Bolstering rare disease drug development
The bill seeks to solidify and expand the Rare Disease Innovation Hub, which was created during the Biden administration to coordinate rare disease product review activities across FDA.
The hub would become a statutory intercenter institute. This would ensure that it is not eliminated by future administrations.
The bill would direct $30 million a year to the hub for FY2027–31: $5 million from FDA and $25 million transferred from NIH and ARPA-H.
It gives the hub roles in addressing some of the most persistent complaints from rare disease drug developers. The hub would serve as a “point of escalation” for sponsors seeking re-review or consultation on review decisions. It would also give review teams technical assistance to improve consistency and to document agreements on acceptable trial designs.
In addition, the hub would fund efforts to help academic investigators and patient organizations access manufacturing capacity, including at federal labs. It would also support a national network of rare disease clinical centers of excellence.
Say ‘China’ without saying China
The bill does not specifically target China, but it would raise the bar for using foreign clinical data, particularly data from trial sites or contractors that meet the criteria for “biotechnology companies of concern.” Under the BioSecure Act, the biotechnology companies of concern designation is aimed largely at Chinese life sciences companies.
When FDA inspects a site running a trial meant to support an NDA or BLA, it would have to require the site to certify compliance with international good clinical practice standards.
Before accepting data from any trial site, contract research organization, or data vendor that meets the criteria for a biotechnology company of concern, FDA would have to verify, on-site or remotely, that the trial met those standards and data security protocols.
For Phase I and II trials conducted outside the U.S., FDA could require sponsors or investigators to submit source data and audit trails for each primary and secondary endpoint, English translations of informed consent records, and chain-of custody records for biological samples and test articles.
FDA could refuse to accept the data if the documentation isn’t provided.
The bill would require that pivotal trials supporting NDAs and original BLAs include some patients at U.S. sites; it does not specify minimum levels of U.S. enrollment.
It lists circumstances FDA can consider if marketing applications are not supported by pivotal trials with U.S. participants, including rare diseases, foreign data FDA finds applicable to U.S. patients and can validate, unavailable or impractical U.S. sites, and public health emergencies, though it doesn't clearly make them exceptions.
The goal of the foreign data provisions “is to treat that as global infrastructure, where we want the data to be interoperable, high-quality, trusted,” said Auchincloss.
By: Steve Usdin
Source: BioCentury