Congressional Proposal Would Expand US FDA Role In Clinical Trials Embedded In Routine Care
Rep. Jake Auchincloss, D-MA, said the goal is to finalize the proposal this fall after stakeholder feedback and attach the package to the next FDA user fee reauthorization bill.
Key Takeaways
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A bipartisan proposal led by Rep. Jake Auchincloss would place the FDA at the center of a federal effort to embed clinical trials into routine care through reusable point-of-care trial networks.
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The proposal would direct the FDA to modernize IRB oversight and research governance, as well as establish timelines for launching and scaling trial networks.
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Lawmakers also proposed codifying the FDA’s Rare Disease Innovation Hub to support rare disease guidance development, drug development and individualized treatment efforts.
A bipartisan congressional proposal would position the US Food and Drug Administration at the center of a federal effort to embed clinical trials into routine health care delivery with reusable “point-of-care” trial networks intended to accelerate drug development and reduce trial costs.
The bipartisan draft legislation, led by Rep. Jake Auchincloss, D-MA, would name the Center for Drug Evaluation and Research’s Center for Clinical Trial Innovation the centralized coordinating entity within the Health and Human Services Department to establish reusable point-of-care clinical trial platform networks.
“I think the theory behind that is clinical trial modernization,” Auchincloss told the PinkSheet. “It doesn’t happen within one agency or within any one institution.”
“It is academic medical centers, it is clinical trial organizations,” he added. “It is CMS and their reimbursement policy. It’s NIH and their own clinical trial mechanisms, and then, of course, it’s FDA. And so the idea was like, who can be a quarterback of this? And this is our approach.”
The proposal would establish a one-year timeline to identify initial networks for participation and a three-year timeline for broader adoption, while directing the FDA to modernize institutional review board (IRB) oversight, ethical research standards, governance structures and the use of new technologies to support scalable trial platforms.
Auchincloss plans to solicit stakeholder feedback by July 1, release a final version of the proposal in the fall and attach the package as a policy rider to the next FDA user fee reauthorization bill.
FDA To Coordinate Point-Of-Care Trial Networks
Under the “Cures in Care Initiative” proposal, the FDA would coordinate with other agencies to align regulatory requirements for real-world clinical research data with Centers for Medicare and Medicaid Services and the Office of the National Coordinator for Health Information Technology interoperability standards. The FDA also would revise guidance addressing cross-agency data modernization and the use of digital and AI tools in point-of-care clinical trials.
Auchincloss said the proposal recognizes that much of the US health care delivery system where trials could occur operates outside the public sector and will require stronger public-privatecoordination.
“The idea is, if you’re trying to embed clinical trials in the point of care, then a lot of the point of care is just not public sector,” he said. “And so we’re going to need more collaboration.”
Auchincloss said the cystic fibrosis clinical research model is an example of embedded trial systems working across disease areas.
“They set up their own clinical trials infrastructure where at the point of care for cystic fibrosis, people were being enrolled in the clinical trials,” he said. “And it was a public, private set of partnerships that was very successful.”
The draft legislation also calls for identifying best practices and technical support programs to help health care organizations with limited infrastructure participate in reusable clinical trial platforms.
IRB, Phase I Trial Modernization
The legislation also would modernize preclinical and early-stage clinical development, including institutional review board oversight and Phase I trial regulation.
The FDA would establish pilot programs for third-party oversight of lower-risk Phase I studies modeled after Australia’s Clinical Trial Notification framework, as well as develop guidance for pre-certification of third-party organizations implementing the pathway.
The proposal also would require additional FDA guidance and pilot programs for oversight of IRBs and other organizations involved in early-stage studies.
Auchincloss said current IRB structures at academic medical centers have created layered and duplicative review processes that slow clinical development.
“Each individual academic medical center has become their own mini FDA, in some ways, for these trial sites,” he said. “And so you’re dealing both with the centralized FDA bureaucracy and the minibureaucracy at the academic medical center, and it’s not in parallel, it’s sequential.”
Former FDA Commissioner Martin Makary said prior to his May 12 resignation that he was preparing to announce a sweeping set of reforms to streamline investigational new drug applications, first-in-human Phase I studies and institutional review board processes.
The FDA also requested that Congress create an expedited investigational new drug application pathway for certain Phase I trials in its fiscal year 2027 budget request. Applications supported by preclinical data capable of satisfying regulatory requirements through validated new approach methodologies would qualify for the pathway.
In addition, the proposal would codify the FDA’s Rare Disease Innovation Hub and establish specific duties and funding mechanisms intended to support additional guidance, rare disease therapeutic studies and efforts to advance individualized therapies.
NIH, ARPA-H Would Lead Pilot Platforms
The legislation would direct Advanced Research Projects Agency for Health and the National Institutes of Health to implement at least three lead point-of-care clinical trial platform opportunities focused on rare diseases, high-burden chronic diseases and other significant unmet medical needs.
The proposal would establish criteria emphasizing participation by non-academic health care providers and those serving high-risk patient populations, as well as biopharma product developers.
The legislation also would provide funding for pilot platform awards and federal technical assistance to enable regulatory reforms, including support for NIH, ARPA-H and potential user fee-funded activities.
China Trial Debate Could Become Flashpoint
The proposal would direct the FDA to advance global regulatory alignment initiatives tied to clinical development modernization and strengthen oversight of foreign trials through inspection authorities and data quality verification requirements.
The legislation also would establish requirements for clinical data to be collected in the US, with exceptions allowed based on good clinical practice compliance and applicability to the US healthcare system.
“My sense is that there’s a broad bipartisan alignment on both sides of Pennsylvania Avenue [on] the need for America to do clinical trials that are faster, cheaper,” Auchincloss said. “I think the points of tension are going to be around what role do Chinese clinical trials play in American drug development.”
While the US historically has led global drug discovery, China has rapidly evolved from a hub for generic manufacturing into a major source of biopharmaceutical innovation. Chinese companies increasingly are licensing advanced drug candidates to multinational pharmaceutical firms.
China also now conducts more clinical trials annually than the US, particularly in oncology, and has become known for faster and lower-cost early-stage drug development.
Jiangsu Hengrui Pharmaceuticals and Bristol Myers Squibb have entered a broad cooperative R&D alliance covering 13 preclinical programs with a potential value of up to $15.2bn across oncology, hematology and immunology.
At the Axios Future of Health summit on May 13, BMS CEO Christopher Boerner said the deal reflects the pharmaceutical industry’s broader strategy of sourcing innovation globally and the growing competitiveness of China’s drug development ecosystem, particularly in early-stage research and development.
Boerner said China has become “particularly good and fast” at developing new medicines in the early stages of development, allowing companies to access innovative science and potentially bring those therapies to global markets faster.
Boerner also suggested the rapid pace of Chinese drug development should be a “call to action” for the US regulatory system. He argued that while the US remains the world’s leading biopharmaceutical ecosystem, maintaining that position will require an FDA that can keep pace with global innovation and ideally continue setting the standard for drug development and regulation.
By: Maaisha Osman
Source: Pink Sheet