Auchincloss: Clinical Trial Reform Could ‘Catch A Ride’ On Next PDUFA Package
Rep. Jake Auchincloss (D-MA) is eying the next Prescription Drug User Fee Act (PDUFA) reauthorization, expected early next year, as a vehicle for a bipartisan clinical trial reform package aimed at making the U.S. clinical development system faster, cheaper, more data-driven and more integrated into routine health care.
Auchincloss previewed the strategy Wednesday (May 13) during the Duke-Margolis 2026 Health Policy Conference, telling stakeholders he wants to begin building support for the bill now so it can be ready to move when Congress takes up the next PDUFA package
“We want to then release final legislative text, mark it up, demonstrate committee support this year and that way when we're negotiating PDUFA next year, it can catch a ride,” he said during a fireside chat. “One thing I had learned, been here for six years now, is you got to pack your bags before the train comes.”
Auchincloss added that while he sees limited overlap between Republicans and Democrats on most health care issues, clinical trial reform is one area where he believes there is bipartisan support to address rising development costs, slow trial timelines, limited patient access and growing concerns that the United States is losing ground to countries with faster early-stage research systems, such as China.
“If you're trying to get stuff done in this incredibly, incredibly partisan environment where there's so many fundamental disputes about health care -- better, faster, cheaper, clinical trials is a good common ground,” he said. “I mean, that is a quadruple win across the board, patients, industry, economic competitiveness, and in our health care infrastructure itself.”
According to a draft legislative summary released by the congressman’s office at the event, the proposal would create a Cures in Care Initiative, building on the 2016 21st Century Cures Act’s goal of accelerating medical product development. The initiative would be aimed at making clinical trials easier to run through routine health care settings, rather than relying primarily on traditional academic trial sites.
The proposal would designate the Center for Drug Evaluation and Research’s Center for Clinical Trial Innovation Hub as the lead HHS entity for coordinating the initiative, including by working with other federal agencies, health systems and research partners to develop point-of-care trial networks that can be used across multiple studies.
It also would push FDA to create clearer rules for when drug developers can use lab-based models, computer simulations, and other alternatives to animal testing in early phase clinical trials. And the proposal would encourage companies and research groups to share information on how to prove those tools are reliable, with the goal of helping FDA expand their use in drug development, including for rare diseases.
One of the more significant changes would be a pilot for third-party oversight of certain lower-risk Phase 1 trials, modeled in part on Australia’s clinical trial notification system, which relies more heavily on ethics committee review and regulator notification than upfront agency review. According to the draft, the U.S. pilot would differ by having FDA define which studies qualify and by using qualified third parties to oversee those trials within an FDA-established framework
The draft also includes provisions to codify FDA’s Rare Disease Innovation Hub and support the development and validation of clinical outcome assessments for rare disease studies. In practice, that is meant to give FDA a more formal structure for coordinating rare disease work across centers, supporting individualized therapies and helping sponsors design trials in areas where small patient populations make traditional studies difficult.
The draft also would try to reduce trial delays by directing HHS and FDA to identify recurring areas of good clinical practice noncompliance and to encourage earlier meetings with sponsors to address those issues before they lead to clinical holds or other bottlenecks. Additionally, it would require the Government Accountability Office to review whether FDA is using its drug development resources efficiently and consistently, particularly for rare disease therapies.
The proposal would also encourage FDA to rely more on inspection reports from trusted foreign regulators that enforce comparable manufacturing standards, allowing the agency to focus its own inspections on higher-risk facilities. And it would direct FDA to improve the competitive generics pathway, while eliminating the separate legal designation for interchangeable biosimilars -- a change that could simplify the follow-on biologics market.
The proposal builds on a clinical trial modernization push that became a priority under former FDA Commissioner Marty Makary, who last month unveiled FDA’s first real-time clinical trials initiative to allow the agency to track safety issues and early signs of effectiveness before trial data are fully compiled and submitted through the traditional process.
Makary framed the initiative as part of a broader effort to reduce administrative burden, speed drug development and make the United States more competitive with countries that have faster early-phase trial systems.
But Auchincloss cautioned at the Duke Margolis event that it would be shortsighted to view artificial intelligence alone as the answer to the country’s clinical development challenges. While AI may help reduce administrative burdens and improve data analysis, he said, the physical bottlenecks in clinical trials -- including where studies are conducted, how patients are recruited and how quickly early-stage research can move -- will remain unless Congress and FDA create a broader framework for modernizing the system.
“The world of bits can get fast, but the world of atoms is going to be stubborn, and we got to ... widen that aperture to respond to the world of bits,” he said.
Auchincloss also tied the proposal to U.S. competition with China in biotechnology, arguing the goal should not be a wholesale retreat from Chinese clinical research, but a more durable international framework for clinical trial standards and drug development. He said the United States should push for greater harmonization of clinical trial expectations while also pressing China to pay more for innovative medicines, rather than benefiting from research and development costs largely borne by the United States.
He warned that a simplistic effort to pull clinical trials out of China could backfire if drugmakers shift products through European regulators while China continues expanding its role in global biomedical research. Instead, Auchincloss argued the United States needs a framework that treats biotechnology as a “defense-only” domain, making it safer to cooperate with China on clinical trial standards and cost-sharing while still protecting national security interests.
“[The Chinese] are free-riding on our R&D right now. And if we can start with that basis of trust, we can get them to pay more for new medicines and spread the cost of R&D across a much larger population and speed more cures to market,” he said.
By: James Jarvis
Source: InsideHealthPolicy