Rep. Auchincloss plans a bill to copy Australia's faster early-phase trial rules
Rep. Jake Auchincloss (D-Mass.) plans a bill modelled on Australia's faster early-phase clinical trial regime, he said at the STAT Summit. He wants the US to answer China's biotech rise by speeding domestic research.
The Scientist · Science desk
What happened
- Australia sped up its clinical trial regime in part by letting early-phase trials bypass pre-approval evaluation by the national regulator, STAT reported.
- Auchincloss conceded that early-stage trials in the US will never be as cheap as in China, but said they should be as fast.
- He named Russ Vought, the White House budget director, as a villain and said Vought considers science a "blue state subsidy."
Why it matters
- Who has to decide decision Members weighing China-focused biotech protections now have a speed-first alternative to consider, and its author says the protectionist route hurts US competitiveness.
- What it limits constraint With the cost gap conceded, time is the only variable the bill can move, and an early-phase carve-out reaches only the first stage of development.
- Who's exposed exposure Researchers on federal grants are exposed if the OMB proposal advances, since it would let the White House end grants at will and override peer reviewers.
The proposal comes in two sentences of reporting, so its design is open. STAT's report does not include bill text, and it does not say what review, if any, takes the place of the regulator's pre-approval evaluation in Australia's model [3].
The thing this doesn't tell you is whether start-up time is the delay a US sponsor actually hits. A faster start shortens the path to approval only if later phases do not absorb the time saved.
Auchincloss is arguing against a current. Protectionist policies against China are popular in Washington for industries like tech, STAT reported, and there is bipartisan support for extending them to biotech, where China is rapidly gaining on the US [5][15]. Speaking in Boston on Thursday [2], he said: "Washington needs to fix itself and worry less about what China is doing because China is going to be excellent." He added: "But we can be even better." [7] STAT wrote that this matches the views of the biotech industry and its investors [8].
He ties the case for speed to a complaint about how Washington makes decisions. He said the FDA's priority voucher program, created by former Commissioner Marty Makary, politicizes decisions that should be guided by transparent, well thought-out standards [13]. STAT's example was Makary awarding vouchers to psychedelics after podcaster Joe Rogan texted Trump about ibogaine research [14].
"If Washington behaves that way, there's nothing that we're going to do about Beijing that's going to save our biomedical leadership," Auchincloss said [11]. "Because ultimately, what makes us great is high, clear, transparent standards paired with the world's best talent getting funded to pursue curiosity-driven research." [12]
We'd expect the bill to be judged against that yardstick. A carve-out that lets early-phase trials bypass the regulator has to show how it fits "high, clear, transparent standards" [12].
What to watch
- Bill text when introduced: which review step, if any, replaces the regulator's pre-approval evaluation, and whether the carve-out stops at early-phase trials.
- Whether bipartisan support for extending China-focused protections to biotech turns into legislation that competes with a speed-first bill.
- Whether the OMB proposal to override peer reviewers and terminate grants at will advances.
Clarity's read
What the record supports and how the coverage leans. The claims behind it follow.
Reality
- Evidence35
- Adoption
- Not scored
- Hype gap+10
- Incentives50
- Confidence55
Claim ledger
Ranked by verification strength, evidence, and original report placement.
- [1]
Rep. Jake Auchincloss (D-Mass.) plans to introduce a bill that would adopt the approach taken by the Australian government to its clinical trial regime.
- [2]
Auchincloss spoke at the STAT Summit in Boston on Thursday, in conversation with STAT's Chelsea Cirruzzo.
- [3]
The Australian government has sped up its clinical trial regime in part by allowing early-phase trials to bypass pre-approval evaluation by the national regulator.
- [4]
Auchincloss said it will never be as cheap to conduct early-stage trials in the U.S. as it is in China, but it should be as fast.
- [5]
Protectionist policies against China in industries like tech are popular in Washington, and there is bipartisan support to extend those protections to the biotech sector.
- [6]
Auchincloss said that the protectionist approach hurts America's competitiveness.
- [7]
Auchincloss said at the STAT Summit: "Washington needs to fix itself and worry less about what China is doing because China is going to be excellent," and "But we can be even better."
- [8]
Auchincloss's attitude aligns with the views of the biotech industry and its investors, who hold that America cannot stop China from becoming a biotech powerhouse and Congress should invest in domestic biotech and speed research and development.
- [9]
Auchincloss named Russ Vought, director of the White House Office of Management and Budget, as a villain and said Vought considers science a "blue state subsidy."
- [10]
The OMB proposed empowering the White House to override the recommendations of peer reviewers, terminate grants at will, and exercise more latitude in the type of research federal agencies support.
- [11]
Auchincloss said: "If Washington behaves that way, there's nothing that we're going to do about Beijing that's going to save our biomedical leadership."
- [12]
Auchincloss said: "Because ultimately, what makes us great is high, clear, transparent standards paired with the world's best talent getting funded to pursue curiosity-driven research."
- [13]
Auchincloss took issue with the FDA's Commissioner's National Priority Voucher program, created by former FDA Commissioner Marty Makary, and said it politicizes decisions that should be guided by transparent, well thought-out standards.
- [14]
As an example of politicized voucher decisions, STAT wrote that Makary awarded vouchers to psychedelics after podcaster Joe Rogan texted Trump about research around ibogaine.
- [15]
China is rapidly gaining on the U.S. biotechnology industry.
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Sources
1 independent publisher whose own reporting we read for this story.
- statnews.comMass. lawmaker Auchincloss favors boosting U.S. biotech over targeting China
1 article · October 15, 2026
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