Latest Action · Dec 1, 2025
Motion to reconsider laid on the table Agreed to without objection.
Bill Progress
Congress fast-tracks kids’ cancer trials as drug wars rage on
Why it matters
The bill would push more cutting-edge cancer drugs into pediatric trials, potentially replacing outdated chemotherapies for kids even as broader drug pricing and policy fights remain gridlocked.
H.R. 1262 glides through the House with a message no one wants to oppose: make drugmakers test promising cancer drugs in kids when the science points to benefit. The measure would tighten and extend molecularly targeted pediatric cancer trial mandates that Congress first put in place in 2017, forcing more adult oncology drugs into pediatric studies instead of leaving children to rely on outdated chemotherapies. The bill’s sponsors, led by Rep. Michael McCaul and a battalion of co-sponsors from both parties, frame it as a narrow fix to close loopholes and give families faster access to cutting‑edge treatments.
The broad backing is real. H.R. 1262 passed the House with overwhelming support alongside a reauthorization of pediatric priority review vouchers and other kid‑focused measures, drawing cheers from childhood cancer advocates who have pressed for stronger trial obligations. Republicans like Georgia pharmacist‑lawmaker Buddy Carter tout it as part of a broader push to spur research and development without heavy‑handed price controls, while Democrats see it as proof Congress can still use FDA authority to push industry when children are at stake. Pediatric groups, including national coalitions that track childhood cancer legislation, have lined up behind the bill as low‑friction, high‑impact policy.
But the same coalition that can agree on H.R. 1262 can’t agree on much else in drug policy. Even as the House advanced this bill to bolster childhood cancer drug development, fights over Medicare drug price negotiations, patent reform and FDA’s broader power to demand post‑market studies are deadlocked. Republicans who champion expanded pediatric obligations largely reject new federal leverage over prices or profits; Democrats who celebrate these child‑focused mandates still want sweeping changes to how the government pays for drugs and how quickly generics can challenge monopolies. H.R. 1262 becomes a political Rorschach test: proof to some that targeted, science‑driven regulation can move, and to others that Congress prefers popular, emotionally resonant fixes to confronting drug costs head‑on.
Visual Summary
HR1262 at a Glance
<div style="max-width:100%;">
<img src="https://legisletter.org/images/bill-infographics/hr1262-give-kids-chance-act.jpeg" alt="HR1262 Visual Summary - Give Kids a Chance Act of 2025" style="max-width:100%;height:auto;display:block;" />
<p style="margin:8px 0 0;font-size:14px;color:#555;text-align:center;">
<a href="https://legisletter.org/bill/hr1262-give-kids-chance-act" target="_blank" rel="noopener noreferrer" style="color:inherit;text-decoration:underline;">HR1262 Visual Summary – Give Kids a Chance Act of 2025</a>
<span> via </span>
<a href="https://legisletter.org" target="_blank" rel="noopener noreferrer" style="color:inherit;text-decoration:none;font-weight:500;">legisletter.org</a>
</p>
</div>What This Bill Does
Updates drug law for kids’ targeted cancer treatments
The bill changes the Federal Food, Drug, and Cosmetic Act specifically for “molecularly targeted” cancer drugs for children. In plain terms, it tweaks the rules that drug makers must follow when they test and approve cancer medicines that are designed to hit very specific changes in cancer cells in kids.
Requires special pediatric cancer investigations
Drug companies would have to do extra, kid-focused studies when they develop these highly targeted cancer drugs. Instead of assuming that adult cancer data is enough, they must actually look at how the drug works, and how safe it is, for children with cancer.
Ties pediatric studies to how a drug works, not just the cancer’s location
The bill focuses on “molecularly targeted” treatments, which are drugs built to go after a specific mutation or pathway in cancer cells. That means if a drug goes after a target that also appears in childhood cancers, the company can be pushed to study it in kids, even if the original adult cancer it was made for is totally different.
Uses FDA authority to enforce these pediatric study rules
Because it amends the main federal drug law, this bill gives the Food and Drug Administration the legal backing to demand these child-focused cancer studies as part of the normal drug approval process. In practice, that’s like the FDA saying, “If you want approval for this kind of cancer drug, you also need to address how it will be studied in children.”
Aims to speed up access to modern cancer drugs for kids
By hard-wiring pediatric investigations into the law for targeted cancer drugs, the bill tries to close the gap where adults get new treatments years before children do. It pushes companies to think about kids earlier, instead of treating pediatric trials as an optional extra.
Who Benefits
Children with cancer and their families
They stand to get access to newer, more precise cancer drugs sooner, instead of waiting years after adults. It also means the treatments given to kids are tested more carefully for their bodies, not just based on adult data.
Pediatric oncologists (children’s cancer doctors)
They get more and better data about how new targeted drugs work in children, which helps them make safer, smarter treatment decisions. It also expands the toolbox of modern medicines they can offer to young patients.
Researchers working on childhood cancer
They gain more required studies and clinical trials focused on kids, which can generate data, samples, and insights that are often hard to get. That can speed up discoveries and improve future treatments.
Hospitals and cancer centers that treat children
They are more likely to be involved in pediatric trials for new targeted drugs. That can improve care options for their patients and strengthen their role in leading-edge cancer research.
Who's Affected
Pharmaceutical and biotech companies developing targeted cancer drugs
They face new or strengthened requirements to plan and run pediatric cancer studies when their drug hits targets found in childhood cancers. This can change their development timelines, trial designs, and budgets, because they can’t just focus on adult patients and ignore kids.
Regulators at the Food and Drug Administration (FDA)
They must review more pediatric study plans and results as part of cancer drug approvals. Day-to-day, that means more work evaluating whether companies are doing enough to test these drugs in children and enforcing the new rules.
Clinical trial sites and staff running pediatric cancer studies
They may see an increase in the number and complexity of trials for targeted cancer drugs in kids. That affects how they schedule staff, recruit patients, and manage the ethics and logistics of testing new treatments in children.
Parents of children with cancer
They may be offered enrollment in more clinical trials for new targeted drugs for their kids. This creates more choices—but also more decisions to make about risks, benefits, and whether to try an experimental treatment.
Cosponsors (313)
Gus Bilirakis
Republican · FL
Debbie Dingell
Democrat · MI
Kim Schrier
Democrat · WA
Diana Harshbarger
Republican · TN
Doris Matsui
Democrat · CA
Dan Crenshaw
Republican · TX
Kathy Castor
Democrat · FL
Mike Kelly
Republican · PA
Lori Trahan
Democrat · MA
Randy Weber
Republican · TX
Robert Wittman
Republican · VA
Rick Allen
Republican · GA
Recent Actions
Motion to reconsider laid on the table Agreed to without objection.
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4929-4932)
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4929-4932)
DEBATE - The House proceeded with forty minutes of debate on H.R. 1262.
Considered under suspension of the rules. (consideration: CR H4929-4935)
Mr. Carter (GA) moved to suspend the rules and pass the bill, as amended.
Placed on the Union Calendar, Calendar No. 304.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-352.
What Changes in the Law
1 changes
Sections Amended
Section 505 of such Act (21 U.S.C. 355) or licensed under section 351 of the Public Health Service Act (42 U.S.C. 262). SEC. 7. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. Section 409I(d)(1) of the Public Health Service Act (42 U.S.C. 284m(d)(1))
striking ``section,'' and all that follows through the period at the end and inserting ``section, $25,000,000 for each of fiscal years 2026 through 2028
Committees (1)
Contact Your Representatives
Find your legislators and make your voice heard on Give Kids a Chance Act of 2025.
Find Your LegislatorsFor Advocacy Organizations
Launch grassroots campaigns that mobilize supporters and move legislators to action.
Get a DemoNews Coverage
2 articles about this bill
Full Bill Text
Open in New TabSource: Congress.gov
