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Mikaela Naylon Give Kids a Chance Act
This legislation requires pharmaceutical companies developing certain adult cancer therapies to study those drugs in combination with other treatments for pediatric cancer. It extends the priority review voucher incentive for rare childhood disease treatments through September 2029 and limits orphan drug market exclusivity to specifically approved uses, allowing competitors to market drugs for other uses of the same disease. The bill also helps generic manufacturers match brand-name formulations more easily, modernizes electronic record sharing for the national organ transplant system, and adds over $1.2 billion to the Medicare Improvement Fund.
People affected—Not determinable from the text provided; the bill affects pediatric cancer patients, rare disease patients, organ transplant waitlist candidates, and pharmaceutical developers, but specifies no population totals.
Fiscal magnitude$2.7Bprovisional · pending reviewSec. 11 specifies $2,622,000,000 available in the Medicare Improvement Fund, and Sec. 7 authorizes $25,000,000 for each of FY 2026 through 2028 ($75,000,000 total) for NIH pediatric drug study programs, totaling $2,697,000,000 in explicitly specified funding/authorizations.
Reach54provisional · pending reviewrigor: heuristic llm
What this bill touches.
Spending vs. restraint+25Aid & alliances+25Public R&D+25Pharmaceutical pricing+25
Who it helps · who it burdens.
Who it helps
- Drug sponsors subject to pediatric study requirementsReceive a 45-day response window following noncompliance letters and are protected from enforcement penalties unless the agency determines they showed a lack of due diligence, with discontinued drugs exempted (Sec. 3(a)–(b)).
- Developers of treatments for rare pediatric diseasesGain extended eligibility to receive rare pediatric disease priority review vouchers through September 30, 2029 (Sec. 5(a)).
- Generic drug developersGain the right to receive disclosures from the Food and Drug Administration regarding whether their proposed formulations match brand-name inactive ingredients, including specific deviating ingredients and quantities (Sec. 10(a)).
- Medical product manufacturers in Abraham Accords countriesReceive technical assistance on manufacturing standards, regulatory convergence, and Food and Drug Administration approval pathways from a newly established regional office (Sec. 9(a)).
- National Institutes of Health pediatric drug studies programAuthorized to receive $25 million annually for fiscal years 2026 through 2028 to support pediatric drug studies (Sec. 7).
Who it burdens
- Cancer drug developersMust conduct molecularly targeted pediatric cancer investigations on new cancer drugs or combinations when required by the Food and Drug Administration, starting three years after enactment (Sec. 2(a), (c)).
- Organ Procurement and Transplantation Network membersMay be assessed registration fees by the Department of Health and Human Services for each candidate placed on the organ transplant waiting list for up to three years to finance network operations (Sec. 8(2)).
Who backs it
- Organ Procurement and Transplantation Network membersPay registration fees when placing patients on the organ transplant waiting list, which fund the operation and awardees of the Organ Procurement and Transplantation Network (Sec. 8(2)).
Who opposes it
- Orphan drug manufacturersHave their seven-year orphan drug market exclusivity narrowed strictly to the specific approved use or indication rather than the broader rare disease or condition (Sec. 6(a)).