Sponsors (314)
Introduced February 12, 2025 by Michael T. McCaul · Last progress December 2, 2025
This bill increases regulatory clarity, pediatric and transplant-focused initiatives, and transparency that can improve access and oversight, but it does so while raising federal costs, imposing new administrative burdens, and introducing risks that could delay pediatric data, weaken enforcement incentives, and shift incentives for drug developers.
Patients and health systems: clearer, binding FDA determinations and new guidance on when a proposed generic is qualitatively/quantitatively the same as a listed drug, reducing regulatory uncertainty for generic applicants and helping speed development of lower‑cost generic alternatives.
Children, adolescents, and pediatric cancer patients: clearer timelines, guidance, and trial-design expectations plus targeted funding improve the likelihood of clinically meaningful pediatric dosing, safety, and labeling data (including for pediatric cancers and rare pediatric diseases).
Patients, providers, and the public: increased transparency and accountability through formal notice-and-response before enforcement, public reporting of penalties/settlements and GAO study/reporting requirements, which improves oversight and helps stakeholders understand regulatory performance.
Taxpayers and FDA users: multiple provisions increase federal spending and administrative costs (Medicare fund allocation, pediatric study authorizations, overseas FDA engagement, and new implementation duties), creating budgetary pressure and possible diversion of resources from other priorities.
Patients (including children) and clinicians: rules that finalize FDA sameness determinations, delays or limits on enforcement, and delayed applicability of pediatric requirements risk locking in incorrect regulatory positions or slowing generation of pediatric data and labeling, potentially harming patient safety or delaying access to pediatric-appropriate therapies.
Drug developers and future patients: reductions or shifts in incentives (narrowed orphan exclusivity for some uses, earlier fee timing for priority review, publicized penalties, and certain disclosure requirements) could reduce expected returns or raise costs—harming small developers and possibly slowing research into some indications.
Based on analysis of 20 sections of legislative text.
Requires FDA to tell prospective generic drug applicants whether a proposed generic is qualitatively and quantitatively the same as the listed drug and to publish guidance on how sameness is determined; revises pediatric drug-study rules and enforcement, extends rare pediatric disease vouchers, narrows orphan-drug exclusivity scope, provides limited funding for pediatric studies, authorizes OPTN registration fees and EHR integration encouragement, and creates an FDA office to coordinate with Abraham Accords countries. Imposes new reporting and guidance deadlines, requires GAO studies and agency reports, creates a noncompliance/notice process before FDA takes enforcement for pediatric study failures, and includes several implementation timelines (some immediate, some delayed by up to three years or more).