To encourage innovation in the development of pediatric drugs, and for other purposes.
Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.
Summary
What This Bill Does
This bill, To encourage innovation in the development of pediatric drugs, and for other purposes., changes federal law or congressional policy affecting health care providers and patients. The main policy domain is Healthcare, Government Operations, Education.
Who Benefits and How
health care providers and patients may benefit from new authority, funding, eligibility, regulatory clarity, or reduced risk created by the bill.
Who Bears the Burden and How
federal implementing agencies, health care providers and patients may take on implementation duties, reporting obligations, compliance costs, or oversight responsibilities.
Key Provisions
- Section H01338E2A71AC41F286CF2A8D9E7DAFF1: 1. Short title This Act may be cited as the Innovation in Pediatric Drugs Act of 2023.
- Section HD11905C3409C40D788D843B1F874A11B: 2. Pediatric studies of orphan drugs Section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is amended by striking subsection (k). The...
- Section HDB7ABD1F6FFE4A9BA275872FE998B938: 3. Reauthorizing the program for pediatric studies of drugs Section 409I(d)(1) of the Public Health Service Act (42 U.S.C. 284m(d)(1)) is amended in paragraph...
- Section HC7953F50702A46A380B668E34873887D: 4. Ensuring completion of pediatric study requirements Section 505B(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)(2)) is amended by...
- Section HC06EB2843EDB40699F618DCB55DC88C4: 5. FDA report on PREA enforcement Section 508(b) of the Food and Drug Administration Safety and Innovation Act (21 U.S.C. 355c–1(b)) is amended— in paragraph...
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
This bill, To encourage innovation in the development of pediatric drugs, and for other purposes., changes federal law or congressional policy affecting health care providers and patients.
Key Policy Areas
Healthcare, Government Operations, Education
Primary Purpose
This bill, To encourage innovation in the development of pediatric drugs, and for other purposes., changes federal law or congressional policy affecting health care providers and patients.
Policy Domains
Whole bill
Identified Gains
- health care providers and patients
Identified Costs
- federal implementing agencies
- health care providers and patients
Sponsors
Legislative Progress
IntroducedMs. Eshoo (for herself and Mr. McCaul) introduced the following …
Impact analysis is available but no clear stakeholder effects identified. View clause-level analysis →
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "secretary_of_health_and_human_services"
- → Secretary of Health and Human Services
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology