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Revises subsection (d) (Funding) to authorize the Director of the NIH to make available up to 1 percent of the amount made available for pediatric research to each national research institute and national center under this title for pediatric research under this section for fiscal years 2026 through 2030.
Amends subsection (d) of 21 U.S.C. 355c (section 505B(d) of the FD&C Act) to relabel certain paragraphs, modify the circumstances under which a drug or biological product may be subject to action under section 303, add a limitation preventing enforcement for products no longer marketed, and add a new due diligence procedure requiring issuance of a noncompliance letter, a 45-day response period, and a review to determine lack of due diligence.
Amends 21 U.S.C. 333(f)(4)(A) by including a reference to 505B in the list of provisions in that subsection.
Amends subsection (b) of 21 U.S.C. 355c-1 by adjusting punctuation in existing paragraphs (11), (15), and (16) and by adding a new paragraph (17) that requires a listing of penalties, settlements, or payments under 21 U.S.C. 353 (section 303 of the FD&C Act) for failures to comply with requirements under section 505B, including for each item the drug name, the sponsor, and the amount.
Changes how FDA enforces pediatric study requirements, increases transparency about penalties for failures to comply, allows NIH to direct a small portion of pediatric research funds to a pediatric drug-studies program, and narrows automatic pediatric-study obligations for drugs with orphan designation. The bill requires a written noncompliance notice and a 45-day response window before finding a sponsor lacked due diligence, adds a public listing of penalties/settlements tied to pediatric-study failures, permits NIH to set aside up to 1% of certain pediatric research budgets for a pediatric-studies program (FY2026–2030), and exempts most orphan drugs from automatic pediatric-study triggers unless pediatric assessment would offer meaningful therapeutic benefit.
Amend paragraph (1) of section 505B(d) by striking the words "Beginning 270" and inserting the heading "Noncompliance letter.—".
Amend paragraph (2)(A) of section 505B(d) by striking the words "The drug or" and inserting the heading "Effect of noncompliance.—".
Amend paragraph (2)(B) of section 505B(d) by replacing the parenthetical exception so that a drug or biological product is subject to action under section 303 only if the person demonstrated a lack of due diligence in satisfying the applicable requirement.
Add new paragraph (3) (Limitation): The Secretary shall not issue enforcement actions under section 303 for failures under this subsection for a drug or biological product that is no longer marketed.
Add new paragraph (4)(A) (Due diligence): Before concluding a person failed to submit or otherwise meet the requirement, the Secretary must issue a noncompliance letter pursuant to paragraph (1).
Who is affected and how:
Drug sponsors and manufacturers: They gain stronger procedural protections before FDA can find a lack of due diligence (written notice + 45-day response). They will also face increased public transparency because penalties/settlements tied to pediatric-study failures will be publicly listed with drug name, sponsor, and amount.
FDA and HHS: Agencies must adjust enforcement practices, prepare or update guidance, hold public meetings, maintain the new public penalty list, and administer the orphan-drug exemption policy. FDA will also need to coordinate with GAO and NIH on the mandated study and program implementation.
NIH and research institutes/centers: NIH receives explicit authority to reallocate a small portion (up to 1%) of pediatric research funds at each national research institute/center to a Program for pediatric studies of drugs for FY2026–2030. This can create new targeted support for pediatric drug studies but uses existing pediatric research budgets rather than new appropriations.
Pediatric patients and families, including children with rare diseases: The orphan-drug exemption may reduce the number of automatic pediatric assessments for many drugs developed for rare conditions, which could delay pediatric data generation for some conditions. Conversely, the NIH set-aside and focused program could support targeted pediatric studies.
Rare-disease (orphan-disease) communities: Sponsors of orphan drugs may face fewer automatic pediatric obligations, potentially speeding development for adult indications or reducing regulatory burden, but patient advocates may be concerned about reduced pediatric data collection for rare pediatric illnesses.
Oversight and transparency stakeholders: GAO will study effects of the orphan exemptions, and public reporting of penalties increases transparency for policymakers, clinicians, and patient groups.
Overall balance and likely outcomes:
Expand sections to see detailed analysis
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S1347)
Introduced February 25, 2025 by John F. Reed · Last progress February 25, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S1347)
Introduced in Senate