Pediatric Research Equity Act of 2003
Public Law 108-155 · S. 650 · 108th Congress · began in the Senate
Signed by George W. Bush (R) on Dec 3, 2003 · Health
Sponsor: Sen. Mike DeWine (R-OH)
Cosponsors (6): Sen. Hillary Clinton, Sen. Judd Gregg,
Passage votes
- HouseVoice vote
- SenateUnanimous consent
Data notes
The final version of the law, as each chamber passed it. A chamber that passed it by voice vote or unanimous consent has no count. “Method not stated” means the record does not say how the chamber voted. Where the record has a member-by-member vote, the “Who voted for it” section shows who voted yea.
Summary
The Congressional Research Service’s plain-language summary of what the law does.
Pediatric Research Equity Act of 2003 - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to require license applications for new drugs and biological products to assess such drug's or product's safety and effectiveness for relevant pediatric subpopulations, including dosage.
Permits deferral of such assessments under specified circumstances, including if the Secretary of Health and Human Services finds that the drug or biological product is ready for approval for use in adults before pediatric studies are complete.
Permits full waiver of such assessments under certain conditions, including if: (1) studies are highly impractical or impossible; or (2) there is no meaningful therapeutic advantage or benefit in the pediatric population and the drug or biological product is not likely to be used in a substantial number of pediatric patients.
Permits partial waivers at the request of an applicant for a specific pediatric subpopulation if any of the full waiver grounds apply to that subpopulation or reasonable attempts for a pediatric formulation for that subpopulation have failed.
Requires labels to provide indication in cases in which a waiver has been granted due to evidence a product would be unsafe or ineffective in pediatric populations.
Authorizes the Secretary to specify a date for submission of pediatric assessments if: (1) the drug or biological product would represent a meaningful therapeutic benefit for pediatric patients for one or more claimed indications and the absence of adequate labeling could pose significant risks to pediatric patients; or (2) it is used for a substantial number of pediatric patients for the labeled indications and the absence of adequate labeling could pose significant risks to pediatric patients. Sets forth criteria for full waiver and partial waivers of such requirement. Requires labels to provide indication in cases in which a waiver has been granted due to evidence a product would be unsafe or ineffective in pediatric populations.
Requires the Secretary to issue a written request for related pediatric studies under the Public Health Service Act or under this Act before requiring an assessment for a drug. Directs the Secretary, after determining that there is no agreement to such a written request, to certify whether the Secretary has sufficient funds to conduct the study under the Public Health Service Act, taking into account prioritization of drugs for which pediatric studies are needed.
States that if a person fails to submit an assessment under this Act, or a request for approval of a pediatric formulation, the relevant drug or biological product may be considered misbranded solely because of that failure and subject to relevant enforcement action.
Provides that the new authority under this Act to require pediatric studies shall only remain in effect so long as the pediatric exclusivity provisions under the Federal Food, Drug, and Cosmetic Act also remain in effect (until October 1, 2007).
(Sec. 4) Declares that the provisions of this Act pertaining to research into pediatric uses for new drugs and biological products shall apply to license applications for such drugs and products submitted to the Secretary on or after April 1, 1999. Specifies procedures for the treatment of applications submitted between April 1, 1999, and the date of the enactment of this Act with respect to which waivers or deferrals were granted under previous regulations and with respect to which no waivers or deferrals were granted.
Committees
The committees the bill was sent to, and what each did with it.
Data notes
A committee links to its page only where it exists in the current Congress; older and renamed committees are named without a link.
Related bills
1 bill the Library of Congress relates to this one.
H.R. 2857Related bill
Pediatric Research Equity Act of 2003
Data notes
Related bills are identified by the Congressional Research Service, the House and the Senate: companion and identical bills, bills with similar text, bills that were folded into this law, and rules that brought it to the floor. A bill that is itself a public law in this site’s data links here; the others link to Congress.gov.
Timeline
From introduction to signing, newest first: the committees, the floor and the president. 20 actions.
- Dec 3, 2003Became lawBecame law · Became Public Law No: 108-155.
- Became lawBecame law · Signed by President.
- Nov 21, 2003FloorFloor · Presented to President.
- Nov 19, 2003FloorFloor · Motion to reconsider laid on the table Agreed to without objection.
- FloorFloor · On motion to suspend the rules and pass the bill Agreed to by voice vote.
- FloorFloor · DEBATE - The House proceeded with forty minutes of debate on S. 650.
- FloorFloor · Considered under suspension of the rules.
- FloorFloor · Mr. Bilirakis moved to suspend the rules and pass the bill.
- Aug 8, 2003CommitteeCommittee · Referred to the Subcommittee on Health.
- Jul 24, 2003FloorFloor · Received in the House.
- FloorFloor · Message on Senate action sent to the House.
- CommitteeCommittee · Referred to the House Committee on Energy and Commerce.
- Jul 23, 2003FloorFloor · Passed Senate with amendments by Unanimous Consent.
- FloorFloor · Measure laid before Senate by unanimous consent.
- Jun 27, 2003CalendarCalendar · Placed on Senate Legislative Calendar under General Orders. Calendar No. 183.
- CommitteeCommittee · Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment. With written report No. 108-84. Additional views filed.
- Mar 19, 2003CommitteeCommittee · Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment favorably.
- Mar 18, 2003CommitteeCommittee · Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- CommitteeCommittee · Sponsor introductory remarks on measure. (CR S3897-3898)
- IntroducedIntroduced · Introduced in Senate
Data notes
Every action the Library of Congress lists for the bill, from introduction to signing, plus the dated committee hearings. The source lists many steps twice (the chamber’s own entry and the Library of Congress copy, or a presidential and a became-law entry with the same words); those are shown once. Amendments are listed in their own section.
Amendments
1 amendment offered to the bill, with the last recorded step of each.
- Agreed to
S.Amdt. 1360SenateSen. Judd GreggR-NH· offered Jul 23, 2003Agreed to
Relative to the applicability to new drugs and biological products.
Jul 23, 2003: Amendment SA 1360 agreed to in Senate by Unanimous Consent.
Data notes
Amendments offered to this bill in either chamber, as the Library of Congress records them: each with a status read from its last recorded step: agreed to, rejected, withdrawn, ruled out of order, fell with another amendment, or offered with no vote recorded (most Senate amendments are only ever offered). The wording of each amendment is the source’s. Amendments to amendments and amendments to other bills are not listed.
Official record
The bill’s full text is on Congress.gov. Data through Oct 7, 2026.