Pediatric Research Equity Act of 2003
Latest action · Dec 3, 2003 Became Public Law No: 108-155.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedMar 18, 2003
- Passed SenateJul 23, 2003
- Passed HouseNov 19, 2003
- To the PresidentNov 21, 2003
- Became lawDec 3, 2003Public Law 108-155
Summary
(This measure has not been amended since it was passed by the Senate on July 23, 2003. The summary of that version is repeated here.)
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.
Cosponsors 6
Members who signed on, in the order they did. Signatures ran from Mar 18, 2003 to Mar 19, 2003; 4 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-CT | Christopher J. Dodd | Original | Mar 18, 2003 |
| D-MA | Edward M. Kennedy | Original | Mar 18, 2003 |
| D-NY | Hillary Rodham Clinton | Original | Mar 18, 2003 |
| R-NH | Judd Gregg | Original | Mar 18, 2003 |
| D-WA | Patty Murray | Mar 19, 2003 | |
| R-TN | William H. Frist | Mar 19, 2003 |
Committees 2
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| Senate | Health, Education, Labor, and Pensions Committee | Referred Mar 19, 2003Markup Mar 19, 2003Reported Jun 27, 2003 |
| House | Energy and Commerce Committee | Referred Jul 25, 2003 |
| Health Subcommittee | Referred Aug 8, 2003 |
Actions 20
Everything that happened, newest first.
- Dec 3, 2003Signed by President.
- Dec 3, 2003Became Public Law No: 108-155.
- Nov 21, 2003Presented to President.
- Nov 19, 2003Mr. Bilirakis moved to suspend the rules and pass the bill.
- Nov 19, 2003Considered under suspension of the rules. (consideration: CR H11567-11572)
- Nov 19, 2003DEBATE - The House proceeded with forty minutes of debate on S. 650.
- Nov 19, 2003Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H11567-11569)
- Nov 19, 2003Motion to reconsider laid on the table Agreed to without objection.
- Aug 8, 2003Referred to the Subcommittee on Health.
- Jul 24, 2003Message on Senate action sent to the House.
- Jul 24, 2003Received in the House.
- Jul 24, 2003Referred to the House Committee on Energy and Commerce.
- Jul 23, 2003Measure laid before Senate by unanimous consent. (consideration: CR S9811-9819; text of measure as reported in Senate: CR S9811-9813)
- Jul 23, 2003Passed/agreed to in Senate: Passed Senate with amendments by Unanimous Consent. (text as passed Senate: CR S9816-9818)
- Jun 27, 2003Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment. With written report No. 108-84. Additional views filed.
- Jun 27, 2003Placed on Senate Legislative Calendar under General Orders. Calendar No. 183.
- Mar 19, 2003Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment favorably.
- Mar 18, 2003Introduced in Senate
- Mar 18, 2003Sponsor introductory remarks on measure. (CR S3897-3898)
- Mar 18, 2003Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S3898-3900)
In the Congressional Record 3
Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.
| Where | In the Record | Members | Date |
|---|---|---|---|
| House | Debate and remarks H11567–H11572Text printed H11567–H11569 | Anna G. Eshoo D-CA, Bart Stupak D-MI, Deborah Pryce R-OH, Henry A. Waxman D-CA, James C. Greenwood R-PA, John D. Dingell D-MI, Michael Bilirakis R-FL, Sherrod Brown D-OH | Nov 19, 2003 |
| Senate | Debate and remarks S9811–S9819Text printed S9811–S9813, S9816–S9818Amendments S9809, S9811, S9815 | Christopher J. Dodd D-CT, Edward M. Kennedy D-MA, Hillary Rodham Clinton D-NY, Judd Gregg R-NH (amendment), Mike DeWine R-OH | Jul 23, 2003 |
| Senate | Debate and remarks S3897Text printed S3898–S3900 | Mike DeWine R-OH (text) | Mar 18, 2003 |
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Committee report
Congressional Budget Office cost estimates 2
- Jul 15, 2003S. 650, Pediatric Research Equity Act of 2003<p>Cost estimate for the bill as reported by the Senate Committee on Health, Education, Labor, and Pensions on June 27, 2003</p>
- Jul 15, 2003S. 650, Pediatric Research Equity Act of 2003Cost estimate for the bill as reported by the Senate Committee on Health, Education, Labor, and Pensions on June 27, 2003
CRS reports 8
Congressional Research Service work that CRS links to this bill or the law it became, newest first.
Cite it 8
Products on other subjects that cite it, usually among other measures.
| Product | Title | Kind | Published |
|---|---|---|---|
| R45792 | Off-Label Use of Prescription Drugs | Report | Feb 23, 2021 |
| R41983 | How FDA Approves Drugs and Regulates Their Safety and Effectiveness | Report | May 8, 2018 |
| R44961 | FDA Reauthorization Act of 2017 (FDARA, P.L. 115-52) Archived | Report | Sep 21, 2017 |
| R42680 | The Food and Drug Administration Safety and Innovation Act (FDASIA, P.L. 112-144) Archived | Report | Feb 4, 2013 |
| R42564 | FDA User Fees and the Regulation of Drugs, Biologics, and Devices: Comparative Analysis of S. 3187 and H.R. 5651 Archived | Report | Jun 26, 2012 |
Amendments 1
Amendments offered to this bill.
| Amendment | Description | Offered by | Status |
|---|---|---|---|
| SA 1360 | Relative to the applicability to new drugs and biological products. | Judd Gregg R-NH | Amendment SA 1360 agreed to in Senate by Unanimous Consent. |
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 2857 | Pediatric Research Equity Act of 2003 | Related bill | Aug 8, 2003 |
Titles 4
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- A bill to amend the Federal Food, Drug, and Cosmetic Act to authorize the Food and Drug Administration to require certain research into drugs used in pediatric patients.
- Short Titles as Introduced
- Pediatric Research Equity Act of 2003
- Short Titles as Passed Senate
- Pediatric Research Equity Act of 2003
- Short Titles as Enacted
- Pediatric Research Equity Act of 2003
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative remedies
- Child health
- Child safety
- Clinical trials
- Commerce
- Department of Health and Human Services
- Drug approvals
- Drug industry
- Drugs
- Families
- Government Operations and Politics
- Government paperwork
- Health
- Labeling
- Law
- Licenses
- Pharmaceutical research
- Product safety
- Science, Technology, Communications
- Warning labels
Text 5
Each version as it was printed, newest first.
- —Enrolled Bill
- Jul 24, 2003Referred in House
- Jul 23, 2003Engrossed in Senate
- Jun 27, 2003Reported to Senate
- Mar 18, 2003Introduced in Senate
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.