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Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries

Titles (4)

Short Titles

Short Titles as Enacted

Pediatric Research Equity Act of 2003

Short Titles - Senate

Short Titles as Passed Senate

Pediatric Research Equity Act of 2003

Short Titles as Introduced

Pediatric Research Equity Act of 2003

Official Titles

Official Titles - Senate

Official Titles 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.


Actions Overview (7)

Date
12/03/2003Became Public Law No: 108-155. (TXT | PDF)
12/03/2003Signed by President.
11/21/2003Presented to President.
11/19/2003Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H11567-11569)
07/23/2003Passed/agreed to in Senate: Passed Senate with amendments by Unanimous Consent.(text as passed Senate: CR S9816-9818)
06/27/2003Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment. With written report No. 108-84. Additional views filed.
03/18/2003Introduced in Senate

All Actions (21)

Date Chamber
12/03/2003Became Public Law No: 108-155. (TXT | PDF)
12/03/2003Signed by President.
11/21/2003SenatePresented to President.
11/19/2003-3:55pmHouseMotion to reconsider laid on the table Agreed to without objection.
11/19/2003-3:55pmHouseOn motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H11567-11569)
11/19/2003-3:27pmHouseDEBATE - The House proceeded with forty minutes of debate on S. 650.
11/19/2003-3:27pmHouseConsidered under suspension of the rules. (consideration: CR H11567-11572)
11/19/2003-3:27pmHouseMr. Bilirakis moved to suspend the rules and pass the bill.
08/08/2003HouseReferred to the Subcommittee on Health.
Action By: Committee on Energy and Commerce
07/24/2003HouseReferred to the House Committee on Energy and Commerce.
07/24/2003-10:04amHouseReceived in the House.
07/24/2003SenateMessage on Senate action sent to the House.
07/23/2003SenatePassed Senate with amendments by Unanimous Consent. (text as passed Senate: CR S9816-9818)
07/23/2003SenateS.Amdt.1360 Amendment SA 1360 agreed to in Senate by Unanimous Consent.
07/23/2003SenateS.Amdt.1360 Amendment SA 1360 proposed by Senator DeWine for Senator Gregg. (consideration: CR S9815-9816; text: CR S9815) Relative to the applicability to new drugs and biological products.
07/23/2003SenateMeasure laid before Senate by unanimous consent. (consideration: CR S9811-9819; text of measure as reported in Senate: CR S9811-9813)
06/27/2003SenatePlaced on Senate Legislative Calendar under General Orders. Calendar No. 183.
06/27/2003SenateCommittee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment. With written report No. 108-84. Additional views filed.
Action By: Committee on Health, Education, Labor, and Pensions
03/19/2003SenateCommittee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment favorably.
Action By: Committee on Health, Education, Labor, and Pensions
03/18/2003SenateRead twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S3898-3900)
03/18/2003SenateSponsor introductory remarks on measure. (CR S3897-3898)

Cosponsors (6)

* = Original cosponsor
CosponsorDate Cosponsored
Sen. Clinton, Hillary Rodham [D-NY]* 03/18/2003
Sen. Gregg, Judd [R-NH]* 03/18/2003
Sen. Dodd, Christopher J. [D-CT]* 03/18/2003
Sen. Kennedy, Edward M. [D-MA]* 03/18/2003
Sen. Murray, Patty [D-WA] 03/19/2003
Sen. Frist, William H. [R-TN] 03/19/2003

Committees (2)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Reports
Senate Health, Education, Labor, and Pensions03/18/2003 Referred to
03/19/2003 Markup by
06/27/2003 Reported by S. Rept. 108-84
House Energy and Commerce07/24/2003 Referred to
House Energy and Commerce Subcommittee on Health08/08/2003 Referred to

A related bill may be a companion measure, an identical bill, a procedurally-related measure, or one with text similarities. Bill relationships are identified by the House, the Senate, or CRS, and refer only to same-congress measures.


Latest Summary (3)

There are 3 summaries for S.650. View summaries

Shown Here:
Public Law No: 108-155 (12/03/2003)

(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.