3.0.0 650 2023-01-15T23:03:28Z 2023-01-15T23:03:28Z Senate S S 2003-03-18 108 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2003-08-08T14:45:10Z Referred to 2003-07-25T00:40:26Z sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported by 2003-06-27T05:50:57Z Markup by 2003-03-19T21:55:21Z Referred to 2003-03-19T01:34:02Z S. Rept. 108-84 Pediatric Research Equity Act of 2003 108 2857 HR 2003-08-08 Referred to the Subcommittee on Health. Related bill CRS 2003-12-03 Became Public Law No: 108-155. President E40000 2 House floor actions 2003-12-03 Became Public Law No: 108-155. BecameLaw 36000 9 Library of Congress 2003-12-03 Signed by President. President E30000 2 House floor actions 2003-12-03 Signed by President. BecameLaw 36000 9 Library of Congress 2003-11-21 Presented to President. Floor E20000 2 House floor actions 2003-11-21 Presented to President. President 28000 9 Library of Congress 2003-11-19 15:55:22 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2003-11-19 15:55:05 On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H11567-11569) Floor H37300 2 House floor actions 2003-11-19 15:55:05 Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H11567-11569) Floor 8000 9 Library of Congress 2003-11-19 15:27:31 DEBATE - The House proceeded with forty minutes of debate on S. 650. Floor H8D000 2 House floor actions 2003-11-19 15:27:29 Considered under suspension of the rules. (consideration: CR H11567-11572) Floor H30000 2 House floor actions 2003-11-19 15:27:12 Mr. Bilirakis moved to suspend the rules and pass the bill. Floor H30300 2 House floor actions 2003-08-08 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2003-07-24 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2003-07-24 10:04:19 Received in the House. Floor H14000 2 House floor actions 2003-07-24 Senate Message on Senate action sent to the House. Floor 2003-07-23 Senate Passed Senate with amendments by Unanimous Consent. (text as passed Senate: CR S9816-9818) Floor 2003-07-23 Passed/agreed to in Senate: Passed Senate with amendments by Unanimous Consent.(text as passed Senate: CR S9816-9818) Floor 17000 9 Library of Congress 2003-07-23 Senate Measure laid before Senate by unanimous consent. (consideration: CR S9811-9819; text of measure as reported in Senate: CR S9811-9813) Floor 2003-06-27 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 183. Calendars 2003-06-27 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment. With written report No. 108-84. Additional views filed. Committee 2003-06-27 Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment. With written report No. 108-84. Additional views filed. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2003-03-19 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment favorably. Committee 2003-03-18 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S3898-3900) IntroReferral 2003-03-18 Sponsor introductory remarks on measure. (CR S3897-3898) IntroReferral B00100 9 Library of Congress 2003-03-18 Introduced in Senate IntroReferral 10000 9 Library of Congress D000294 Sen. DeWine, Mike [R-OH] MICHAEL DEWINE R OH N C001041 Sen. Clinton, Hillary Rodham [D-NY] HILLARY CLINTON D NY R 2003-03-18 True G000445 Sen. Gregg, Judd [R-NH] Judd Gregg R NH 2003-03-18 True D000388 Sen. Dodd, Christopher J. [D-CT] CHRISTOPHER DODD D CT JOHN 2003-03-18 True K000105 Sen. Kennedy, Edward M. [D-MA] EDWARD KENNEDY D MA MOORE 2003-03-18 True M001111 Sen. Murray, Patty [D-WA] Patty Murray D WA 2003-03-19 False F000439 Sen. Frist, William H. [R-TN] WILLIAM FRIST R TN H. 2003-03-19 False 2003-07-15T04:00:00Z S. 650, Pediatric Research Equity Act of 2003 http://www.cbo.gov/publication/14632 <p>Cost estimate for the bill as reported by the Senate Committee on Health, Education, Labor, and Pensions on June 27, 2003</p> 2003-07-15T04:00:00Z S. 650, Pediatric Research Equity Act of 2003 https://www.cbo.gov/publication/14632 Cost estimate for the bill as reported by the Senate Committee on Health, Education, Labor, and Pensions on June 27, 2003 Public Law 108-155 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 Labeling Law Licenses Pharmaceutical research Product safety Science, Technology, Communications Warning labels Health 00 2003-03-18 Introduced in Senate 2006-11-28T17:35:40Z Permits deferral of such assessments under specified circumstances.

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.

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 of Health and Human Services 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 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 and subject to enforcement action.]]>

35 2003-07-23 Passed Senate amended 2007-05-09T21:37:15Z Pediatric Research Equity Act of 2003 - 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 of Health and Human Services 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.]]>

49 2003-12-03 Public Law 2004-01-16T19:57:39Z (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.]]>

Pediatric Research Equity Act of 2003 Display Title Pediatric Research Equity Act of 2003 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. Introduced in Senate IS Short Titles as Introduced Pediatric Research Equity Act of 2003 Short Titles as Passed Senate Pediatric Research Equity Act of 2003 S Senate Short Titles as Enacted Pediatric Research Equity Act of 2003 1360 108 SAMDT Relative to the applicability to new drugs and biological products. 2022-02-25T17:33:46Z 2003-07-23 Amendment SA 1360 agreed to in Senate by Unanimous Consent. SA 1360 https://www.congress.gov/amendment/108th-congress/senate-amendment/1360 G000445 Sen. Gregg, Judd [R-NH] Judd Gregg R NH 2003-07-23T04:00:00Z 2003-07-23T04:00:00Z Senate 108 S Senate S 650 Pediatric Research Equity Act of 2003 2023-01-15T23:03:28Z 6 2003-07-23 0 Senate Amendment SA 1360 agreed to in Senate by Unanimous Consent. Floor 2003-07-23 0 Senate 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. Floor 2003-07-23 Senate amendment proposed (on the floor): Amendment SA 1360 proposed by Senator DeWine for Senator Gregg.(consideration: CR S9815-9816; text: CR S9815) Floor 93000 9 Library of Congress 2003-07-23 Senate amendment agreed to: Amendment SA 1360 agreed to in Senate by Unanimous Consent. Floor 94000 9 Library of Congress 2003-07-23 Senate amendment submitted Floor 91000 9 Library of Congress Enrolled Bill Referred in House 2003-07-24T04:00:00Z Engrossed in Senate 2003-07-23T04:00:00Z Reported to Senate 2003-06-27T04:00:00Z Introduced in Senate 2003-03-18T05:00:00Z 2003-12-04T04:59:59Z https://www.govinfo.gov/content/pkg/PLAW-108publ155/xml/PLAW-108publ155.xml Public Law 2003-12-03 Became Public Law No: 108-155. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.