3.0.0 2857 2023-01-15T05:47:34Z 2023-01-15T05:47:34Z House H HR 2003-07-24 108 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2003-08-08T14:30:23Z Referred to 2003-07-24T14:04:10Z Pediatric Research Equity Act of 2003 108 650 S 2003-12-03 Became Public Law No: 108-155. Related bill CRS 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 Introduced in House IntroReferral Intro-H 9 Library of Congress 2003-07-24 Introduced in House IntroReferral 1000 9 Library of Congress G000439 Rep. Greenwood, James C. [R-PA-8] JAMES GREENWOOD R PA C. 8 N E000215 Rep. Eshoo, Anna G. [D-CA-14] ANNA ESHOO D CA G. 14 2003-07-24 True P000555 Rep. Pryce, Deborah [R-OH-15] DEBORAH PRYCE R OH 15 2003-07-24 True W000789 Rep. Wilson, Heather [R-NM-1] HEATHER WILSON R NM 1 2003-10-01 False B001230 Rep. Baldwin, Tammy [D-WI-2] Tammy Baldwin D WI 2 2003-10-01 False W000268 Rep. Weldon, Curt [R-PA-7] CURT WELDON R PA 7 2003-10-01 False A000210 Rep. Andrews, Robert E. [D-NJ-1] ROBERT ANDREWS D NJ E. 1 2003-10-15 False J000163 Rep. Johnson, Nancy L. [R-CT-5] NANCY JOHNSON R CT L. 5 2003-10-15 False S. 650 https://www.congress.gov/bill/108th-congress/senate-bill/650 Health Administrative remedies Child health Child safety Commerce Department of Health and Human Services Drug approvals Drug industry Drugs Families Government Operations and Politics Government paperwork Labeling Law Pharmaceutical research Product safety Science, Technology, Communications Warning labels Health 00 2003-07-24 Introduced in House 2003-08-28T21:39:51Z 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.

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 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 enforcement action.]]>

Pediatric Research Equity Act of 2003 Display Title Pediatric Research Equity Act of 2003 Official Title as Introduced 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 House IH Short Titles as Introduced Pediatric Research Equity Act of 2003 Introduced in House 2003-07-24T04:00:00Z 2003-08-08 Referred to the Subcommittee on Health. 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.