Pediatric Research Equity Act of 2003

Bill: 108-s-650
Sponsor: Sen. DeWine, Mike [R-OH]
Introduced: 2003-03-18 in the Senate
Policy area: Health
Subjects: 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

Summary:
action_date: 2003-03-18
text: 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.
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.
action_date: 2003-07-23
text: 
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.
action_date: 2003-12-03
text: 

(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.

Legislative actions:
action_date: 2003-12-03
text: Became Public Law No: 108-155.
action_date: 2003-12-03
text: Became Public Law No: 108-155.
action_date: 2003-12-03
text: Signed by President.
action_date: 2003-12-03
text: Signed by President.
action_date: 2003-11-21
text: Presented to President.
action_date: 2003-11-21
text: Presented to President.
action_date: 2003-11-19
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2003-11-19
text: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H11567-11569)
action_date: 2003-11-19
text: Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H11567-11569)
action_date: 2003-11-19
text: DEBATE - The House proceeded with forty minutes of debate on S. 650.
action_date: 2003-11-19
text: Considered under suspension of the rules. (consideration: CR H11567-11572)
action_date: 2003-11-19
text: Mr. Bilirakis moved to suspend the rules and pass the bill.
action_date: 2003-08-08
text: Referred to the Subcommittee on Health.
action_date: 2003-07-24
text: Referred to the House Committee on Energy and Commerce.
action_date: 2003-07-24
text: Received in the House.
action_date: 2003-07-24
text: Message on Senate action sent to the House.
action_date: 2003-07-23
text: Passed Senate with amendments by Unanimous Consent. (text as passed Senate: CR S9816-9818)
action_date: 2003-07-23
text: Passed/agreed to in Senate: Passed Senate with amendments by Unanimous Consent.(text as passed Senate: CR S9816-9818)
action_date: 2003-07-23
text: Measure laid before Senate by unanimous consent. (consideration:  CR S9811-9819; text of measure as reported in Senate:  CR S9811-9813)
action_date: 2003-06-27
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 183.
action_date: 2003-06-27
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment. With written report No. 108-84. Additional views filed.
action_date: 2003-06-27
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment. With written report No. 108-84. Additional views filed.
action_date: 2003-03-19
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment favorably.
action_date: 2003-03-18
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S3898-3900)
action_date: 2003-03-18
text: Sponsor introductory remarks on measure. (CR S3897-3898)
action_date: 2003-03-18
text: Introduced in Senate

Enacted as: number: 108-155