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A bill to amend the Federal Food, Drug, and Cosmetic Act to establish a program to increase the development of new drugs to treat pediatric cancers, and for other purposes.

USA115th CongressS-456| Senate 
| Updated: 2/27/2017
Michael F. Bennet

Michael F. Bennet

Democratic Senator

Colorado

Cosponsors (4)
Angus S. King (Independent)Chris Van Hollen (Democratic)Marco Rubio (Republican)Cory Gardner (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Research to Accelerate Cures and Equity for Children Act or the RACE for Children Act This bill amends the Federal Food, Drug, and Cosmetic Act to expand Food and Drug Administration (FDA) requirements for sponsors of certain drugs and biological products for adult cancer to assess the use of their medications in pediatric populations. (Currently, applications for FDA approval of new medications or new uses of medications must include pediatric assessments of safety and effectiveness for claimed indications, with exceptions.) The pediatric assessment for medications, including orphan drugs, that are used to treat cancer in adults and target a molecule germane to pediatric cancer must assess the safety and effectiveness of the medication for pediatric cancer. The bill limits waivers of pediatric assessments for medications that target a molecule germane to a pediatric cancer for which there is a need for additional treatment options. The FDA may require the sponsor of an approved medication that targets a molecule germane to pediatric cancer to complete a pediatric assessment if: (1) the medication is used for a substantial number of pediatric cancer patients, or (2) there is reason to believe the medication would have a meaningful therapeutic benefit over existing therapies for pediatric cancer patients. The FDA committee that reviews requests for pediatric studies must implement a plan to achieve earlier submission of pediatric studies. (Currently, completion of pediatric clinical studies requested by the FDA extends the patents or marketing exclusivity period for a medication by six months, with exceptions.) The FDA must act within 120 days on proposed pediatric study requests and proposed amendments to requests.
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Timeline
Feb 27, 2017
Introduced in Senate
Feb 27, 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mar 3, 2017

Latest Companion Bill Action

HR 115-1231
Referred to the Subcommittee on Health.
  • February 27, 2017
    Introduced in Senate


  • February 27, 2017
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • March 3, 2017

    Latest Companion Bill Action

    HR 115-1231
    Referred to the Subcommittee on Health.

Health

Related Bills

  • HR 115-1231: To amend the Federal Food, Drug, and Cosmetic Act to establish a program to increase the development of new drugs to treat pediatric cancers, and for other purposes.
CancerChild healthCongressional oversightDrug safety, medical device, and laboratory regulationDrug therapyMedical research

A bill to amend the Federal Food, Drug, and Cosmetic Act to establish a program to increase the development of new drugs to treat pediatric cancers, and for other purposes.

USA115th CongressS-456| Senate 
| Updated: 2/27/2017
Research to Accelerate Cures and Equity for Children Act or the RACE for Children Act This bill amends the Federal Food, Drug, and Cosmetic Act to expand Food and Drug Administration (FDA) requirements for sponsors of certain drugs and biological products for adult cancer to assess the use of their medications in pediatric populations. (Currently, applications for FDA approval of new medications or new uses of medications must include pediatric assessments of safety and effectiveness for claimed indications, with exceptions.) The pediatric assessment for medications, including orphan drugs, that are used to treat cancer in adults and target a molecule germane to pediatric cancer must assess the safety and effectiveness of the medication for pediatric cancer. The bill limits waivers of pediatric assessments for medications that target a molecule germane to a pediatric cancer for which there is a need for additional treatment options. The FDA may require the sponsor of an approved medication that targets a molecule germane to pediatric cancer to complete a pediatric assessment if: (1) the medication is used for a substantial number of pediatric cancer patients, or (2) there is reason to believe the medication would have a meaningful therapeutic benefit over existing therapies for pediatric cancer patients. The FDA committee that reviews requests for pediatric studies must implement a plan to achieve earlier submission of pediatric studies. (Currently, completion of pediatric clinical studies requested by the FDA extends the patents or marketing exclusivity period for a medication by six months, with exceptions.) The FDA must act within 120 days on proposed pediatric study requests and proposed amendments to requests.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Feb 27, 2017
Introduced in Senate
Feb 27, 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mar 3, 2017

Latest Companion Bill Action

HR 115-1231
Referred to the Subcommittee on Health.
  • February 27, 2017
    Introduced in Senate


  • February 27, 2017
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • March 3, 2017

    Latest Companion Bill Action

    HR 115-1231
    Referred to the Subcommittee on Health.
Michael F. Bennet

Michael F. Bennet

Democratic Senator

Colorado

Cosponsors (4)
Angus S. King (Independent)Chris Van Hollen (Democratic)Marco Rubio (Republican)Cory Gardner (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 115-1231: To amend the Federal Food, Drug, and Cosmetic Act to establish a program to increase the development of new drugs to treat pediatric cancers, and for other purposes.
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
CancerChild healthCongressional oversightDrug safety, medical device, and laboratory regulationDrug therapyMedical research