Skip to main content
S 3239 114th Congress Senate Health Cancer Child health Drug safety, medical device, and laboratory regulation Drug therapy Medical research

RACE for Children Act

Introduced: July 14, 2016 Introduced by: Bennet, Michael F. Democratic · Colorado See on congress.gov
Sign in to write a letter Sign in to watch
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 14, 2016
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jul 14, 2016
Introduced in Senate
 Plain-English summary Congressional Research Service

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 requirements for assessing the use of medications in pediatric populations.

Applications and supplements to applications for certain drugs and biological products, including orphan drugs, that could be used to treat pediatric cancer must include an assessment of pediatric use. Upon request, the Food and Drug Administration (FDA) must meet with the sponsor of such a medication to discuss the plan for pediatric studies.

The FDA may require the sponsor of an approved medication that could be used to treat 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 bill limits waivers of pediatric assessment requirements for certain medications that could be used to treat a pediatric cancer for which there is a need for additional treatment options.

The FDA must meet with medication sponsors to discuss a deferral or waiver of the pediatric assessment requirement.
What's happening now July 14, 2016

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

 Committees of jurisdiction 1