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S 2289 112th Congress Senate Health Administrative law and regulatory procedures Advisory bodies Cancer Child health Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Food and Drug Administration (FDA) Government information and archives Medical research

Better Pharmaceuticals and Devices for Children Act of 2012

Introduced: April 17, 2012 Introduced by: Reed, Jack Democratic · Rhode Island See on congress.gov
This bill died when the 112th Congress ended
It never became law before the 112th Congress (2011–2012) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 17, 2012
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Apr 17, 2012
Sponsor introductory remarks on measure. (CR S2395)
Apr 17, 2012
Introduced in Senate
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 Plain-English summary Congressional Research Service

Better Pharmaceuticals and Devices for Children Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to make provisions extending market exclusivity for conducting pediatric studies permanent. Applies such provisions only to completed pediatric studies that are the subject of a written request by the Secretary of Health and Human Services (HHS).

Requires the Secretary to issue internal standard operating procedures that provide for review by the Pediatric Review Committee of any significant modifications to pediatric study plans or written requests by the Secretary for pediatric studies.

Directs the Secretary to make publicly available the medical, statistical, and clinical pharmacology reviews of pediatric studies submitted between January 4, 2002, and September 7, 2007, for which six months of market exclusivity was granted and that resulted in a labeling change.

Establishes a process under which the Secretary may grant an extension to a new drug applicant to defer submission of an assessment of a drug's safety and effectiveness in pediatric populations.

Sets forth enforcement provisions if a persons fails to submit a required assessment, meet requirements for a deferral, or submit a request for approval of a pediatric formulation.

Establishes a procedure for the Secretary and applicant to agree on a pediatric study plan prior to submission of an assessment.

Makes the Pediatric Advisory Committee a permanent committee. Extends the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee for the duration of the Oncologic Drugs Advisory Committee.

Extends for five years the program for humanitarian exemptions for pediatric medical devices.

Reauthorizes through FY2017 a demonstration program to promote pediatric device development.

Reauthorizes a National Institutes of Health (NIH) program of research on pediatric therapeutics.

Requires the Comptroller General (GAO) to evaluate the effectiveness of current federal programs in ensuring that medicines used by children are tested in pediatric populations and properly labeled for use in children.

What's happening now April 17, 2012

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

 Related & companion bills 2
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
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APA
U.S. Congress. (2026). S. 2289: Better Pharmaceuticals and Devices for Children Act of 2012. 112th Congress. Open America. https://openamerica.io/bill/112-S-2289/
MLA
"S. 2289: Better Pharmaceuticals and Devices for Children Act of 2012." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-S-2289/.
Bluebook (legal)
S. 2289, 112th Cong. (2026), https://openamerica.io/bill/112-S-2289/.
Markdown link
[S. 2289: Better Pharmaceuticals and Devices for Children Act of 2012](https://openamerica.io/bill/112-S-2289/)
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