S. 2289: Better Pharmaceuticals and Devices for Children Act of 2012

112th Congress · introduced 2012-04-17 · Health · Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

federal

Follow this bill, step by step

Where it came from: introduced 2012-04-17 · official record
Who proposed it: Sen. Reed, Jack [D-RI] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Not final yet: this can still change. We check for updates every day.
If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Better Pharmaceuticals and Devices for Children Act of 2012

Plain summary

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.

Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

Better Pharmaceuticals and Devices for Children Act of 2012

Source: Congressional Research Service summary (Introduced in Senate)

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Sen. Reed, Jack [D-RI] · 3 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Patty Murray (D-WA)

Sponsor's campaign money: Sen. Reed, Jack [D-RI] reported raising $3.7 million (2025–2026). Details. Shown for context only; it does not mean any donor supported this bill.

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (1)

Exemption: A rule that removes certain people, property or activities from a tax or requirement.

Plain meanings written from linked sources. All words.

Sources

Congressional Research Service summary (Introduced in Senate)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-112s2289.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/112/s>

Record fed-us-cong112-s2289 · catalog fed-us-congress-bills-cong112 · updated 2026-11-15 by psicol fed-bills-cong112