S. 2236: Advancing Breakthrough Therapies for Patients Act of 2012

112th Congress · introduced 2012-03-26 · 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 2012-03-26 · official record
Who proposed it: Sen. Bennet, Michael F. [D-CO] · 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

Advancing Breakthrough Therapies for Patients Act of 2012

Plain summary

Advancing Breakthrough Therapies for Patients Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), at the request of the sponsor of a drug, to expedite the drug's development and review if: (1) it is intended, either alone or in combination, to treat a serious life-threatening disease or condition; and (2) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Authorizes the drug's sponsor to request the Secretary to designate the drug as a breakthrough therapy. Requires the Secretary, within 60 days of such request, to determine whether the drug meets such criteria and, if so, make such designation, followed by appropriate actions to expedite its development and review for approval. Directs the Secretary to issue guidance on implementing requirements with respect to breakthrough therapies and to amend promulgated regulations. Requires the Secretary to contract with an independent entity to evaluate the manner by which the Food and Drug Administration (FDA) has applied the processes for the breakthrough therapy determination, and the impact of such processes on the development and timely availability of innovative treatments for patients affected by serious or life-threatening conditions. Requires an annual report from the Secretary to Congress on drugs for which breakthrough designations were requested and approved.

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

What a vote does

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

A “Nay” vote

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What does this mean? (plain words)

Official text

Advancing Breakthrough Therapies for Patients 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. Bennet, Michael F. [D-CO] · 2 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Sponsor's campaign money: Sen. Bennet, Michael F. [D-CO] reported raising $226,248 (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 (2)

Appropriation: Money a legislature sets aside by law for a specific purpose. Government agencies may spend public money only as it has been appropriated.
Rulemaking: The process agencies use to write regulations that carry out laws passed by Congress or a legislature. Usually an agency publishes a proposed rule, takes public comments, then publishes a final rule.

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-112s2236.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/112/s>

Record fed-us-cong112-s2236 · catalog fed-us-congress-bills-cong112 · updated 2026-11-15 by psicol fed-bills-cong112