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S. 3187 (112th): Food and Drug Administration Safety and Innovation Act

About the bill

Source: Wikipedia

The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program to make eligible rare pediatric diseases. The measure was passed by 96 senators voting for and one voting against.

This summary is from Wikipedia.

Sponsor and status

Thomas “Tom” Harkin

Sponsor. Senator for Iowa. Democrat.

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Last Updated: Jun 27, 2012
Length: 140 pages
May 15, 2012
112th Congress (2011–2013)

Enacted — Signed by the President on Jul 9, 2012

This bill was enacted after being signed by the President on July 9, 2012.

Pub.L. 112-144

1 Cosponsor (1 Republican)


Incorporated legislation

This bill incorporates provisions from:

S. 2516: Food and Drug Administration Safety and Innovation Act

Ordered Reported on May 7, 2012. 69% incorporated. (compare text)

H.R. 5651: Food and Drug Administration Reform Act of 2012

Passed House (Senate next) on May 30, 2012. 61% incorporated. (compare text)

H.R. 3988: Generic Drug and Biosimilar User Fee Act of 2012

Introduced on Feb 8, 2012. 92% incorporated. (compare text)

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

Introduced on Apr 17, 2012. 47% incorporated. (compare text)

S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments

Introduced on Feb 15, 2012. 34% incorporated. (compare text)

H.R. 4132: FAST Act

Introduced on Mar 5, 2012. 80% incorporated. (compare text)

H.R. 2227: Medical Gas Safety Act

Introduced on Jun 16, 2011. 34% incorporated. (compare text)

H.R. 5334: To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies.

Introduced on May 7, 2012. 80% incorporated. (compare text)

H.R. 4087: Prescription Drug Labeling Promotion Act of 2012

Introduced on Feb 24, 2012. 68% incorporated. (compare text)


May 15, 2012

Bills and resolutions are referred to committees which debate the bill before possibly sending it on to the whole chamber.

May 24, 2012
Passed Senate (House next)

The bill was passed in a vote in the Senate. It goes to the House next.

Jun 20, 2012
Passed House with Changes (back to Senate)

The House passed the bill with changes not in the Senate version and sent it back to the Senate to approve the changes. The vote was by voice vote so no record of individual votes was made.

Jun 26, 2012
Senate Agreed to Changes

The bill was passed by both chambers in identical form. It goes to the President next who may sign or veto the bill.

Jul 9, 2012
Enacted — Signed by the President

The President signed the bill and it became law.

S. 3187 (112th) was a bill in the United States Congress.

A bill must be passed by both the House and Senate in identical form and then be signed by the President to become law.

Bills numbers restart every two years. That means there are other bills with the number S. 3187. This is the one from the 112th Congress.

This bill was introduced in the 112th Congress, which met from Jan 5, 2011 to Jan 3, 2013. Legislation not passed by the end of a Congress is cleared from the books.

How to cite this information.

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“S. 3187 — 112th Congress: Food and Drug Administration Safety and Innovation Act.” 2012. March 28, 2023 <>

Where is this information from?

GovTrack automatically collects legislative information from a variety of governmental and non-governmental sources. This page is sourced primarily from, the official portal of the United States Congress. is generally updated one day after events occur, and so legislative activity shown here may be one day behind. Data via the congress project.