S. 2295Senate112th Congress (2011-2013)In Committee

Patient Safety and Generic Labeling Improvement Act

Introduced April 18, 2012

Legislative Activity

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2 earlier actions
SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2498)

April 18, 2012

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SenateIntro Referral

Introduced in Senate

April 18, 2012

SenateIntro Referral

Sponsor introductory remarks on measure. (CR S2497-2498, S2499-2500)

April 18, 2012

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2498)

April 18, 2012

Floor Debate

17 members

What members said about S. 2295 on the floor

5 Republicans12 Democrats
Tom Harkin
Sen. Tom HarkinD-IA · Apr 18, 2012

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, I just had a very wonderful phone call from a young Matt Rutherford, a 31-year-old man. I have…

Sheldon Whitehouse
Sen. Sheldon WhitehouseD-RI · Apr 18, 2012

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. First, I want to thank my colleague, Senator Cardin, and just recently Senator Brown of Ohio, for referencing…

Johnny Isakson
Sen. Johnny IsaksonR-GA · Apr 18, 2012

Mr. President, I ask unanimous consent to address the Senate as in morning business. Mr. President, I rise to speak to the Senate, but in a broader sense to the American people and, in particular, to…

Joseph I. Lieberman
Sen. Joseph I. LiebermanD-CT · Apr 18, 2012

Mr. President, before I proceed to the Senator from Missouri, I want to thank my friend from Florida for his principled and passionate statement. He speaks from his own experience--his family's own…

Benjamin L. Cardin
Sen. Benjamin L. CardinD-MD · Apr 18, 2012

Mr. President, I concur with my friend from Mississippi on the importance of passing the RESTORE Act. It is in our transportation reauthorization bill, and it is an important part. It not only helps…

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Patrick J. Leahy
Sen. Patrick J. LeahyD-VT · Apr 18, 2012

Mr. President, today, I am introducing legislation that will protect American consumers by improving the labeling on prescription drugs to promote consumer safety. This important bill will ensure…

Patrick J. Leahy
Sen. Patrick J. LeahyD-VT · Apr 18, 2012

Mr. President, today, I am introducing legislation that will protect American consumers by improving the labeling on prescription drugs to promote consumer safety. This important bill will ensure…

Sherrod Brown
Sen. Sherrod BrownD-OH · Apr 18, 2012

Mr. President, I thank the Senator from Georgia. I so appreciate Senator Isakson's comments about Africa. He is lucky enough to represent the CDC, which is one of the greatest organizations in human…

Jerry Moran
Sen. Jerry MoranR-KS · Apr 18, 2012

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. I ask unanimous consent that I be allowed to address the Senate as in morning business. Mr. President, I am…

Al  Franken
Sen. Al Franken D-MN · Apr 18, 2012

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. I ask unanimous consent to speak as in morning business for about 20 minutes. Mr. President, I rise today to…

Marco Rubio
Sen. Marco RubioR-FL · Apr 18, 2012

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. I ask unanimous consent to speak as in morning business. Mr. President, I think this is topical to the item we…

Claire McCaskill
Sen. Claire McCaskillD-MO · Apr 18, 2012

Mr. President, I spent a lot of my childhood in a very small town in Missouri. From the time I was about 3 years old until the fourth grade, I lived in a town called Lebanon, MO. My dad was a life…

Richard Blumenthal
Sen. Richard BlumenthalD-CT · Apr 18, 2012

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, I ask unanimous consent to speak as in morning business. Mr. President, I noted earlier the very…

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Al  Franken
Sen. Al Franken D-MN · Apr 18, 2012

Mr. President, Gladys Mensing lives in Owatonna, MN. She loves being around people. That is a good thing when one has a family as big as Gladys does. She is the loving mother of 8 children, with 15…

Al  Franken
Sen. Al Franken D-MN · Apr 18, 2012

Mr. President, Gladys Mensing lives in Owatonna, MN. She loves being around people. That is a good thing when one has a family as big as Gladys does. She is the loving mother of 8 children, with 15…

Lamar Alexander
Sen. Lamar AlexanderR-TN · Apr 18, 2012

Mr. President, I ask unanimous consent the order for the quorum call be rescinded. Mr. President, today, the University of Tennessee, where I was once President, announced that our basketball coach,…

Patty Murray
Sen. Patty MurrayD-WA · Apr 18, 2012

Mr. President, today, as Chairman of the Senate Committee on Veterans' Affairs, I am pleased to introduce the Servicemembers Rights Enforcement Improvement Act of 2012. I remain deeply committed to…

Roger F. Wicker
Sen. Roger F. WickerR-MS · Apr 18, 2012

Mr President, this week marks the somber anniversary 2 years ago, on Friday, April 20, 2010, of an explosion on the Deepwater Horizon oilrig in the Gulf of Mexico which took 11 lives and triggered…

Jeanne Shaheen
Sen. Jeanne ShaheenD-NH · Apr 18, 2012

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, the U.S. Postal Service is a fundamental part of our Nation's history and what it means to be an…

Harry Reid
Sen. Harry ReidD-NV · Apr 18, 2012

Madam President, I ask unanimous consent that the order for the quorum call be rescinded.

Bill Text

Latest available legislative text

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Introduced in SenateIssued April 18, 2012

II

112th CONGRESS

2d Session

S. 2295

IN THE SENATE OF THE UNITED STATES

April 18, 2012

Mr. Leahy (for himself, Mr. Franken, Mr. Coons, Mr. Whitehouse, Mr. Bingaman, Mr. Brown of Ohio, and Mr. Blumenthal) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To permit manufacturers of generic drugs to provide additional warnings with respect to such drugs in the same manner that the Food and Drug Administration allows brand names to do so.

1.

Short title

This Act may be cited as the Patient Safety and Generic Labeling Improvement Act.

2.

Warning labeling with respect to generic drugs

Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is amended by adding at the end the following:

(11)
(A)

Notwithstanding any other provision of this Act, the holder of an approved application under this subsection may change the labeling of a drug so approved in the same manner authorized by regulation for the holder of an approved new drug application under subsection (b).

(B)

In the event of a labeling change made under subparagraph (A), the Secretary may order conforming changes to the labeling of the equivalent listed drug and each drug approved under this subsection that corresponds to such listed drug.

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