S. 511Senate109th Congress (2005-2007)In Committee

RU-486 Suspension and Review Act of 2005

A bill to provide that the approved application under the Federal Food, Drug, and Cosmetic Act for the drug commonly known as RU-486 is deemed to have been withdrawn, to provide for the review by the Comptroller General of the United States of the process by which the Food and Drug Administration approved such drug, and for other purposes.

Sponsored by Jim DeMintSen. Jim DeMint (R-SC)
Introduced March 3, 2005

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 S2020-2021)

March 3, 2005

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SenateIntro Referral

Introduced in Senate

March 3, 2005

SenateIntro Referral

Sponsor introductory remarks on measure. (CR S2020)

March 3, 2005

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2020-2021)

March 3, 2005

Floor Debate

21 members

What members said about S. 511 on the floor

13 Republicans8 Democrats
Robert C. Byrd
Sen. Robert C. ByrdD-WV · Mar 3, 2005

Mr. President, today I am, again, introducing legislation designed to fulfill an important promise made by the Federal Government to the people of my State and my region some 40 years ago. That…

Dianne Feinstein
Sen. Dianne FeinsteinD-CA · Mar 3, 2005

Mr. President, in light of the most recent evidence uncovered about Enron's participation in the Western Energy Crisis, I rise today to introduce the Energy Market Oversight Bill with Senators Levin,…

Edward M. Kennedy
Sen. Edward M. KennedyD-MA · Mar 3, 2005

Mr. President, it is a privilege to join Senator Sessions, Senator Durbin and Senator Dodd in introducing the ``National All Schedules Prescription Electronic Reporting Act.'' Our goal is to help…

Mike DeWine
Sen. Mike DeWineR-OH · Mar 3, 2005

Mr. President, today, I am pleased to join with Senators Levin, Stabenow, Reed, and Voinovich to introduce the National Invasive Species Council Act--a bill to permanently establish the National…

Ron Wyden
Sen. Ron WydenD-OR · Mar 3, 2005

Mr. President, the pace of technological innovation offers American consumers an eye-catching array of electronic gadgets. But for every new lap top or HDTV that goes home from the store with a…

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Lamar Alexander
Sen. Lamar AlexanderR-TN · Mar 3, 2005

Mr. President, today I am here with Senator Dodd and on behalf of Senator Enzi and Senator Kennedy to introduce the Caring for Children Act of 2005 which reauthorizes the Child Care and Development…

Norm Coleman
Sen. Norm ColemanR-MN · Mar 3, 2005

Mr. President, traveling throughout rural Minnesota, I see a very real need for the revitalization and rebuilding of Main Streets, and this is why today I am introducing the Rural Renaissance Act…

Susan M. Collins
Sen. Susan M. CollinsR-ME · Mar 3, 2005

Mr. President, today I am introducing the National Women's History Museum Act of 2005. I appreciate the support of my colleagues who have helped in this important effort and who have agreed to be…

Christopher S. Bond
Sen. Christopher S. BondR-MO · Mar 3, 2005

Mr. President, I introduced S. 503, the Education Begins At Home Act. It is at the desk. It is cosponsored by Senators Talent and DeWine. I invite my colleagues to look at it and join with me in this…

Michael B. Enzi
Sen. Michael B. EnziR-WY · Mar 3, 2005

Mr. President, today I am pleased to be joined by Senators Kennedy, Alexander and Dodd in introducing the ``Caring for Children Act of 2005'' which reauthorizes the Child Care and Development Block…

Chuck Grassley
Sen. Chuck GrassleyR-IA · Mar 3, 2005

Mr. President, America is a nation of sports fans and sports players. In fact, it is hard to imagine something more influential in today's society than athletics. As children, we grow up emulating…

Rick Santorum
Sen. Rick SantorumR-PA · Mar 3, 2005

I rise today to introduce with Senator Rockefeller the bipartisan Fire Sprinkler Incentive Act of 2005. Passage of this Act would serve greatly to help reduce the tremendous annual economic and human…

Tom Harkin
Sen. Tom HarkinD-IA · Mar 3, 2005

Mr. President, today I, along with Senator Smith, introduce the Money Follows the Person Act of 2005. This legislation is needed to truly bring people with disabilities into the mainstream of society…

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Judd Gregg
Sen. Judd GreggR-NH · Mar 3, 2005

Mr. President, today I am pleased to be joined by Senators Kennedy, Mikulski, Harkin, Bingaman, Reed, Murray, Lincoln, Kerry and Durbin in introducing the Public Safety Employer-Employee Cooperation…

Jack Reed
Sen. Jack ReedD-RI · Mar 3, 2005

Mr. President, I am pleased to be joined today by Senators Dodd, Kennedy, and Murray in once again introducing the Child Care Quality Incentive Act, which seeks to redouble our child care efforts and…

Frank R. Lautenberg
Sen. Frank R. LautenbergD-NJ · Mar 3, 2005

Mr. President, the tragic attacks of September 11, 2001 reminded us that police are heroes who risk their lives to protect us. That's why it's so outrageous that a gun manufacturer would design and…

Ken Salazar
Sen. Ken SalazarD-CO · Mar 3, 2005

Mr. President, I rise to introduce a simple piece of legislation. The idea underlying this bill is simple: words matter. How we characterize what we do sends a message, and nowhere is that more clear…

Kay Bailey Hutchison
Sen. Kay Bailey HutchisonR-TX · Mar 3, 2005

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record. Mr. President, I rise today to offer a bill that is vital for water conservation in my home State of Texas.…

Jon Kyl
Sen. Jon KylR-AZ · Mar 3, 2005

Mr. President, I am pleased to join today with Senator McCain to introduce the Yuma Crossing National Heritage Area Boundary Adjustment Act. This legislation would amend the Yuma Crossing National…

Chuck Hagel
Sen. Chuck HagelR-NE · Mar 3, 2005

Mr. President, I rise today with Senator Durbin to introduce the Public Health Preparedness Workforce Development Act of 2005. This legislation aims to increase the pipeline of qualified public…

Jim DeMint
Sen. Jim DeMintR-SC · Mar 3, 2005

Mr. President, I rise today to reintroduce ``Holly's Law,'' a bill that would suspend FDA's approval of RU-486 and direct the GAO to conduct an independent review of the process used by the FDA to…

Jim DeMint
Sen. Jim DeMintR-SC · Mar 3, 2005

Mr. President, I rise today to reintroduce ``Holly's Law,'' a bill that would suspend FDA's approval of RU-486 and direct the GAO to conduct an independent review of the process used by the FDA to…

Bill Text

Latest available legislative text

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Introduced in SenateIssued March 3, 2005

II

109th CONGRESS

1st Session

S. 511

IN THE SENATE OF THE UNITED STATES

March 3, 2005

Mr. DeMint (for himself, Mr. Allen, Mr. Brownback, Mr. Coburn, Mr. Ensign, Mr. Enzi, Mr. Inhofe, Mr. Santorum, and Mr. Vitter) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To provide that the approved application under the Federal Food, Drug, and Cosmetic Act for the drug commonly known as RU–486 is deemed to have been withdrawn, to provide for the review by the Comptroller General of the United States of the process by which the Food and Drug Administration approved such drug, and for other purposes.

1.

Short title

This Act may be cited as the RU–486 Suspension and Review Act of 2005.

2.

Finding

Congress finds that the use of the drug mifepristone (marketed as Mifeprex, and commonly known as RU–486) in conjunction with the off-label use of misoprostol to chemically induce abortion has caused a significant number of deaths, near deaths, and adverse reactions.

3.

Suspension of approval of drug commonly known as ru–486; review and report by government accountability office

(a)

In general

Effective on the date that is 15 days after the date of the enactment of this Act:

(1)

The approved application under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) for the drug mifepristone (marketed as Mifeprex, and commonly known as RU–486) is deemed to have been withdrawn under section 505(e) of such Act (21 U.S.C. 355(e)).

(2)

For purposes of sections 301(d) and 304 of such Act (21 U.S.C. 331(d) and 334), the introduction or delivery for introduction of such drug into interstate commerce shall be considered a violation of section 505 of such Act.

(3)

The drug misoprostol shall be considered misbranded for purposes of sections 301 and 304 of such Act if the drug bears labeling providing that the drug may be used for the medical termination of intrauterine pregnancy or that the drug may be used in conjunction with another drug for the medical termination of intrauterine pregnancy.

(b)

Review and report by government accountability office

(1)

In general

The Comptroller General of the United States shall review the process by which the Food and Drug Administration approved mifepristone under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and shall determine whether such approval was provided in accordance with such section. The Secretary of Health and Human Services shall ensure that the Comptroller General has full access to all information possessed by the Department of Health and Human Services that relates to such process.

(2)

Report

Not later than 180 days after the date of the enactment of this Act, the Comptroller General of the United States shall complete the review under paragraph (1) and submit to Congress and the Secretary of Health and Human Services a report that provides the findings of the review.

(c)

Contingent reinstatement of approval of drug

If the report under subsection (b) includes a determination by the Comptroller General of the United States that the approval by the Food and Drug Administration of mifepristone was provided in accordance with section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), the Secretary of Health and Human Services shall publish such statement in the Federal Register. Effective upon the expiration of 30 days after such publication, subsection (a) shall cease to have any legal effect.