Tag Archives: Food & Drug Administration

Black History, ~ FDA/USDA ~~ Alerts & Safety

CONGRESS: the Republican led House – back on 6/25 – the Senate will consider S.1940,Flood Insurance bill ,S.3187FDA bill,


  • Convenes: 2:00pmET June 25, 2012
  • Following the prayer and pledge, the Senate will resume consideration of the motion to proceed to S.1940, the Flood Insurance bill, post-cloture.
  • At a time to be determined but prior to 5:30pm on Monday, the motion to proceed to S.1940 will be adopted.
  • As a reminder to all Senators, cloture was filed on the motion to concur in the House message to accompany S.3187, the FDA bill on Thursday, June 21st.   As a result, there will be a roll call vote on the motion to invoke cloture on the motion to concur in the House message to accompany S.3187 at 5:30pm on Monday.

——————————————————————————————————————-

NEXT SESSION in the House is at  2:00 p.m. on June 25, 2012

~ politics petitions pollution and pop culture

What does $700 million get you?


Union of Concerned Scientists

What are pharmaceutical, biotech, and medical device companies trying to buy with $700,000,000? Massive influence with our government.

Don’t allow science to take a back seat to the financial interests of corporations! Urge the FDA to protect the American people from unsafe food, drugs, and medical devices by protecting science from corporate interference.

click here to take action

That’s the amount of money these companies spent over the last three years lobbying Congress and the Executive Branch, which includes the Food and Drug Administration (FDA). And now, with negotiations underway on legislation that will govern how the FDA approves and monitors prescription drugs and medical products, it’s clear that all that money has bought the industry a lot of influence with our legislators.

We can’t allow science to take a back seat to the financial interests of corporations—especially when our lives are on the line.
We have seen many concerted efforts from industry lobbyists to roll back key safeguards at the FDA that protect science from corporate interference. The FDA’s foremost priority is to protect the American people from unsafe food, drugs, and medical devices. That requires the agency use the best available science when determining whether products are safe or not.

It’s time we remind the FDA to put safety first.
Take Action Today!

Sincerely, Michael Halpern Michael Halpern Program Manager UCS Scientific Integrity Program
P.S. Don’t Forget: Give to the Union of Concerned Scientists today and your gift will go twice as far—helping to challenge attacks on science and stand up to corporate-sponsored misinformation.

Black History, ~ FDA/USDA ~~ Alerts & Safety

CONGRESS: the Republican led House back 5/25 – The Senate considers S.3187,FDA user fees – S.2343,Stop Student Loan Hike & S.2366,Interest Rate Reduction Act


the Senate Convenes: 9:30amET May 24, 2012

  • Following the prayer and pledge, the Senate will resume consideration of S.3187, the FDA user fees legislation.
  • The amendments below are the only remaining amendments in order to the bill. At 2:00pm, all debate time will be considered expired and the Senate will vote in relation to the amendments listed below and on passage of the bill, as amended. There will be 2 minutes of debate prior to each vote. All votes after the first vote will be 10 minutes in duration.
  • McConnell, or his designee, amendment, which is identical to the text of S.2366, the Interest Rate Reduction Act (60-vote threshold) and
  • Passage of S.2343, as amended, if amended (60-vote threshold).
  • Therefore, Senators should expect up to 12 roll call votes to begin at around 2:00pm on Thursday. Senator Reid announced the votes could begin earlier if debate is concluded prior to 2:00pm.

The following amendments have been considered to S.3187, the FDA user fees bill:

  • Harkin-Enzi amendment #2122 (substitute); agreed to by unanimous consent
  • Cardin amendment #2125 (health benefits/risks); agreed to by unanimous consent
  • Cardin amendment #2141 (FDA report-small business); agreed to by unanimous consent
  • Grassley amendment #2121 (whistleblower protections III); agreed to by unanimous consent
  • Grassley amendment #2129 (GAO report – clinical trials)
  • Manchin amendment #2151, as modified (reclassification of hydrocodone under Controlled Substances Act); agreed to by unanimous consent
  • Reed amendment #2126 (Sunscreen testing/labeling); agreed to by unanimous consent
  • Leahy amendment #2142, as modified (FOIA); agreed to by unanimous consent
  • Portman amendment #2145, as modified (Rx drug monitoring); agreed to by unanimous consent
  • Coburn amendment #2131 (drug application review process); agreed to by unanimous consent
  • Coburn amendment #2132 (FDA employee performance standards); withdrawn
  • Portman amendment #2146, as modified (Synthetic drugs – controlled substances); agreed to by voice vote
  • Bingaman amendment #2111 (generic filings) (60-vote threshold); Not agreed to: 28-67
  • Murkowski amendment #2108 (genetically engineered salmon); Not Agreed To: 46-50
  • Paul amendment #2143 (supplements); Tabled: 78-15
  • McCain amendment #2107 (drug reimportation); Not Agreed To: 43-54
  • Sanders amendment #2109 (criminal fraud/exclusivity); Not Agreed To: 9-88
  • Burr amendment #2130 (Congress – user fee negotiations); Withdrawn
  • Durbin amendment #2127 (dietary supplements); Tabled: 77-20

There is a strong effort have 2 votes at 12:15pm, break for the DPCC lunch and then resume voting at 2:00pm. We hope to vote in relation to Bingaman amendment #2111 and Murkowski amendment #2108 before lunch.

The following amendments were agreed to by consent:

– Leahy amendment #2142, as modified;

– Portman amendment #2145, as modified; and

– Coburn amendment #2131.

Coburn amendment #2132 was withdrawn.

Portman amendment #2146, as modified, was agreed to by voice vote.

Today’s votes include:

– Bingaman amendment #2111 (generic filings) (60-vote threshold);

– McCain amendment #2107 (reimportation) (60-vote threshold);

– Sanders amendment #2109 (criminal fraud/exclusivity) (60-vote threshold);

– Murkowski amendment #2108 (genetically engineered salmon) (60-vote threshold);

– Durbin amendment #2127 (dietary supplements);

– Paul amendment #2143 (supplements);

– Burr amendment #2130 (Congress – user fee negotiations);

– Passage of S.3187, as amended

–up to 10 minutes for debate–

– McConnell, or his designee, amendment, which is identical to the text of S.2366, the Interest Rate Reduction Act (60-vote threshold) and

– Passage of S.2343, as amended, if amended (60-vote threshold).

12:08pm The Senate began a roll call vote on the Bingaman amendment #2111 (generic filings) (60-vote threshold); Not Agreed to: 28-67

12:36pm The Senate began a roll call vote on the Murkowski amendment #2108 (genetically engineered salmon) (60-vote threshold); Not Agreed to: 46-50

There will be 2 roll call votes at 12:05pm in relation to the following amendments to S.3187, the FDA bill:

– Bingaman amendment #2111;

– Murkowski amendment #2108; and

– Paul amendment #2143 (supplements);

– McCain amendment #2107 (reimportation) (60-vote threshold);

– Sanders amendment #2109 (criminal fraud/exclusivity) (60-vote threshold);

– Durbin amendment #2127 (dietary supplements);

– Burr amendment #2130 (Congress – user fee negotiations);

– Passage of S.3187, as amended

–up to 10 minutes for debate–

– McConnell, or his designee, amendment, which is identical to the text of S.2366, the Interest Rate Reduction Act (60-vote threshold) and

– Passage of S.2343, as amended, if amended (60-vote threshold).

1:58pm The Senate began a roll call vote on Harkin motion to table Paul amendment #2143; Tabled: 78-15

2:19pm The Senate began a roll call vote on McCain amendment #2107 (Reimportation); Not Agreed To: 43-54

2:39pm The Senate began a roll call vote on Sanders amendment #2109 (criminal fraud/exclusivity); Not Agreed To: 9-88

2:57pm The Senate began a roll call vote on the Harkin motion to table Durbin amendment #2127 (dietary supplements); Tabled: 77-20

3:15pm The Senate began a roll call vote on passage of S.3187, the FDA bill; Passed: 96-1

3:46pm The Senate began a roll call vote on Alexander amendment #2153 (student loans) to S.2343, the Stop Student Loan Interest Rate Hike Act; Not Agreed to: 34-62-1 (present)

4:02pm The Senate began a roll call vote on passage of S.2343, the Stop Student Loan Interest Rate Hike Act; Not Passed: 51-43-1(present)

There will be no further roll call votes during Thursday’s session of the Senate.

By unanimous consent, the Senate passed H.R.5740, Flood Insurance extension, as amended by Johnson (SD) substitute.

The Johnson (SD) substitute amendment is a 60-day extension and includes language regarding second homes.

4:30pm Senator Reid moved to proceed to S.3220, a bill to amend the Fair Labor Standards Act of 1938 to provide more effective remedies to victims of discrimination in the payment of wages on the basis of sex, and for other purposes., and filed cloture on the motion. The cloture vote on the motion to proceed will occur at 2:15pm on Tuesday, June 5th. There will be a vote Monday night (around 5:30pm) on a judge.

Senator Reid asked unanimous consent that the Senate proceed to the consideration of Calendar #398, H.R.5652; that all after the enacting clause be stricken and the language of S.1925, the Violence Against Women Act Reauthorization, as passed by the Senate on April 26th by a vote of 68-31, be inserted in lieu thereof; that the Senate insist on its amendment, request a conference with the House on the disagreeing votes of the two Houses; and the Chair be authorized to appoint conferees on the part of the Senate; with all of the above occurring with no intervening action or debate.

Senator McConnell objected and asked the following consent:

That the Senate proceed to the consideration of H.R.4970, the House passed Violence Against Women Reauthorization Act; that all after the enacting clause be stricken, the text of the Senate passed VAWA bill, S.1925 with a modification that strikes sections 805 and 810 related to the immigration issue; the bill be read three times and passed; the Senate insist on its amendment, request a conference with the House, and the Chair be authorized to appoint conferees on the part of the Senate with a ratio agreed to by both leaders.

Senator Reid objected.

WRAP UP

ROLL CALL VOTES

1) Bingaman amendment #2111 (generic filings) (60-vote threshold) to S.3187, the FDA user fees bill; Not Agreed to: 28-67

2) Murkowski amendment #2108 (genetically engineered salmon) (60-vote threshold); Not Agreed to: 46-50

3) Harkin motion to table Paul amendment #2143; Tabled: 78-15

4) McCain amendment #2107 (Reimportation) (60-vote threshold); Not Agreed To: 43-54

5) Sanders amendment #2109 (criminal fraud/exclusivity) (60-vote threshold); Not Agreed To: 9-88

6) Harkin motion to table Durbin amendment #2127 (dietary supplements); Tabled: 77-20

7) Passage of S.3187, the FDA user fees bill, as amended; Passed: 96-1

8) Alexander amendment #2153 (student loans) to S.2343, the Stop Student Loan Interest Rate Hike Act (60-vote threshold); Not Agreed to: 34-62-1 (present)

9) Passage of S.2343, the Stop Student Loan Interest Rate Hike Act (60-vote threshold); Not Passed: 51-43-1(present)

LEGISLATIVE ITEMS

Passed S.414, International Protecting Girls by Preventing Child Marriage Act of 2011 by voice vote.

Passed S.739, a bill to authorize the Architect of the Capitol (AOC) to establish battery recharging stations in parking areas under the jurisdiction of the Senate at no net cost to the Federal Government with a Levin amendment.

Discharged the Agriculture committee and passed H.R.2947, a bill to provide for the release of the reversionary interest held by the United States in certain land conveyed by the United States in 1950 for the establishment of an airport in Cook County, Minnesota.

Discharged Judiciary and Passed H.R.3992, a bill to allow otherwise eligible Israeli nationals to receive E-2 nonimmigrant visas if similarly situated United States nationals are eligible for similar nonimmigrant status in Israel.

Discharged Judiciary and adopted S.Res.455, designating June 27, 2012, as “National Post-Traumatic Stress Disorder Awareness Day”.

Adopted S.Res.475, Relating to the death of the Honorable E. James Abdnor, former United States Senator and Congressman from the State of South Dakota.

Began the Rule 14 process of S.J.Res.41, expressing the sense of Congress regarding the nuclear programs of Iran (Graham and others).

EXECUTIVE ITEMS

Discharged the Foreign Relations committee and confirmed PN1520, David J. Lane, of Florida, for the rank of Ambassador during his tenure of service as U.S. Representative to the United Nations Agencies for Food and Agriculture

Discharged the HELP committee and confirmed PN1565, 16 Public Health Service nominations received by the Senate on April 26, 2012, beginning with Joseph R. Fontana, and ending with Joy A. Mobley; and PN1679, 114 Public Health Service nominations received by the Senate on May 15, 2012, beginning with Mary J. Choi, and ending with Meghan M. Zomorodi.

Confirmed the following items:

all nominations placed on the Secretary’s desk in the Air Force, Army, Foreign Service, Marine Corps, and Navy;

INTERNATIONAL BANK FOR RECONSTRUCTION AND DEVELOPMENT

Executive Calendar #640 Sara Margalit Aviel—to be United States Alternate Executive Director of the International Bank for Reconstruction and Development for a term of two years by voice vote

CORPORATION FOR NATIONAL AND COMMUNITY SERVICE

Executive Calendar #261 Matthew Francis McCabe — to be a Member of the Board of Directors of the Corporation for National and Community Service

SECURITIES INVESTOR PROTECTION CORPORATION

Executive Calendar #338 Anthony Frank D’Agostino – to be a Director of the Securities Investor Protection Corporation

Executive Calendar #339 Anthony Frank D’Agostino – to be a Director of the Securities Investor Protection Corporation (Reappointment)

Executive Calendar #340 Gregory Karawan – to be a Director of the Securities Investor Protection Corporation

THE JUDICIARY

Executive Calendar #665 Roy Wallace McLeese III—to be an Associate Judge of the District of Columbia Court of Appeals for the term of fifteen years

DEPARTMENT OF ENERGY

Executive Calendar #678 Adam E. Sieminski—to be Administrator of the Energy Information Administration

FEDERAL ENERGY REGULATORY COMMISSION

Executive Calendar #679 Anthony T. Clark—to be a Member of the Federal Energy Regulatory Commission for the term expiring June 30, 2016

Executive Calendar #680 John Robert Norris—to be a Member of the Federal Energy Regulatory Commission for the term expiring June 30, 2017. (Reappointment)

THE JUDICIARY

Executive Calendar #681 Margaret Bartley—to be a Judge of the United States Court of Appeals for Veterans Claims for the term of fifteen years

Executive Calendar #682 Coral Wong Pietsch—to be a Judge of the United States Court of Appeals for Veterans Claims for the term of fifteen years

DEPARTMENT OF STATE

Executive Calendar #706 Michael A. Raynor—to be Ambassador Extraordinary and Plenipotentiary of the United States of America to the Republic of Benin.

Executive Calendar #707 Scott H. DeLisi—to be Ambassador Extraordinary and Plenipotentiary of the United States of America to the Republic of Uganda.

Executive Calendar #708 Makila James—to be Ambassador Extraordinary and Plenipotentiary of the United States of America to the Kingdom of Swaziland.

DEPARTMENT OF DEFENSE

Executive Calendar #710 Jessica Lynn Wright—to be an Assistant Secretary of Defense

Executive Calendar #711 James N. Miller, Jr.—to be Under Secretary of Defense for Policy

Executive Calendar #712 Frank Kendall III—to be Under Secretary of Defense for Acquisition, Technology, and Logistics

Executive Calendar #713 Erin C. Conaton—to be Under Secretary of Defense for Personnel and Readiness

Executive Calendar #715 Derek H. Chollet—to be an Assistant Secretary of Defense

Executive Calendar #716 Kathleen H. Hicks—to be a Principal Deputy Under Secretary of Defense

Executive Office of the President

Executive Calendar #717 Joseph G. Jordan, of Massachusetts, to be Administrator for Federal Procurement Policy

DEPARTMENT OF DEFENSE

Executive Calendar #725 Katharina G. McFarland—to be an Assistant Secretary of Defense

AIR FORCE

Executive Calendar #727 to be Lieutenant General: Maj. Gen. Michael D. Dubie

Executive Calendar #728 to be Brigadier General: Col. Bobby V. Page

Executive Calendar #729 to be General: Gen. Philip M. Breedlove

Executive Calendar #730 to be General: Lt. Gen. Larry O. Spencer

Executive Calendar #731 to be Lieutenant General: Maj. Gen. Noel T. Jones

Executive Calendar #732 to be Brigadier General: Col. Wayne A. Zimmet

ARMY

Executive Calendar #733 to be Lieutenant General: Maj. Gen. Theodore C. Nicholas

Executive Calendar #734 to be Brigadier General: Col. Francisco A. Espaillat

Executive Calendar #735 to be Major General: Brig. Gen. William R. Phillips, II

Executive Calendar #736 to be Major General:

Brigadier General Leslie J. Carroll;

Brigadier General Bryan R. Kelly;

Brigadier General Peter S. Lennon;

Brigadier General Gary A. Medvigy;

Brigadier General David W. Puster;

Brigadier General Megan P. Tatu;

Brigadier General Daniel L. York; and

Brigadier General James V. Young, Jr.

to be Brigadier General:

Colonel Douglas F. Anderson;

Colonel Danny C. Baldwin;

Colonel William P. Barriage;

Colonel Leanne P. Burch;

Colonel Mitchell R. Chitwood;

Colonel Stephen K. Curda;

Colonel Arlan M. Deblieck;

Colonel Chris R. Gentry;

Colonel Norman B. Green;

Colonel Lewis G. Irwin;

Colonel Phillip S. Jolly;

Colonel Robert A. Karmazin;

Colonel Troy D. Kok;

Colonel William S. Lee;

Colonel Tammy S. Smith; and

Colonel Michael S. Tuomey

Executive Calendar #737 to be Lieutenant General: Lt. Gen. Michael T. Flynn

MARINE CORPS

Executive Calendar #738 to be Lieutenant General: Lt. Gen. Thomas D. Waldhauser

Executive Calendar #739 to be Lieutenant General: Maj. Gen. Jon M. Davis

Executive Calendar #740 to be Lieutenant General: Lt. Gen. Robert E. Schmidle, Jr.

Executive Calendar #741 to be Lieutenant General: Lt. Gen. Terry G. Robling

Executive Calendar #742 to be Brigadier General: Col. Burke W. Whitman

Executive Calendar #743 to be Major General: Brig. Gen. James M. Lariviere

Executive Calendar #744 to be Lieutenant General: Lt. Gen. John M. Paxton, Jr.

Executive Calendar #745 to be Lieutenant General: Maj. Gen. John A. Toolan, Jr.

Executive Calendar #746 to be Brigadier General: Col. Paul K. Lebidine

Executive Calendar #747 to be Lieutenant General: Lt. Gen. Robert B. Neller

NAVY

Executive Calendar #748 to be Admiral: Vice Adm. William E. Gortney

Executive Calendar #749 to be Vice Admiral: Rear Adm. Kurt W. Tidd

Executive Calendar #750 to be Vice Admiral: Vice Adm. David H. Buss

Executive Calendar #751 to be Vice Admiral: Rear Adm. Michelle J. Howard

Executive Calendar #752 to be Vice Admiral: Rear Adm. Thomas H. Copeman, III

Executive Calendar #753 to be Vice Admiral: Vice Adm. Richard W. Hunt

Executive Calendar #754 to be Rear Admiral (lower half): Capt. John F. Kirby

Executive Calendar #755 to be Rear Admiral (lower half): Capt. Brian B. Brown

JAMES MADISON MEMORIAL FELLOWSHIP FOUNDATION

Executive Calendar #756 Drew R. McCoy—to be a Member of the Board of Trustees of the James Madison Memorial Fellowship Foundation for a term expiring January 27, 2016 (Reappointment)

Executive Calendar #757 Pauline R. Maier—to be a Member of the Board of Trustees of the James Madison Memorial Fellowship Foundation for a term expiring November 17, 2017

UNITED STATES PAROLE COMMISSION

Executive Calendar #758 Charles Thomas Massarone, of Kentucky, to be a Commissioner of the United States Parole Commission for a term of six years.

——————————————————————————————————————

The next meeting is scheduled for 10:00 a.m. on May 25, 2012.

House Hearings

10:05 A.M. – The Speaker announced that the House do now adjourn. The next meeting is scheduled for 10:00 a.m. on May 25, 2012.
10:05 A.M. – The Speaker announced approval of the Journal.  Pursuant to clause 1, rule I, the Journal stands approved.
10:05 A.M. – PLEDGE OF ALLEGIANCE TO THE FLAG – The Chair led the House in reciting the Pledge of Allegiance to the Flag.
10:04 A.M. – Today’s prayer was offered by Monsignor Stephen Rossetti, Associate Professor, The Catholic University of America, Washington, DC.
10:02 A.M. – The Speaker designated the Honorable Roscoe G. Bartlett to act as Speaker pro tempore for today.
Black History, ~ Recent Post

CONGRESS: the Republican led House keeps taking days off – the Senate considers S.3187,FDA user fees


the Senate Convened at 9:30amET May 23, 2012

  • Following the prayer and pledge, the Majority Leader will be recognized. It is his intention to resume consideration of the motion to proceed to S.3187, the FDA user fees legislation.
  • Following the remarks of the Majority Leader and the Republican Leader, the first hour will be equally divided and controlled between the two sides with the Republicans controlling the first half and the Majority controlling the final half.
  • At 11:00am, the motion to proceed to S.3187 will be adopted, the Harkin-Enzi substitute amendment will be agreed to and considered original text for the purposes of further amendment. The Majority Leader will then be recognized.
  • Additionally, the Majority will control the time from 1:00pm until 2:00pm.
  • We are working on an agreement for amendments to the FDA user fees legislation.  We hope an agreement can be reached without filing cloture on the bill.  Senators will be notified if an agreement is reached and when votes are scheduled.

By consent, the previous order to adopt them motion to proceed to S.3187, the FDA bill, has been delayed until 12:30pm today. The Majority Leader will be recognized prior to adoption of the motion to proceed.

By consent, the previous order to adopt them motion to proceed to S.3187, the FDA bill, has been delayed until 2:15pm today. The Majority Leader will be recognized prior to adoption of the motion to proceed. As a reminder, the previous order is to adopt the motion to proceed and agree to the Harkin-Enzi substitute amendment by consent.

The Senate has reached an agreement to limit amendments to S.3187, the FDA bill, to those amendments listed below. No other amendments are in order. There will be 30 minutes for debate on each amendment, except for the McCain amendment, and 60 minutes on the bill, both equally divided in the usual form. There will be 2 hours equally divided on the McCain amendment #2107.

At 2pm on Thursday, May 24, all debate time will be considered expired and the Senate will proceed to vote in relation to the amendments in the order listed. Amendments are subject to a majority vote except where noted with a 60 affirmative vote thresholds. There will be 2 minutes for debate prior to each vote. All votes after the first vote will be 10 minutes in duration. No motions or points of order are in order to the amendment or the bill other than budget points of order and the applicable motions to waive or motions to table. Upon disposition of the amendments, the Senate will proceed to vote on passage of S.3187, as amended.

Further upon disposition of the FDA bill, the Senate will proceed to the consideration of S.2343, the Student Loan interest rate bill. There will be 10 minutes for debate prior to a series of 2 roll call votes. The first, in relation to McConnell, or designee, amendment, which is identical to the text of S.2366, and then on passage of S.2343, as amended, if amended. The amendment and bill are subject to 60-vote thresholds. No motions or points of order are in order to the amendment or the bill other than budget points of order and the applicable motions to waive. If the bill does not achieve 60 affirmative votes, S.2343 will be returned to the Calendar.  Senator Reid’s previously entered motion to reconsider the failed cloture vote is withdrawn.

Amendments in order to the FDA bill:

– Bingaman #2111 (generic filings) (60-vote threshold)**;

– McCain #2107 (reimportation) (60-vote threshold)**;

– Sanders #2109 (criminal fraud/exclusivity) (60-vote threshold)**;

– Murkowski #2108 (genetically engineered salmon) (60-vote threshold)**;

– Cardin #2125 (health benefits/risks);

– Cardin #2141 (FDA report – small business);

– Grassley #2121 (whistleblower protections III);

– Grassley #2129 (GAO report – clinical trials);

– Manchin #2151, as modified [or new version??] (reclassifying hydrocodone under Controlled Substances Act)**;

– Portman #2146, as modified (Synthetic drugs – controlled substances);

– Portman #2145, as modified (Rx drug monitoring);

– Reed #2126 (Sunscreen testing/labeling); and

– Coburn #2132 (FDA employee performance standards)**;

– Coburn #2131 (Drug Application Review Process)**;

– Durbin #2127 (dietary supplements)**;

– Paul #2143 (supplements)]**;

– Burr #2130 (Congress – user fee negotiations)**.

** indicates the most likely targets for roll call votes.

The following amendments are pending to S.3187, the FDA user fees bill:

The following amendments have been considered to S.3187, the FDA user fees bill:

  • Harkin-Enzi amendment #2122 (substitute); agreed to by unanimous consent
  • Cardin amendment #2125 (health benefits/risks); agreed to by unanimous consent
  • Cardin amendment #2141 (FDA report-small business); agreed to by unanimous consent
  • Grassley amendment #2121 (whistleblower protections III); agreed to by unanimous consent
  • Grassley amendment #2129 (GAO report – clinical trials)
  • Manchin amendment #2151, as modified (reclassification of hydrocodone under Controlled Substances Act); agreed to by unanimous consent
  • Reed amendment #2126 (Sunscreen testing/labeling); agreed to by unanimous consent

WRAP UP

No ROLL CALL VOTES

LEGISLATIVE ITEMS

Discharged the Banking committee and passed S.2367, a bill to strike the word “lunatic” from Federal law, and for other purposes.

Passed H.R.4097, the John F. Kennedy Center Reauthorization Act of 2012.

Completed the Rule 14 process of S.3220, the Paycheck Fairness Act. (Mikulski and others)

Completed the Rule 14 process of S.3221, the Rewarding Achievement and Incentivizing Successful Employees Act. (Rubio and others)

No EXECUTIVE ITEMS

————————————————————————————————–

The next meeting is scheduled for 10:00 a.m. on May 25, 2012.

~ politics petitions pollution and pop culture

Tell Congress to fix … The medical-device safety bill

2 Comments

Today's consumer action:

Fix the Flaw!The medical-device safety bill is coming up for a major vote, and it still has a gaping loophole! Tell your Senators to Fix the Flaw!Take action

You wouldn’t buy a new car with a known safety defect. You’d expect the problem to be fixed first.

So why is Congress planning to let medical device manufacturers keep selling implants – from hip replacements to heart defibrillators to surgical mesh – without having them fix the safety flaw first?

Tell your Senators and Representative: Fix the Flaw!

This week the Senate could vote on the bill that sets safety standards for the medical device industry. Lobbyists have managed to keep this gaping safety loophole from being fixed in the bill, and we need consumers to speak out today before it’s too late.

Manufacturers love the loophole because they can put an implant on the market just by showing that it’s ‘substantially equivalent’ to one already approved – even if the implant they’re modeling it on was recalled for safety problems! And the FDA can’t make the company prove they’ve fixed the flaw or do clinical safety testing before the device is sold to you!

The consequences are serious. Tens of thousands of women have various vaginal mesh implants inside them based on a 1999 recalled product. Last year the FDA warned about bleeding, infections and organ perforation from the mesh deteriorating, and many women require multiple surgeries to repair the damage. The FDA should have the authority to demand flaws like these be fixed before allowing the devices to be sold.

Congress: Fix the Flaw with medical devices, and hold industry responsible for safety!

It’s important you get your Senators’ attention on this matter, or the loophole might just slip quietly through. Consumers’ emails have already made the safety bills stronger, so please forward this to others so they can add their voice to this critical issue.

Sincerely,
Lisa McGiffert, SafePatientProject.org