Tag Archives: Food And Drug Administration

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


the Senate Convenes: 10:00amET May 22, 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 Calendar #400, 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 Majority controlling the first half and the Republicans controlling the final half.
  • The Senate will recess from 12:30pm until 2:15pm to allow for the weekly caucus meetings.
  • At 2:15pm, 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. Senators will be notified when votes are scheduled.

12:15pm Senator Vitter asked unanimous consent that the Senate take up and pass S.577, a bill to eliminate the child tax credit for U.S. citizen children of immigrant parents. Senator Reid objected.

Below you will find the unofficial transcript of Senator Reid’s response to Senator Vitter

2:30pm The previous order to adopt the motion to proceed S.3187, the FDA bill, at 2:15pm has been delayed until 4pm, with all other provisions under the previous order remaining in effect at that time.

4:13pm By consent, Senator Reid has delayed the execution of the order to adopt the motion to proceed to S.3187, the FDA bill, until 11:00am tomorrow, Wednesday, May 23.

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

WRAP UP

No ROLL CALL VOTES

LEGISLATIVE ITEMS

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

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

No EXECUTIVE ITEMS

————————————————————————————————————

CURRENT HOUSE FLOOR PROCEEDINGS

LEGISLATIVE DAY OF MAY 22, 2012

112TH CONGRESS – SECOND SESSION

CURRENT HOUSE FLOOR PROCEEDINGSLEGISLATIVE DAY OF MAY 22, 2012 112TH CONGRESS – SECOND SESSION en-usPursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.Tue, 22 May 2012 14:00:03 EDTYes10:05:38 A.M. -The Speaker announced that the House do now adjourn. The next meeting is scheduled for 10:00 a.m. on May 25, 2012.10:05:36 A.M. -The Speaker announced approval of the Journal. Pursuant to clause 1, rule I, the Journal stands approved.10:05:11 A.M. -PLEDGE OF ALLEGIANCE TO THE FLAG – The Chair led the House in reciting the Pledge of Allegiance to the Flag.10:04:18 A.M. -Today’s prayer was offered by Monsignor Stephen Rossetti, Associate Professor, The Catholic University of America, Washington, DC.10:02:45 A.M. -The Speaker designated the Honorable Roscoe G. Bartlett to act as Speaker pro tempore for today.10:00:34 A.M. -The House convened, starting a new legislative day.

House Hearings

5/30
4:00 pm
Hearing: Purchasing Perspective: VA’s Prosthetics ParadoxCommittee on Veterans’ Affairs: Subcommittee on Oversight and Investigations 5/31
10:15 am
Hearing: Reviewing the Implementation of Major Provisions of the VOW to Hire Heroes Act of 2011Committee on Veterans’ Affairs: Full Committee 6/6
10:30 am
Hearing: Through the Looking Glass: Return to PPVCommittee on Veterans’ Affairs: 6/6
2:00 pm
Hearing: Pending LegislationCommittee on Veterans’ Affairs: Subcommittee on Disability Assistance and Memorial Affairs

Healthy Women’s Action Kit Featured in “Dear Abby”


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Obama: Cut FDA ties to Monsanto


Below is an email from Frederick Ravid, a MoveOn member who created a petition at SignOn.org that is spreading like wildfire on the Internet, and we think you should check it out. If you have concerns or feedback about this petition, click here.


Dear MoveOn member,

President Obama appointed former Monsanto vice president and lobbyist Michael Taylor as senior advisor to the Food and Drug Administration commissioner.

This is a classic example of the fox guarding the henhouse. President Obama should isolate the FDA from corporate influence by asking Taylor to step down immediately.

That’s why I created a petition to President Obama on SignOn.org. Click here to add your name, and then pass it along to your friends:

http://www.moveon.org/r?r=269891&id=35269-21087915-c0s4_0x&t=2

The petition says:

President Obama, I oppose your appointment of Michael Taylor, a former VP and lobbyist for Monsanto, the widely criticized genetically modified (GM) food multinational, as senior advisor to the commissioner at the FDA. Taylor is the same person who as a high ranking official at the FDA in the 1990s promoted allowing genetically modified organisms into the U.S. food supply without undergoing a single test to determine their safety or risks. This is a travesty.

Taylor was in charge of policy for Monsanto’s now-discredited GM bovine growth hormone (rBGH), which is opposed by many medical and hospital organizations. It was Michael Taylor who pursued a policy that milk from rBGH-treated cows should not be labeled with disclosures. Michael Taylor and Monsanto do not belong in our government.

President Obama, Monsanto has been seen as a foe to family-based agriculture, the backbone of America, by introducing dangerous changes to plants and animals and by using strong-arm legal tactics against farmers for decades. Naturally occurring plant and animal species are permanently threatened by the introduction of DNA and hormonal modification, Monsanto’s core businesses.

FDA scientists once regarded genetic modification of the food supply as the single most radical and potentially dangerous threat to public health in history. As early as the 1991, a body of scientific research began to form which now includes articles in over 600 journals. As a whole, these offer scientific evidence that GM foods, hormones, and related pesticides are the root cause for the increase of many serious diseases in the U.S. Since GM foods were introduced, diagnosis of multiple chronic illnesses in the U.S. has skyrocketed. These illnesses include changes in major organs and in hormonal, immune, digestive, and reproductive systems. These modifications to foods and food production may also be contributors to colon, breast, lymphatic, and prostate cancers.

Experts are discouraged that regulators and GM companies systematically overlook potential side effects of GM. Monsanto’s objective to use biotechnology to change the world’s food supply is the opposite policy direction your administration should pursue. Your legacy of supporting Monsanto to have free rein in U.S. food policy is a nightmare scenario that is against the interest of all Americans and world citizens.

Will you sign the petition? Click here to add your name, and then pass it along to your friends:

http://www.moveon.org/r?r=269891&id=35269-21087915-c0s4_0x&t=3

Thanks!

–Frederick Ravid

The text above was written by Frederick Ravid, not by MoveOn staff, and MoveOn is not responsible for the content. This email was sent through MoveOn’s secure system, and your information has been kept private.

News we can all use, from… Health Human Services –Secretary K.Sebelius: Contraceptives,LIHEAP and MORE!


FOR IMMEDIATE RELEASE January 20, 2012 Contact: HHS Press Office (202) 690-6343

A statement by U.S. Department of Health and Human Services Secretary Kathleen Sebelius

In August 2011, the Department of Health and Human Services issued an interim final rule that will require most health insurance plans to cover preventive services for women including recommended contraceptive services without charging a co-pay, co-insurance or a deductible.  The rule allows certain non-profit religious employers that offer insurance to their employees the choice of whether or not to cover contraceptive services. Today the department is announcing that the final rule on preventive health services will ensure that women with health insurance coverage will have access to the full range of the Institute of Medicine’s recommended preventive services, including all FDA -approved forms of contraception.  Women will not have to forego these services because of expensive co-pays or deductibles, or because an insurance plan doesn’t include contraceptive services. This rule is consistent with the laws in a majority of states which already require contraception coverage in health plans, and includes the exemption in the interim final rule allowing certain religious organizations not to provide contraception coverage. Beginning August 1, 2012, most new and renewed health plans will be required to cover these services without cost sharing for women across the country.

After evaluating comments, we have decided to add an additional element to the final rule. Nonprofit employers who, based on religious beliefs, do not currently provide contraceptive coverage in their insurance plan, will be provided an additional year, until August 1, 2013, to comply with the new law. Employers wishing to take advantage of the additional year must certify that they qualify for the delayed implementation. This additional year will allow these organizations more time and flexibility to adapt to this new rule.  We intend to require employers that do not offer coverage of contraceptive services to provide notice to employees, which will also state that contraceptive services are available at sites such as community health centers, public clinics, and hospitals with income-based support.  We will continue to work closely with religious groups during this transitional period to discuss their concerns.

Scientists have abundant evidence that birth control has significant health benefits for women and their families, it is documented to significantly reduce health costs, and is the most commonly taken drug in America by young and middle-aged women. This rule will provide women with greater access to contraception by requiring coverage and by prohibiting cost sharing.

This decision was made after very careful consideration, including the important concerns some have raised about religious liberty. I believe this proposal strikes the appropriate balance between respecting religious freedom and increasing access to important preventive services. The administration remains fully committed to its partnerships with faith-based organizations, which promote healthy communities and serve the common good.  And this final rule will have n

FOR IMMEDIATE RELEASE January 19, 2012 Contact: ACF Press Office (202) 401-9215

HHS releases more than $863 million to help low-income households with energy costs stay safe and healthy

The U.S. Department of Health and Human Services (HHS) is releasing more than $863 million today to grantees to help low-income households with their heating and other home energy costs under the Low Income Home Energy Assistance Program (LIHEAP). HHS is releasing the remaining funds, made available by the Consolidated Appropriation Act, 2012 (Public Law 112-74), to states, territories, tribes and the District of Columbia.

“This support is critical for families needing assistance to pay their home energy costs,” said George Sheldon, HHS acting assistant secretary for children and families. “We are releasing these funds today to help ease the burden for those vulnerable families and aid them in getting through the remaining winter months and the summer months ahead.”

LIHEAP assists low-income households, including families with children and seniors, with their home energy needs such as heating in the winter, cooling in the summer, and insulating their homes to make them more energy-efficient and to reduce their energy costs. The $863 million in regular block grant funds released today is in addition to the $2.6 billion released since October 2011. Including funds released today, grantees will receive a total of $3.4 billion in LIHEAP block funds for Fiscal Year 2012.

“Many Americans make difficult decisions whether it’s paying for rent, food and heating costs, which can add a real strain on families,” said Jeannie Chaffin, director for the Office of Community Services. “We are releasing these funds today to help as many families as possible get through this winter season safe and warm.”

For a complete list of additional funds available to grantees today please visit: http://www.acf.hhs.gov/news/press/2012/FY2012LIHEAP_GrossAlloc.html.

Individuals interested in applying for energy assistance should contact their local/state LIHEAP agency. For more information, go to: http://www.acf.hhs.gov/programs/ocs/liheap or http://www.acf.hhs.gov/programs/ocs/liheap/brochure/brochure.html.

January 18, 2012 New National Biodefense Science Board members will advise HHS Seven experts from outside the federal government will join the National Biodefense Science Board (NBSB), a federal advisory committee which provides expert advice and guidance on preventing, preparing for, and responding to adverse health effects of public health emergencies to the HHS Secretary and the HHS Assistant Secretary for Preparedness and Response (ASPR). The new members replace members whose 4-year terms expire Jan. 31.

January 13, 2012 Statement from Secretary Sebelius for Martin Luther King, Jr. Day – Jan. 2012 Today, as we honor the legacy of Dr. Martin Luther King Jr., we reflect on our own response to his call for justice. “Of all the forms of inequality,” Dr. King said, “injustice in health care is the most shocking and inhumane.”

January 12, 2012 Affordable Care Act holding insurers accountable for premium hikes | En Español Health insurance premium increases in five states have been deemed “unreasonable” by the U.S. Department of Health and Human Services, HHS Secretary Kathleen Sebelius announced today.

January 10, 2012 HHS commits nearly $1.8 million to health initiatives in Guatemala and to improving global human research protections | En Español The U.S. Department of Health and Human Services will invest approximately $1.8 million to increase its efforts to improve the treatment and prevention of HIV and other sexually transmitted diseases (STD) in Guatemala and to further strengthen ethical training on human research protections.

January 9, 2012 HHS launches first consumer health IT video challenge of 2012 The National Coordinator for Health Information Technology announced today a nationwide, open call for entries in the Healthy New Year Video Challenge, highlighting personal stories of patients and families using health technology to improve health.  The video challenge, launched by the Office of the National Coordinator for Health Information Technology (ONC), kicks off the first in a series of consumer video contests in 2012 as a way to engage consumers to integrate technology into their health care.

January 5, 2012 Affordable Care Act provision cuts red tape, saves up to $4.5 billion New standards for electronic funds transfers in health care, required by the Affordable Care Act, will reduce up to $4.5 billion off administrative costs for doctors and hospitals, private health plans, states, and other government health plans, over the next ten years, according to estimates included in new rules published today by the U.S. Department of Health and Human Services (HHS).

January 5, 2012 HHS’s Program Support Center closes Silver Spring, Md data center HHS’s Program Support Center (PSC) has closed its Silver Spring data center in support of the Federal Data Center Consolidation Initiative (FDCCI).  The Obama administration initiative seeks to eliminate waste by consolidating federal data centers that are no longer needed and pursue IT investments toward more efficient and secure computing platforms.

January 4, 2012 Final health IT innovators win funding for cancer treatment apps Innovative winners of an HHS public data and cancer challenge have created health IT applications that use public data and existing technology to help patients and health care professionals prevent, detect, diagnose and treat cancer.

Message from Nancy Brown on Enactment of Family Smoking Prevention and Tobacco Control Act- UPDATE!


An UPDATE

American
Heart Association CEO Nancy Brown Hails Progress in Smoke-Free Policies

Over the last decade, we have made steady progress in
protecting Americans from the deadly consequences of tobacco use with passage of
comprehensive smoke-free policies. But it’s too soon to rest on our laurels.
Twenty-five states and the District of Columbia have enacted smoke-free laws for
workplaces, bars and restaurants since 2000, according to the Centers for
Disease Control and Prevention (CDC), and if current trends continue, the nation
could be 100 percent smoke-free by 2020. However, nearly half of the country
still lacks comprehensive smoke-free laws, hampering efforts to reduce tobacco
use and smoking-related illnesses in the southern region of the country where
heart disease and stroke death rates remain high. Tobacco use is a major risk
factor for cardiovascular disease, the nation’s No. 1 killer. We must zero in on
those areas that continue to lag despite studies that show smoke-free policies
benefit public health and the local economy with lower health care
costs.

The CDC report, State Smoke-free Laws for Worksites, Restaurants,
and Bars – United States, 2000-2010, indicates approximately 88 million
Americans are still exposed to secondhand smoke and several states have
exemptions that put too many nonsmokers at risk. This remains a hurdle that must
be addressed with passage of strong legislation to close loopholes. Elected
officials, particularly those in the south, must do more to enact comprehensive
smoke-free laws and give citizens a greater opportunity to breathe clean
air.

For more information, visit the CDC
website
.

Today, we’re celebrating a monumental victory in the fight against heart disease and stroke. Representing the American Heart Association’s 22 million volunteers, supporters and dedicated staff, AHA President Dr. Timothy Gardner and I were thrilled to stand with President Obama at the White House as he signed the bipartisan Family Smoking Prevention and Tobacco Control Act. This legislation represents another huge step toward breaking the deadly cycle of tobacco addiction that leads to an increased risk of heart disease and stroke for millions of Americans.

This bill, which had tremendous support from Republicans and Democrats alike, will give the Food and Drug Administration (FDA) the clear authority to regulate the manufacturing, advertising and promotion of tobacco products in order to protect public health.  The bill also focuses on limiting advertising that targets our kids.  It is estimated that the legislation will result in an eleven percent decline in underage smoking over the next decade and will significantly reduce the annual $100 billion cost for tobacco-related illnesses in the U.S.


Why is this legislative victory so important?  Nearly one-third of cardiovascular disease deaths are linked to smoking, and tobacco use is the single most preventable cause of heart disease and stroke. For generations, tobacco companies lied to the public about the deadly dangers of tobacco use.  They lied about the addictiveness of nicotine.  They made misleading health claims about light and low-tar products.  And they shamelessly and aggressively marketed to children to attract new smokers.  These unconscionable practiceswill finally be reined in with effective government oversight of an industry that has placed profits above the health of the American people.

 

American Heart Association volunteers and staff, along with our public health partners, have been working for over a decade to see this legislation become law.  We are extremely proud to have played a major role in moving this legislation through Congress and to have had the opportunity to join our Congressional champions today in witnessing the bill signing.

This measure, along with many other policy initiatives the association supports on the local, state and national level, directly impacts our mission to build healthier lives free of cardiovascular disease and stroke.  This historic public health victory would not have been possible without the tenacious efforts and unwavering support of our You’re the Cure advocates — the volunteers and staff who worked to generate Congressional and public support for the measure.

If you are not already involved, you too can play a vital role in American Heart Association legislative advocacy efforts. Start today by thanking Members of Congress and the President for making this legislation a reality. Visit heartprescription.org to send your email.

I would also like to extend a personal and very special thank you to former CEOs Cass Wheeler and Dudley Hafner, who devoted much of their AHA careers to advancing this issue by meeting with members of Congress and speaking out loudly about the deadly effects of tobacco on our nation’s youth.

 

And finally, while the FDA bill represents an important victory, the fight against tobacco is not over.  We must continue to push for smoke-free workplace laws, higher tobacco excise taxes and funding for comprehensive smoking prevention cessation programs to help break the cycle of addiction and create a healthier environment for our families.  We’re counting on your continued support to help us achieve these important goals.

Sincerely,

Nancy Brown
Chief Executive Officer

P.S. You can learn more about this bill and our other legislative issues and share your comments on our You’re the Cure blog.  You may also want to join Cass Wheeler, our former CEO, on Twitter as he shares his thoughts on this historic win. Follow him @casswheeler