The U.S. Food and Drug Administration (FDA) today announced the formation of a task force to develop recommendations for enhancing the transparency of the agency’s operations and decision-making process.
To support the efforts of the task force, today the FDA issued a Federal Register notice announcing a June 24, 2009, public meeting to solicit recommendations on how the agency can make more available, useful and understandable information on its activities and decisions.
"Our administration is committed to making government open and transparent," said Health and Human Services Secretary Kathleen Sebelius. "The Transparency Task Force will give the American people a seat at the table and make the FDA more open and accountable."
"President Obama has pledged to strengthen our democracy by creating an unprecedented level of openness and public participation in government, and the FDA looks forward to participating in this process," said FDA Commissioner Margaret A. Hamburg, M.D. “I have asked the Transparency Task Force to deliver recommendations to me for ways to make more information available and foster better understanding of decision-making.”
The task force will be chaired by Principal Deputy Commissioner Joshua Sharfstein, M.D., and will include center directors, the associate commissioner for regulatory affairs, chief scientist, and the chief counsel.
"Implementation of the Transparency Task Force’s recommendations should make agency actions and decisions, and their underlying processes and bases, more transparent to the public," said Sharfstein. "I look forward to chairing this task force and reporting our findings to Commissioner Hamburg."
The Transparency Task Force will:
* Seek public input on issues related to transparency;
* Recommend ways that the agency can better explain its operations compatible with the appropriate protection of confidential information;
* Identify information the FDA should provide about specific agency operations and activities, including enforcement actions and product approvals;
* Identify problems and barriers, both internal and external, to providing useful and understandable information about FDA activities and decision-making to the public;
* Identify appropriate tools and new technologies for informing the public;
* Recommend changes to the FDA’s current operations, including internal policies and guidance, to improve the agency’s ability to provide information to the public in a timely and effective manner;
* Recommend legislative or regulatory changes, if appropriate, to improve the FDA’s ability to provide information to the public; and
* Submit a written report to the commissioner on the Transparency Task Force’s findings and recommendations.
The establishment of the task force follows President Obama’s Jan. 21, 2009 memorandum directing executive agencies to find new ways of making information available to the public rapidly and in a form that is easily accessible and user-friendly.
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Showing posts with label fda. Show all posts
Showing posts with label fda. Show all posts
Tuesday, June 2, 2009
Thursday, May 28, 2009
New Virginia Poll: 71 Percent of Voters Strongly Support FDA Regulation of Tobacco Products
/PRNewswire/ -- A new statewide poll of registered voters finds that 71 percent of voters support Congress passing a bill to give the U.S. Food and Drug Administration (FDA) the authority to regulate tobacco products. The U.S. Senate is expected to debate this issue next week, and Senators Webb and Warner will play a key role in determining whether Congress will finally pass this life-saving legislation.
"Senators Webb and Warner have a critical role to play in ensuring that strong FDA tobacco regulation is enacted into law," said Matthew L. Myers, President, Campaign for Tobacco-Free Kids. "We urge Senators Webb and Warner to vote for the bill when it's on the floor this year."
Support for FDA legislation crosses party lines, with strong majorities of Republicans (66 percent), Democrats (81 percent) and independents (71 percent) favoring FDA regulation of tobacco. In addition, support for FDA legislation is strong across virtually all demographic groups, with majorities of voters in every age bracket, education level, and income level supporting FDA regulation.
The poll shows:
-- 93 percent support restricting tobacco sales to children by requiring
ID checks for younger buyers and fining retailers who sell tobacco to
minors.
-- 79 percent support requiring tobacco companies to take measures, when
scientifically possible, to make cigarettes less harmful.
-- 86 percent support preventing tobacco companies from making claims
that some products are less harmful than others unless the FDA
determines those claims are true.
-- 87 percent support restricting tobacco marketing aimed at children
such as limiting advertising in magazines with a large percentage of
readers under age 18.
-- 73 percent support requiring the reduction or removal of harmful
ingredients, including nicotine, from tobacco products.
"There is broad, bipartisan support for FDA regulation of tobacco products," said Myers. "Virginia voters agree that it's time for Congress to address the nation's number one preventable cause of death and end the deadly status quo that allows tobacco companies to target our children and mislead the public."
In April, the U.S. House of Representatives approved legislation granting the FDA authority over tobacco products with a vote of 298-112. Similar legislation was approved 15-8 by the Senate Health, Education, Labor and Pensions Committee on May 20th and sent to the full Senate for consideration.
"There are few other issues before Congress where you will find such strong consensus across regions and across party lines. The passage of this legislation to give the FDA the authority to regulate tobacco products was long overdue. I was proud to cast my vote to address the nation's number one preventable cause of death and keep tobacco products out of the hands of our children," said Representative Gerri Connolly (D-11th).
A report by the Institute of Medicine (IOM) concluded that in order for the United States to dramatically reduce tobacco use as a significant public health problem, it is essential to provide FDA authority over tobacco products. As the IOM concluded, "The time has come for Congress to exercise its acknowledged authority to regulate the production, marketing and distribution of tobacco products."
Nationwide, tobacco use kills more than 400,000 people and costs more than $96 billion in health care bills each year. Currently, 20 percent of high school students smoke and more than 1,000 kids become new regular smokers every day. In Virginia, tobacco use kills 9,200 residents and costs the state $2.08 billion in health care bills a year, and 15.5 percent of high school students smoke.
The survey of 500 likely voters in Virginia was conducted by Global Strategy Group January 27-29, 2009 and has a margin of error of plus or minus 4.4 percentage points. Detailed poll results can be found at: www.tobaccofreekids.org.
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"Senators Webb and Warner have a critical role to play in ensuring that strong FDA tobacco regulation is enacted into law," said Matthew L. Myers, President, Campaign for Tobacco-Free Kids. "We urge Senators Webb and Warner to vote for the bill when it's on the floor this year."
Support for FDA legislation crosses party lines, with strong majorities of Republicans (66 percent), Democrats (81 percent) and independents (71 percent) favoring FDA regulation of tobacco. In addition, support for FDA legislation is strong across virtually all demographic groups, with majorities of voters in every age bracket, education level, and income level supporting FDA regulation.
The poll shows:
-- 93 percent support restricting tobacco sales to children by requiring
ID checks for younger buyers and fining retailers who sell tobacco to
minors.
-- 79 percent support requiring tobacco companies to take measures, when
scientifically possible, to make cigarettes less harmful.
-- 86 percent support preventing tobacco companies from making claims
that some products are less harmful than others unless the FDA
determines those claims are true.
-- 87 percent support restricting tobacco marketing aimed at children
such as limiting advertising in magazines with a large percentage of
readers under age 18.
-- 73 percent support requiring the reduction or removal of harmful
ingredients, including nicotine, from tobacco products.
"There is broad, bipartisan support for FDA regulation of tobacco products," said Myers. "Virginia voters agree that it's time for Congress to address the nation's number one preventable cause of death and end the deadly status quo that allows tobacco companies to target our children and mislead the public."
In April, the U.S. House of Representatives approved legislation granting the FDA authority over tobacco products with a vote of 298-112. Similar legislation was approved 15-8 by the Senate Health, Education, Labor and Pensions Committee on May 20th and sent to the full Senate for consideration.
"There are few other issues before Congress where you will find such strong consensus across regions and across party lines. The passage of this legislation to give the FDA the authority to regulate tobacco products was long overdue. I was proud to cast my vote to address the nation's number one preventable cause of death and keep tobacco products out of the hands of our children," said Representative Gerri Connolly (D-11th).
A report by the Institute of Medicine (IOM) concluded that in order for the United States to dramatically reduce tobacco use as a significant public health problem, it is essential to provide FDA authority over tobacco products. As the IOM concluded, "The time has come for Congress to exercise its acknowledged authority to regulate the production, marketing and distribution of tobacco products."
Nationwide, tobacco use kills more than 400,000 people and costs more than $96 billion in health care bills each year. Currently, 20 percent of high school students smoke and more than 1,000 kids become new regular smokers every day. In Virginia, tobacco use kills 9,200 residents and costs the state $2.08 billion in health care bills a year, and 15.5 percent of high school students smoke.
The survey of 500 likely voters in Virginia was conducted by Global Strategy Group January 27-29, 2009 and has a margin of error of plus or minus 4.4 percentage points. Detailed poll results can be found at: www.tobaccofreekids.org.
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Thursday, April 2, 2009
U.S. House Takes Giant Step Toward Historic Regulation of Tobacco Products
/PRNewswire-USNewswire/ -- The following is a statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids:
The U.S. House of Representatives today put Congress on the brink of truly historic action to reduce tobacco use -- the nation's No. 1 cause of preventable death -- by approving legislation granting the FDA authority over tobacco products. We urge the Senate to quickly pass this legislation and resist all efforts to weaken it. There are few steps Congress can take that would make a bigger difference for America's health than to pass this long-overdue legislation. It will end the special protection the tobacco industry has enjoyed for too long and protect our children and the nation's health instead.
We applaud House Energy and Commerce Committee Chairman Henry Waxman (D-CA) and Representative Todd Platts (R-PA) for their leadership in introducing this strong legislation and quickly moving it forward.
Today's 298-112 vote underscores the broad, bipartisan support for this legislation and provides strong momentum for enacting it into law this year. It has been endorsed by more than 1,000 public health, faith, medical and other organizations (see list at www.tobaccofreekids.org/reports/fda/organizations.pdf). A poll last year found that 70 percent of American voters support FDA regulation of tobacco products (see details at www.tobaccofreekids.org/fdapoll/). It has been endorsed by scientific authorities including the Institute of Medicine and the President's Cancer Panel.
Tobacco use kills more than 400,000 Americans and costs the nation $96 billion in health care bills each year. Every day, more than 1,000 children become new regular smokers. Yet tobacco products are exempt from the FDA's common-sense regulations that apply to virtually every other product we consume, from food to drugs to cosmetics. This allows tobacco companies to market their deadly and addictive products to children, deceive consumers about the harm their products cause, make changes to their products without disclosing them (such as manipulating nicotine levels in cigarettes), and resist any meaningful change to make their products less harmful.
This legislation would grant the FDA the authority and resources to effectively regulate the manufacturing, marketing and sale of tobacco products. Among other things, it would:
-- Restrict tobacco advertising and promotions, especially to children.
-- Stop illegal sales of tobacco products to children.
-- Require larger, more effective health warnings on tobacco packages and
advertising.
-- Ban misleading health claims such as "light" and "low-tar" and
strictly regulate all health claims about tobacco products to ensure
they are scientifically proven and do not discourage current tobacco
users from quitting or encourage new users to start.
-- Require tobacco companies to disclose the contents of tobacco
products, as well as changes in products and research about their
health effects.
-- Empower the FDA to require changes in tobacco products, such as the
removal or reduction of harmful ingredients or the reduction of
nicotine levels.
-- Fully fund the FDA's new tobacco-related responsibilities with a user
fee on tobacco companies so no resources are taken from the FDA's
current work.
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The U.S. House of Representatives today put Congress on the brink of truly historic action to reduce tobacco use -- the nation's No. 1 cause of preventable death -- by approving legislation granting the FDA authority over tobacco products. We urge the Senate to quickly pass this legislation and resist all efforts to weaken it. There are few steps Congress can take that would make a bigger difference for America's health than to pass this long-overdue legislation. It will end the special protection the tobacco industry has enjoyed for too long and protect our children and the nation's health instead.
We applaud House Energy and Commerce Committee Chairman Henry Waxman (D-CA) and Representative Todd Platts (R-PA) for their leadership in introducing this strong legislation and quickly moving it forward.
Today's 298-112 vote underscores the broad, bipartisan support for this legislation and provides strong momentum for enacting it into law this year. It has been endorsed by more than 1,000 public health, faith, medical and other organizations (see list at www.tobaccofreekids.org/reports/fda/organizations.pdf). A poll last year found that 70 percent of American voters support FDA regulation of tobacco products (see details at www.tobaccofreekids.org/fdapoll/). It has been endorsed by scientific authorities including the Institute of Medicine and the President's Cancer Panel.
Tobacco use kills more than 400,000 Americans and costs the nation $96 billion in health care bills each year. Every day, more than 1,000 children become new regular smokers. Yet tobacco products are exempt from the FDA's common-sense regulations that apply to virtually every other product we consume, from food to drugs to cosmetics. This allows tobacco companies to market their deadly and addictive products to children, deceive consumers about the harm their products cause, make changes to their products without disclosing them (such as manipulating nicotine levels in cigarettes), and resist any meaningful change to make their products less harmful.
This legislation would grant the FDA the authority and resources to effectively regulate the manufacturing, marketing and sale of tobacco products. Among other things, it would:
-- Restrict tobacco advertising and promotions, especially to children.
-- Stop illegal sales of tobacco products to children.
-- Require larger, more effective health warnings on tobacco packages and
advertising.
-- Ban misleading health claims such as "light" and "low-tar" and
strictly regulate all health claims about tobacco products to ensure
they are scientifically proven and do not discourage current tobacco
users from quitting or encourage new users to start.
-- Require tobacco companies to disclose the contents of tobacco
products, as well as changes in products and research about their
health effects.
-- Empower the FDA to require changes in tobacco products, such as the
removal or reduction of harmful ingredients or the reduction of
nicotine levels.
-- Fully fund the FDA's new tobacco-related responsibilities with a user
fee on tobacco companies so no resources are taken from the FDA's
current work.
-----
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