A Statement from GlaxoSmithKline Consumer Healthcare on FDA Public Hearing
Regarding Expanded Use of Smoking Cessation Products
PARSIPPANY, N.J., Dec. 17, 2012
PARSIPPANY, N.J., Dec. 17, 2012 /PRNewswire/ -- GlaxoSmithKline (GSK) Consumer
Healthcare looks to the U.S. Food and Drug Administration (FDA) to advance the
discussion of expanded uses of smoking cessation medicines, including nicotine
replacement therapy (NRT), by holding a hearing related to Sec. 918 of the
2009 Family Smoking Prevention and Tobacco Control Act.
GSK endorses FDA's actions and any action designed to help more smokers stop
their dependence on tobacco, and strongly recommends the FDA adopt a
comprehensive regulatory policy that allows smokers options of flexible and
novel approaches for quitting.
Currently, more than 45 million Americans continue to smoke, and research
indicates approximately 70 percent of them want to quit. However, success
rates remain sub-optimal. Tobacco use causes over 400,000 deaths in the United
States each year and approximately 8.6 million Americans have chronic
illnesses related to smoking.
Opening the discussion around Sec. 918 represents a tremendous opportunity to
maximize the public health impact and lead to an increased interest and
ability to quit. Numerous clinical studies and the current U.S. Public Health
Service (PHS) Guideline on Treating Tobacco Use and Dependence already support
the use of extended indications for NRT. In fact, these guidelines support the
use of NRT products longer than directed for a subset of smokers for whom
flexible use of NRT products is needed to help them quit smoking.
There is anabundance of evidence that NRT products have safely and
effectively helped millions of people around the world quit smoking, and as a
result, have significantly reduced their exposure to the risks of cancer and
other smoking-related diseases. Several other countries already encourage the
use of NRT products for longer durations and with more flexible indications.
Comments gathered at the FDA hearing will be compiled in a report to Congress
recommending how to best regulate, promote and encourage innovative cessation
treatments. GSK is committed to continuing to work with medical and clinical
experts and the FDA to ensure smokers have the best possible chance to quit
smoking. GSK will submit written comments into the FDA public docket on its
position regarding Sec. 918 in Jan., 2013.
About GlaxoSmithKline Consumer Healthcare
GlaxoSmithKline Consumer Healthcare is one of the world's largest
over-the-counter consumer healthcare products companies. Its well-known brands
include Nicorette^® and NicoDerm^® CQ, the leading smoking cessation
products; alli, the only FDA-OTC weight loss aid; as well as medicine cabinet
staples, Aquafresh^®, Sensodyne^®, Tums^®, and Breathe Right^®, all of which
are trademarks owned by and/or licensed to GlaxoSmithKline Group of Companies.
GlaxoSmithKline – one of the world's leading research-based pharmaceutical and
healthcare companies – is committed to improving the quality of human life by
enabling people to do more, feel better and live longer. For company
information visit: http://www.gsk.com.
GSK Consumer Healthcare Deborah Bolding
email@example.com (973) 889-2344
GolinHarris Catherine Bocke (312) 729-4483
SOURCE GlaxoSmithKline Consumer Healthcare
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