GSK to submit comments on FDA smoking-cessation products hearing

PARSIPPANY, N.J. — The consumer products division of British drug maker GlaxoSmithKline wants its voice heard at a Food and Drug Administration hearing scheduled for next year on a section in a 2009 law to regulate tobacco products that deals with smoking-cessation products, the company said Monday.

GSK Consumer Healthcare said it would submit written comments to the FDA's public docket in January 2013 concerning its positions on Sec. 918 of the Family Smoking Prevention and Tobacco Control Act of 2009, scheduled for April 2013. The section deals with products used to treat dependence on tobacco.

The purpose of the hearing is to advance the discussion of expanding the use of smoking cessation medicines, including nicotine-replacement therapy. The drug maker said it endorsed the FDA's actions and "strongly" recommended that the agency adopt a comprehensive regulatory policy that allows smokers multiple approaches to quitting smoking, citing a study indicating that about 70% of the more than 45 million Americans who smoke want to quit.

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