GlaxoSmithKline Consumer Healthcare Recommends Maintaining FDA'S Current Two-Class D...( Consumers Benefit from Conveni...)

Consumers Benefit from Convenient and Cost-effective Access to

Over-the-Counter Self-Treatment Options

PITTSBURGH, Nov. 14 /PRNewswire/ -- American consumers are well-served by the Food and Drug Administration's current two-class system of prescription (Rx) and over-the-counter (OTC) medications, George Quesnelle, president of GlaxoSmithKline Consumer Healthcare, told an FDA public meeting today in Washington, DC. The Agency is studying the possibility of a third class of drugs, called Behind-the-Counter, which would be available without a prescription but would require a pharmacist consultation prior to purchase.

Citing a number of well-known and trusted OTC products consumers rely on daily, Quesnelle highlighted how the current two-class system has yielded increased access to life-enhancing and, in some cases, life-saving medications for consumers.

Wide Access To OTC Medicines Provides Public Health Benefits

An estimated 7.6 million adults have successfully quit smoking since cessation products like NicoDerm(R)CQ and Nicorette(R) achieved OTC status and wider availability in 1996. When orlistat weight loss medication was available only by prescription, 96,000 people tried the product during a four month period June through September, 2006. Since the medicine was made widely available as alli, the OTC product, more than 2 million starter kits were sold during a similar four month timeframe, June through September, 2007, indicating significant interest among consumers in managing their weight. Other well-known brands are so widely used today that many consumers may not even recall that they, too, were once available by prescription only: low-dose (cardiac) aspirin, various brands of pain relievers such as Motrin(R), Aleve(R), and Tylenol(R), and specialty treatments such as Claritin(R), Prilosec(R) and Monistat(R).

"OTC medicines play a vital role in America's healthcare system. Broad OTC access leads to i
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