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GlaxoSmithKline Consumer Healthcare Recommends Maintaining FDA'S Current Two-Class Drug System

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 increased use by consumers. The availability of effective self treatment options translates into improved individual health, public health and, importantly, American lives saved. This is arguably the best global example of a system that provides consumers with safe, effective and affordable OTC medicines," said Quesnelle.

"Legislation to create a third class of drugs would unnecessarily limit consumer access to safe, affordable and effective OTC medicines without any demonstrated benefit," said Quesnelle.

Responsible Companies Work With FDA

On Conditions for Approval

The FDA has explored the idea of a third class of drugs four times over the past 25 years but found no benefit to the consumer in making a change. The current two-class system has been employed by the FDA for more than 30 years and has resulted in the approval of more than 80 ingredients for over-the- counter use that were previously available only by prescription. The approval process includes several-year reviews by the FDA to demonstrate the safety of drugs for OTC availability without the intervention of a medical professional.

As new OTC drugs are presented for FDA approval, the agency already has the ability to develop agreements on a case-by-case basis for special conditions of sale or manufacturer obligations that can help address specific product concerns. Responsible companies work with the FDA to educate, guide and support consumers in safely and effectively using their products. Labeling and consumer information materials have been a key factor in the safe and appropriate use of OTC medicines in the United States.

This can continue to be accomplished without new legislation for a new class of drugs or depriving consumers of the convenient health benefits of broad OTC access and availability.

"The mission of GlaxoSmithKline is to improve the quality of life by enabling people to do more, feel better, live longer. We strive to do that by providing prescription medications as well as widely available OTC medicines that enable people to adopt healthier lifestyles," said Quesnelle.

About GlaxoSmithKline Consumer Healthcare

GlaxoSmithKline Consumer Healthcare is one of the world's largest over-the-counter consumer healthcare products companies. Its more than 30 well-known brands include the products alli(R), Nicorette(R), NicoDerm(R) CQ, Aquafresh(R), Sensodyne(R), Tums(R) and Breathe Right(R), trademarks owned by and/or licensed to GlaxoSmithKline Group of Companies.

About GlaxoSmithKline

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and consumer healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

SOURCE GlaxoSmithKline
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