This regulatory system serves to promote public trust in the quality, effectiveness, and truthful labeling of medicinal products and also makes the pharmaceutical and biotechnology industries among the most heavily regulated businesses in our society.

Essentially all new drugs are first approved as prescription drugs. In time, however, some may be switched to over-the-counter status and be sold directly to consumers. OTC drugs are subject to the same regulatory requirements as prescription drugs except that the regulation of their advertising is under the authority of the FTC rather than the FDA. The tests for determining whether a drug can be sold OTC are (1) whether it can be labeled for use by the consumer without the need for a physician and (2) whether it is safe and effective for OTC use. The FDA has historically limited the use of OTC products to symptomatic conditions such as colds, heartburn, and headaches that can be diagnosed without the need for a physician. Furthermore, to promote safe use, the FDA has typically approved for OTC use only drugs of low inherent risk such as antacids and sunscreens or, in the case of drugs that are potentially toxic such as nonsteroidal anti-inflammatory agents and antihistaminics, lower doses than are available by prescription. Drugs with sufficient abuse potential to be scheduled under the Controlled Substances Act cannot be offered OTC.

The only nicotine-containing products currently approved by the FDA for OTC use are Nicorette gum, Nicoderm CQ patch, and Nicotrol patch. The FDA decision to permit these products to switch from prescription to OTC status required discussion at two meetings of the Non-Prescription Drug Advisory Committee before action was taken. A later decision to permit mint-flavored Nicorette gum also required considerable time and discussion. The concerns raised in these discussions were whether these products would actually be effective in an OTC setting without accompanying professional intervention and whether increased abuse and/or cardiovascular risk might develop. Subsequent experience has been reassuring on all counts (Hughes et al., 1999a).

Nicotine-containing drugs are currently approved by the FDA only to reduce withdrawal symptoms as an aid in smoking cessation. Their labeling clearly states that the goal of treatment is cessation of smoking and subsequent withdrawal from the nicotine-containing tobacco product. The labeling of the prescription products advises against chronic use beyond six months and over-the-counter labeling advises against long-term use while continuing to smoke or use other nicotine-containing products. Although use as part of a comprehensive behavioral smoking cessation program is encouraged, there is no information in the labeling of nicotine-containing products about their effectiveness in combination with other programs or Zyban (bupropion SR). In contrast, the labeling for Zyban



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