Before the FDA considers a prescription drug product for reclassification to OTC status, the drug must meet certain criteria. First, the indication or indications for which the product is to be used on an OTC basis should be similar to its prescription indication or indications and must permit easy diagnosis and monitoring by the patient. This information is derived from clinical trial results and postmarketing safety surveillance data, and it is submitted to the FDA by the manufacturer of the product. Finally, the drug should not have properties that make it impractical for OTC use, such as special monitoring requirements or a narrow therapeutic index. 6 Impact of Reclassified Products Changing drugs from prescription to OTC status permits patients to conveniently and effectively self-treat a number of minor ailments.
Consumers view reclassified products as strong, economic therapies.
According to one argument, by allowing patients to self-treat minor illnesses, physicians are allowed more time to care for patients with more serious health problems. However, only 40 percent of physicians responding to a 1995 survey approved of reclassification of products from prescription to OTC status. Changing a product's status from prescription to OTC often allows the manufacturer to market the product for several more years without generic competition. 9 Sales volume also increases when a product is reclassified to OTC status. 7 Increased sales volume allows the manufacturer to decrease the retail cost of the product while maintaining profitability.