This is an archive page. The links are no longer being updated.
Date: February 26, 1997 FOR IMMEDIATE RELEASE Contact: Food and Drug Administration --(301) 443-3285 Consumer Hotline: (800) 5324440
According to the American Pharmaceutical Association's Handbook of Nonprescription Drugs, four times as many of today's health problems are handled by consumers treating themselves with OTC drug products than by consumers seeing a physician, and 6095 percent of all illnesses are initially treated with some form of selfcare, including selfmedication with OTC drug products.
Moreover, according to this same source, although 60 percent of the medications purchased by consumers in the United States are OTC, these purchases account for less than 2 percent of the U.S. health care dollar, making it likely that, as a lowcost alternative, OTC drug use will continue to grow. This is especially true among the elderly who comprise 12 to 17 percent of the population buying OTC drugs but consume about 30 percent of all OTC medications. The elderly are projected to consume as much as 50 percent of all OTC medications by the year 2000.
The proposed rule results from several years of agency work with consumers and industry groups. Although past efforts have brought improvements in some OTC drug labeling, a lack of consistency and concerns about readability and comprehensibility of current OTC labeling convinced the agency that these proposed reforms would better ensure the goal of providing consumers with clear, consistent, reliable product information.
The public will have 120 days to comment on this proposed rule, under which OTC drug manufacturers generally would be allowed two years from the date a final rule is published to put the new label into practice. In addition, some products with lower sales that might be economically burdened by this labeling change requirement would have an extra year to comply.