OVER-THE-COUNTER DRUGS: FDA Orders New Labelling Standard
Vice President Al Gore will announce today a set of new FDA labeling requirements for over-the-counter medications similar to those instituted for food products in the early part of the decade. The new regulations "will require the manufacturers of some 100,000 products to follow a strict format for describing a drug's ingredients, uses, warnings and directions." In a statement yesterday, Gore said, "For parents, the elderly, and for all Americans, being able to read and understand over-the-counter drug labels is essential to their health" (Schwartz, Washington Post, 3/11). The regulations require that labels list ingredients and the symptoms they are designed to treat in the same place on every package, larger print for warnings and other important information and the "same critical information for all drugs so that consumers can compare them easily." The agency also will recommend including a phone number on drug packaging that a consumer can call with questions. For its part, the FDA will launch a public relations campaign to introduce consumers to the new labels (Davis, USA Today, 3/11). The New York Times reports that the labels will begin appearing in early 2000, with all manufacturers required to comply within two years. A White House official said, "We anticipate that this will occur very rapidly, with the backing of both the pharmacists and the manufacturers. Once this gets out into the marketplace, many of the producers will start doing this for all their products because consumers become very comfortable with it and, in some cases, will think that if it doesn't have a new label the product will be old" (Stolberg, 3/11).
Studies show that misuse of over-the-counter drugs "results in more than 170,000 hospitalizations each year, costing $750 million annually. Half could be prevented by better consumer information" (Wall Street Journal, 3/11). The FDA said the changes will cost the industry about $58 million to implement, but could save the health care system $140 million in hospitalization costs. A representative of the Nonprescription Drug Manufacturers Association said the group was "very pleased" with the changes. Sidney Wolfe, director of Public Citizen's Health Research Group, called the regulations "an important step forward, just as it has proven to be with foods" (Cimons, Los Angeles Times, 3/11). But Wolfe "said that the labels should also give users stronger warnings about potential risks that the companies may want to play down" (Washington Post, 3/11).