Rule on Simpler Medical Labels to Be Unveiled

The Clinton administration will announce today a new rule requiring easier-to-read labels on cough syrups, pain relievers, cold remedies and thousands of other over-the-counter medications that consumers buy every day in pharmacies and supermarkets nationwide.

The regulation is aimed at preventing an estimated 178,000 unnecessary hospitalizations every year that result from consumer confusion or failure to read carefully about the products. These hospitalizations frequently occur among the elderly, whose vision may be poor or who may be taking multiple medications that can cause adverse reactions.

The labels are expected to appear on some nonprescription drugs within weeks. They will have larger print, more white space and clearer language. Also, drug makers will be encouraged, although not required, to simplify some of the language used--substituting “lung” for “pulmonary” and “throw away” for “discard,” for example.

Americans spend between $18 billion and $20 billion on these drugs annually. In dealing with aches and pains, colds and flu, they dose themselves with over-the-counter products four times as often as they consult a physician, according to the American Pharmaceutical Assn.’s handbook of nonprescription drugs. The elderly make up 13% of the population buying over-the-counter drugs but consume about 25% of all nonprescription medications, according to the industry.

Much like the food labels that now require a detailed listing of calories, fat content and other nutritional information, the labels on about 100,000 over-the-counter drugs are expected to be very popular--one reason the regulation is being announced today by Vice President Al Gore.

“For parents, the elderly, and for all Americans, being able to read and understand over-the-counter drug labels is essential to their health,” Gore said.

Gore, who is expected to seek the Democratic presidential nomination, has in recent years served as the administration’s point man for “consumer friendly” initiatives that have a special appeal to important constituencies like parents and senior citizens; he has been the chief promoter of proposals that seek to cut bureaucratic red tape, to simplify public information to reflect “plain language” and to beef up public protections, such as in food safety.

The new over-the-counter proposals are supported by the nonprescription drug industry, which has been working with the Food and Drug Administration for several years to redesign the labels, and by numerous consumer and senior citizens’ groups.

An official of the Nonprescription Drug Manufacturers Assn., which represents the industry, described the group as “very pleased” with the outcome. And Dr. Sidney Wolfe, director of the Public Citizen’s Health Research Group, predicted that revising the label will be “an important step forward, just as it has proven to be with foods.”

The FDA has estimated the changes will cost the industry $58 million and could result in $140 million in savings if it succeeds in eliminating many unnecessary hospitalizations.

The regulation requires uniform, standard headings, subheadings and order of information.

For example, a label will first list the active ingredients and purpose of the drug and then cite its different uses.

This will be followed by specific warnings, including descriptions of when to consult a doctor before using the medication, interactions with other drugs and potential side effects.

Finally, the directions for use, including dosing, will appear boxed on the bottom of the label.

Additional information will be provided on a side panel. This will include such facts as how to store the product--at what temperature, for example--and a list of the drug’s inactive ingredients, such as colors or preservatives. The added ingredients could be especially valuable for consumers who have allergies or sensitivities to these substances.

The format itself will be streamlined, with a new bulleted, easier-to-read design, surrounded by bold lines. The text will appear in larger type.

Some smaller products will be allowed to modify certain graphic elements to accommodate the new type.

In 1990, California approved legislation asking manufacturers of over-the-counter drugs to make their labels more readable, but many groups complain that the law has no teeth because the changes are not mandatory. The new federal rule will prevail over state actions.

The new labels will begin appearing this spring on some products and will be on the majority within two years. All such drugs must adopt the new labeling within the next six years, but a White House official predicted it will not take that long.

“Our experience with the food label showed us that market forces pressured all the manufacturers to go with it almost immediately,” he said. “People saw the old labels on products and thought the product was old and wouldn’t buy it. We have no reason to believe the same pressures wouldn’t apply here.”