THE WHITE HOUSE

Office of the Vice President

"With this new regulation I am unveiling today,we will ensure that the labels on medicine we buy over the counter are no longer written in language that is over our heads. Starting here and now, when children wake up sick in the middle of the night, parents won't have to read a dictionary to read the directions. And people won't need a magnifying glass to find out what's in their medicine."

--Vice President Gore

     VICE PRESIDENT GORE UNVEILS NEW SAFETY LABELING REQUIREMENTS 
                  FOR OVER-THE-COUNTER MEDICATIONS
                           March 11, 1999

Today, Vice President Gore is announcing that the Clinton Administration is unveiling a landmark FDA regulation that requires over-the-counter drug products to use a new label with larger print and clearer language, making it easier for consumers to understand product warnings and comply with dosage guidance. The Vice President also announced that FDA will launch a new national public information campaign to help consumers learn more about over-the counter-drugs and the information provided by the new labels. The new regulation and campaign, that builds on the President's record of improving consumer protections and health will provide Americans with important information about their medications in a user friendly way and takes a critical step towards preventing the tens of thousands of unnecessary hospitalizations caused by misuse of over-the-counter medications each year.

          MISUSE OF OVER-THE-COUNTER MEDICATIONS IS COMMON 
                    AND POTENTIALLY DANGEROUS

More and more Americans use over-the-counter medications to treat routine illnesses. Each year, Americans purchase five billion over-the-counter drug products for a wide variety of ailments, ranging from headaches to arthritis to sore throats. Approximately 100,000 over-the-counter drugs can be used to treat routine illnesses without a prescription, requiring consumers to make their own judgement about what drug to take, how to take it, and whether or not to give it to their children.

Misusing over-the-counter drugs can be dangerous. Although over-the-counter drugs are generally very safe, their misuse causes over 170,000 hospitalizations each year at an annual cost of $750 million. Studies estimate that half of these hospitalizations could be prevented by better consumer education and information. These unacceptably high hospitalization rates underscore how important it is that consumers understand the information provided by drug product labeling.

Children and the elderly are at particular risk of accidentally misusing an over-the-counter drug. The current required labeling information varies considerably among over the counter drug products. As a result, consumers often have difficulty finding, reading, and understanding critical information about these products. One study reported that 70 percent of caregivers were unable to measure the correct dose of medication for their child, indicating that many children may be at risk of being over or under medicated. In addition, studies have shown that a significant number of older Americans, who take more over-the-counter medications than the rest of the population, cannot read the small compressed type on many product labels. Because of this, they are at increased risk of taking the wrong dose of a medication or of taking an over-the-counter medication that adversely interacts with a prescription medication they are taking.

            PROVIDING CONSUMERS WITH CRITICAL INFORMATION 
                ABOUT OVER-THE-COUNTER DRUG PRODUCTS.

Today, the Vice President announced:

      New regulations providing easy to understand labeling for
     over-the-counter drugs.  The new FDA regulation provides consumers
     with the essential information necessary to make informed decisions
     about their family's health care. The new labels:

     --   Require a standardized, easy-to-follow format. The regulation
          requires labels to list ingredients in the same place on every
          product and explain which ingredients are used to treat 
          specific symptoms;

     --   Include critical information about the drug product. The
          regulation clearly presents a drug's ingredients, dose, and
          warnings, making it easier for consumers to understand 
          essential information about the medication's expected 
          effectiveness and associated risks, determine appropriate 
          dosage for children and adults, and compare the content of 
          different products;

     --   Increase the size of the label type so it can be easily read.
          The regulation specifies the minimum type size for labels in
          order to make them easier to read, based on studies that 
          included older people and demonstrated how important type 
          size is to reader comprehension; and

     --   Allow for a modified format for small packages. The 
          regulation allows packages that are too small to use the 
          standardized label to use a modified version that includes 
          the most essential information on the new label.

     This new label, which applies to all 100,000 over-the-counter drugs
     and drug cosmetics, will begin to appear on some of these products
     this spring and will be on the majority of products within two 
     years. All over-the-counter drugs will be required to adopt the 
     new labeling within the next six years. FDA is also recommending 
     that drug manufacturers include a phone number for consumers to 
     call if they have questions about the product.

      A new public information campaign to teach consumers how to use 
     the new labels. The Vice President announced that the FDA will 
     soon launch a new public education campaign to help consumers use 
     the new labels to learn more about over-the-counter medications 
     and to encourage them to ask to their health care providers 
     questions about their medications. This campaign, which targets 
     the elderly, child care providers, and health professionals, will 
     include the placement of public service announcements in 
     newspapers and magazines, radio PSAs, and the distribution of 
     brochures and posters on the new labels through professional 
     organizations, such as the National Association of Chain Drug 
     Stores and the Nonprescription Drug Manufacturers Association.

      Awarded FDA with a "plain language" award for these new 
     improvements.  As part of his reinventing government initiative, 
     the Vice President also gave the FDA a plain language award for 
     developing a clear new format to help consumers improve their 
     health.