Simple, Relevant Information Under the action plan, health professionals will voluntarily provide prescription drug information to patients in the form of leaflets written in simple language. Useful prescription drug information must reach at least 75 percent of patients by the year 2000, in keeping with the Department of Health and Human Services goal under its Healthy People 2000 program. By 2006, the information must reach at least 95 percent of patients. If these goals aren't met, FDA may require the information by regulation. The plan was developed with the input of health professionals and consumer, government and industry representatives.
Health professionals are responsible for getting the information to patients.
FDA is available for technical assistance and will work to educate the public about the plan, according to Thomas McGinnis, a pharmacist and FDA's associate director of pharmacy affairs. FDA will survey consumers nationwide in the year 2000 and again in 2006 to determine if the goals have been met. The agency will evaluate samples of the patient labeling to make sure it provides the required information in simple language. FDA has tried before to provide prescription medicine information to consumers. A rule the agency proposed in 1979 would have required manufacturers to include leaflets known as patient package inserts, or PPIs, with 10 prescription drugs or drug classes.