US FDA Targets Consumers For Medication Guide Plan

The US Food and Drug Administration is conduct a survey of consumers to discover the quantity and quality of information which they receive about prescribed medications. To this end, the agency has contracted with the Market Facts company to discover how much and what kind of information, both written and oral, that consumers receive.

The survey is being conducted as part of the FDA's medication guide proposal. It will evaluate whether the requirements of the Omnibus Budget Reconciliation Act of 1990, which says consumers covered by Medicaid should receive counseling from their pharmacists, have improved standards of information. Similar surveys were conducted in 1982, 1984 and 1992, says the Pink Sheet, noting that the 1992 study is now being prepared for publication as a peer-reviewed journal article.

The proposed rule would require prescription drug producers and/or distributors to prepare patient labeling and dispensers to provide labeling "to each patient or agent of the patient receiving a newly-prescribed, covered product, and to any patient or agent who requests patient labeling when receiving a refill." The agency has been dissuaded from requiring automatic provision of patent labeling with refills because this would place "a relatively large economic burden" on pharmacists, and has estimated that the patient labeling requirement would mean associated costs close to the $100 million threshold that defines a significant regulatory action.