On September 24-25, the U.S. Food and Drug Administration (FDA) will hold a public workshop in Gaithersburg, Maryland, entitled "Providing Effective Information to Consumers About Prescription Drug Risks and Benefits," with the goal of exploring approaches to consumer-directed information that is consumer-friendly as well as accurate. FDA regulations require that patient package inserts (PPIs) be distributed to patients when certain drugs or classes of drugs are dispensed; however, this is not required for all drugs and, accordingly, not all sponsors develop PPIs. Also, where not required (but voluntarily developed by sponsors), PPIs may not contain FDA-reviewed or approved content. Under the Food and Drug Administration Amendments Act (FDAAA) of 2007, FDA can require a PPI in conjunction with a risk evaluation and mitigation strategy (REMS). Under FDA's REMS authority, the agency can require sponsors to develop or ensure that medication guides specific to their drug or class of drugs are distributed to patients by pharmacies with each prescription. Medication guides are designed for consumers and address issues specific to a drug or drug class that can help patients avoid, among other things, serious adverse reactions. FDA has independent authority to require medication guides apart from its REMS authority, and can require that they accompany drugs FDA finds to have serious risks. The agency reported in July that a 2008 evaluation of consumers revealed that the private sector has failed to meet the goals of a 1996 law that required 95 percent of people receiving new prescriptions to receive "useful" written patient information with their prescriptions by 2006. FDA is initiating this public workshop to gather stakeholders and explore new or revised approaches to the delivery of this important information to consumers, to ensure that the information is useful and is both received and understood by the average consumer. The public workshop is evidence that the agency is willing to go back to the drawing board to find an effective means of delivering accurate and consumer-friendly information about drug benefits and risks. The workshop is also likely evidence that major revisions to current agency approaches are far-off.