FDA Hearing To Explore New OTC Drug Classification

The U.S. Food and Drug Administration (FDA or the Agency) is announcing a public hearing on March 22-23, 2012 to obtain input on a new paradigm the Agency is considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use. These conditions of safe use would be specific to the drug product and might require sale in certain pre-defined healthcare settings, such as a pharmacy. This public hearing is being held to obtain information and comments from the public on the feasibility of this paradigm and its potential benefits and costs.