Would a pharmacy-only class of drugs hasten the switch of prescription drugs?
No. A third class of medicines would not speed switch, a fact borne out by international experience. Regulatory officials in countries with a pharmacy-only category are neither more nor less likely to switch products from prescription status.The important aspect for American consumers of switching prescription medicines to nonprescription status, known as Rx-to-OTC switch, is that the U.S. system is a scientifically rigorous process based on data. In the United States, switch comes about when a company submits an application to FDA, supported by clinical studies, labeling studies, and, frequently, actual use studies which seek to replicate real world consumer use as closely as possible. FDA uses all the data—including the drug’s prescription use history—and closely considers the product’s safety, effectiveness, and labeling in making a scientific determination about the regulatory status of that medication. The Agency frequently convenes an outside expert advisory committee for its inp
