While the U.S. Food and Drug Administration (FDA) is a world leader in its vigorous approval process for prescription medications, the FDA has granted approval for only 17 brands that sought a change from prescription-only (Rx) to over-the-counter (OTC) status during the past decade. Most of those occurred in categories where other drugs had already switched and were simply new brands or active ingredients entering the existing OTC category.
Regulatory agencies outside the U.S. have been much more aggressive in approving medication switches for conditions. One of the main reasons for this disparity is that the U.S. has just two classes of medications (Rx and OTC) versus many other countries’ third class of drugs, known as behind-the-counter (BTC). The additional category enables pharmacists to function as an informed intermediary to assist consumers with selecting and safely using nonprescription medications.
The Kline/IRI report, “Flipping the Switch: Disparity between the United States and Rest of World,” outlines the current switch environment in the U.S. and around the world, as well as Rx products likely to switch in the future in the U.S.
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