U.S. Congress scrutinizes over-the-counter drugs

Abstract

Nearly everyone agrees that the U.S. Food & Drug Administration’s system for regulating over-the-counter (OTC) drugs is outdated and broken. Now, some members of Congress want to fix it. The current system, created 45 years ago, prevents innovative products from entering the market rapidly and hampers FDA from addressing safety issues, said witnesses at a Sept. 13 hearing in the U.S. House of Representatives. OTC products include most medicines, from pain relievers to cough syrup, found on drug store shelves that consumers can buy without a doctor’s prescription. More than 300,000 OTC products are on the U.S. market, with annual sales of $32 billion, according to FDA. Most OTC products enter the market without FDA reviewing them for safety or efficacy. If a product conforms to a set of government specifications in a document called an OTC monograph, FDA considers it to be generally recognized as safe and effective, and