The Food and Drug Administration oversees a broad range of medical and consumer products. In fact, the agency estimates that up to a quarter of all U.S. consumer spending is on FDA-regulated items. The Pew Charitable Trusts understands the tremendous impact these products have on public health. This project complements our work supporting drug safety and effective and efficient regulation of medical devices by focusing attention on over-the-counter drugs and dietary supplements, as well as fields such as regenerative medicine, in order to safeguard consumers and patients.
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When the Food and Drug Administration approves a drug or medical device, it does so for a specific, “intended” use that has been supported by rigorous testing and clinical trials. The product’s label describes the conditions it was tested to treat and the evidence supporting that use. Yet approved drugs and devices may have other benefits. Such “off-label” uses are a... Read More
The Pew Charitable Trusts sent a letter May 17 to Senators Johnny Isakson (R-GA) and Bob Casey (D-PA) thanking them for their bipartisan efforts to reform the over-the-counter (OTC) monograph system. Pew also sent a joint letter with five public health organizations supporting the language and expressing hope that it will be included in the Food and Drug Administration Reauthorization Act of 2017. Read More
Pew and the American Academy of Pediatrics Outline Principles for Over-the-Counter Drug Regulation Reform
Americans routinely turn to over-the-counter (OTC) drugs to treat a wide variety of ailments, from coughs to stomachaches. And they have a growing number of choices: The OTC market now includes more than 300,000 products, with annual sales of $32 billion. But the framework for evaluating these medications, established in 1972, has not kept pace with scientific discovery, putting consumers at risk... Read More