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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Kirsten Moore, director of The Pew Charitable Trusts’ health care products project, testified Sept. 13 before the House of Representatives Energy and Commerce Subcommittee on Health about the need to reform over-the-counter (OTC) drug regulation. Read More
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