U.S. House of Representatives
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چکیده
The American Medical Association (AMA) appreciates the U.S. House of Representatives Committee on Energy and Commerce Subcommittee on Health’s (Subcommittee) efforts to build on and accelerate wide-spread clinical applications of innovative tests. We welcome the opportunity to respond to the questions posed by the Subcommittee. Our responses are below along with examples that demonstrate the differences between medical testing services offered by physicians in a single laboratory to address a specific patient medical need versus the packaged commercial products that are shipped by manufacturers to laboratories across the country. The AMA strongly supports both legislative reform of (1) the current oversight of laboratories where testing services are offered by physicians; and (2) the Food and Drug Administration’s (FDA or Agency) regulation of mass-produced commercial test kits. Congressional action is needed in order to sustain and encourage widespread access to well-established tests while removing burdensome regulatory barriers to rapid adoption of innovative tests that are clinically indicated.
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تاریخ انتشار 2015