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Archive for November 12th, 2008

The Debate About Off-Label Prescriptions

So-called off-label uses of prescription drugs is an enduring controversy – probably because it involves a trade-off of competing value judgments.The FDA is considering loosening its monitoring of off-label prescriptions, but critics are charging that, if anything, regulations should be tightened. Many issues of science-based medicine are at the core of this controversy.

In the US the FDA (Food and Drug Administration) regulates the sale of drugs. In order for a pharmaceutical company to get a drug on the market they must complete FDA monitored clinical trials and demonstrate adequate safety and effectiveness for a specific indication. The specific indication for which a drug is approved is the on-label indication, and all other uses are off-label.

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Posted in: Pharmaceuticals

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