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Off-label prescribing might get boost from FDA: new draft guidance would allow drug companies to put off-label information in the hands of physicians.(PHARMACY BEST PRACTICES)

Publication: Managed Healthcare Executive
Publication Date: 01-APR-08
Format: Online
Delivery: Immediate Online Access

Article Excerpt
[ILLUSTRATION OMITTED]

USING DRUGS FOR CONDITIONS other than what's on the label is not new, but it may receive more encouragement if draft guidance from the Food & Drug Administration (FDA) is approved. Allowing more off-label use might also increase payers' pharmacy costs.

The FDA...

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...is leaning toward allowing drug companies to give physicians journal articles that discuss product uses not yet approved by the FDA. The rules also state that drug companies do not need to promise to adequately test the unapproved use of the particular drug. The draft guidance would...

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