Off-Label Discussion, But No Additions, For House User Fee Bill
Several Republicans remain interested in expanding off-label communications, suggesting the issue could come up outside the user fee context, potentially as part of future drug pricing discussions.
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User fee legislation headed for a US House vote this week would require pediatric studies of certain molecularly targeted cancer drugs; the requirement, which could apply to some orphan drugs, would not take effect for three years.
It’s not realistic to expect sudden changes in US agency’s regulation of medical product communications to healthcare providers and payers given the other pressing issues facing new Commissioner Scott Gottlieb, Medical Information Working Group’s Klasmeier says.
House Energy and Commerce Committee refines FDA Reauthorization Act and adopts a ‘sense of Congress’ resolution on drug pricing, but largely steers clear of other potentially controversial add-ons that could bog down the measure.