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Unapproved Uses Bill May Eventually Pass, But Would Likely Need Additional Safeguards

 
• By Michael Cipriano

Off-label communication amendments tabled at House markup of user fee legislation after Democrats object; the two sides agreed to discuss the issue further down the road.

Render illustration of computer keyboard; with the print OFF-LABEL on a red button; and a small bottle of pillls.

Congress may eventually pass clear rules of the road regarding pre-approval and off-label communications for drugmakers, but current Republican proposals would likely need to include a series of extra safeguards, as well as more specificity with regard to the information sponsors can share to gain bipartisan support.

The subject was debated at a June 7 House Energy and Commerce Committee markup of the user fee reauthorization, which...

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