Unapproved Uses Bill May Eventually Pass, But Would Likely Need Additional Safeguards
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.
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At hearing, House Energy & Commerce Committee leadership supports legislation to provide clarity and more latitude in off-label communications at hearing but Democrats oppose broad change.
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.
Report sponsored by Association for Accessible Medicines in US says drugs with restricted distribution programs had total sales of $22.7bn in 2016; seven drugs had sales topping $1bn.