Yell It From The Rooftops: Hep C Drug Safety Notice Another Example Of FDA's Limited Power Over Prescribers
After its bully pulpit, the US FDA's options to encourage physicians to follow labeling recommendations for hepatitis C drugs are limited.
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National Academies of Sciences, Engineering, and Medicine committee meeting suggest it is difficult to write condition-specific guidelines for opioid prescribing in the primary care setting.
Drug safety focused meetings would once have been almost certain to focus on mandatory risk management plans as a solution. But FDA not only didn’t propose that approach, it actively discouraged its advisors from considering it.