Gottlieb Q&A: Off-Label Communications And Right-To-Try
US FDA Commissioner nominee favors making up-to-date, accurate information available to patients and providers, but will that translate to more freedom for sponsor communications?
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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.
CBER Director Peter Marks says center will mobilize necessary resources to make sure these provisions are implemented; Marks also offered comments in opposition to 'right-to-try' legislation.
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.