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Off-Label Promotion: FDA Commissioner's Concerns Stem From Ethics Of Informed Consent

 
• By Nielsen Hobbs

'My personal view is that companies controlling that information is not the ideal,' Robert Califf tells BIO. 'That doesn’t mean I’ll carry the day.'

SAN FRANCISCO – FDA Commissioner Robert Califf offered some discouraging words about more permissive regulations for off-label promotion during a talk at the Biotechnology Innovation Organization's International Convention on June 7.

Citing the ethical obligations of clinical research and his own impressions of industry behavior, Califf argued that information about medical...

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