EHS
EHS

STAT Plus: FDA scolds Eisai after a rep makes off-label statements to doctors

In an unexpected move, the Food and Drug Administration has scolded a drug maker because one of its sales reps discussed unapproved uses of a medicine at a luncheon meeting for physicians.

The episode involved an Eisai sales rep, who made the remarks about the Fycompa epilepsy drug, according to a letter the agency sent the drug maker last week and posted on its website on Wednesday. It is not clear what unapproved use the rep was discussing or the details of the event, however, because portions of the letter were redacted.

Continue to STAT Plus to read the full story…

Source link

EHS
Back to top button