US FDA Calls Foul On CSL Behring Hemophilia Drug Promo
Idelvion promotional materials misleadingly imply that patients can engage in high-risk activity without consequences; first letter from US biologics promo branch in three years.
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With only seven letters last year, Office of Prescription Drug Promotion appears to be continuing its enforcement retrenchment as agency reconsiders its approach to Rx communications.
Agency objects to video interview in which Pfizer spokespeople fail to mention risks of estradiol vaginal ring, in OPDP's second enforcement letter of the year.
OPDP's first enforcement letter of 2018 is notable because it comes much earlier than 2017's first, cites an opioid, and signals that the US FDA is monitoring medical meetings.