Contrave TV Ad's Slimmed Down Adverse Events Draw FDA Rebuke
Executive Summary
Referencing opioids and suicidal thoughts is not sufficient, US regulators say; letter comes as Orexigen has seen an upsurge in Contrave prescriptions.
You may also be interested in...
US FDA Actions On Rx Drug Promos Covered New Territory Last Year
Office of Prescription Drug Promotion issued just six letters citing companies for improper drug promotion in 2020, including the placement of safety information in an email and making unfounded COVID-19 claims. New research projects focus on celebrity endorsements, medical conference materials.
Xtampza ER Warnings Can't Be Hidden Behind Table And Chairs, US FDA Tells Collegium
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.
Rx Promotion Citations By US FDA Plummet; UCLA Webpage Elicits Final Letter Of 2017
Last year's record low five letters came as FDA launched flurry of studies on DTC, professional ads; 'Bad Ad' complaints totaled more than 100.