Amgen is the subject of the FDA’s latest untitled letters. The regulator’s Office of Prescription Drug Promotion (OPDP) knocked the company for a mailer promoting it its chronic kidney disease anemia drug Aranesp.
The marketing watchdog’s roster of marketing missteps include what it says is a failure to disclose “material facts from the warnings and precautions section” of the PI. The regulator noted that the drugmaker did include hints like “Visit Aranesp.com for more information,” and “Please see accompanying Aranesp full prescribing information,” in the mailer, but writes that these directions do not make up for this same information not appearing in the mailer itself.
OPDP objections also include a glossing over of patient-dependent dosing, even though the PI includes “extensive instructions that are material for dosing Aranesp, including the starting dose, several different dosing schedules, monitoring requirements, and instructions for subsequent dose adjustments.”