Aranesp mailer catches OPDP's attention

Share this article:
Aranesp mailer catches OPDP's attention
Aranesp mailer catches OPDP's attention

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."

Share this article:

Email Newsletters

More in News

BI rethinks hepatitis business, posts 2013 results

BI rethinks hepatitis business, posts 2013 results

Boehringer Ingelheim says it is no longer pursuing an interferon-free combination of faldaprevir and deleobuvir.

Roche wraps quarter with two fewer pipeline medications

Roche wraps quarter with two fewer pipeline medications

Roche also announced first-quarter sales shrank 1%.

2013 favored specialists, specialty Rx

2013 favored specialists, specialty Rx

The latest IMS Institute for Healthcare Informatics assessment of 2013's prescription drug use shows that 2.3% of prescriptions account for 30% of a patient's out-of-pocket prescription costs.