FDA warns Shire on Fosrenol marketing materials

Share this article:
FDA to Shire:Halt Fosrenol materials
FDA to Shire:Halt Fosrenol materials
Shire received a warning letter from the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) asking the drugmaker to stop the distribution of specific professional marketing materials for its end stage renal disease treatment Fosrenol (lanthanum carbonate).

In the letter, DDMAC regulatory review officer Lisa Hubbard wrote that the promotional materials – a notebook and medical exam light kit – contain inappropriate reminder labeling.

“The pieces misbrand Fosrenol…as they fail to include, among other things, the drug's product indication as well as material contextual information and information addressing the risks associated with Fosrenol,” the FDA letter stated. A copy of the entire letter can be viewed by clicking here

DDMAC requested that Shire submit a written response to its warning letter by May 16.

Shire spokesman Matt Cabrey told MM&M that the drugmaker is in the process of responding to the FDA in a timely manner.

“We are committed to complying with both the letter and the spirit of the FDA regulations in the promotions of our medicines,” Cabrey said.

The Fosrenol promotional materials were initially introduced at a conference of nephrologists and were a part of Fosrenol sales reps' tool kit.

“When we received the information from the FDA, we immediately required them all to be returned to the office and they are now off the street,” Cabrey said.
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in News

Five things for Pharma Marketers to know: Friday, August 29

Five things for Pharma Marketers to know: Friday, ...

Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.