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:

Email Newsletters

More in News

Lack of marketing partner delays Afrezza launch

Lack of marketing partner delays Afrezza launch

Afrezza was heralded as one of the most innovative diabetes products of the last decade. So, why hasn't MannKind set a firm launch date for the product?

In sunny world of LASIK marketers, a dark underbelly

In sunny world of LASIK marketers, a dark ...

Last week, the former FDA branch chief who originally approved LASIK machines asked FDA to reconsider its denial last month of his petition to ban these devices.

BMS Q2 sales slip, Eliquis, Yervoy soar

BMS Q2 sales slip, Eliquis, Yervoy soar

The company attributed part of the Eliquis boost to the BMS-Pfizer DTC and education efforts.