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.