DDMAC to Scios: halt Natrecor promoThe FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) has told Johnson & Johnson's Scios unit to stop distributing promotional computer mousepads and pens to physicians for its heart failure drug Natrecor.
In a letter sent to Scios, the FDA said the mousepads and pens list the prescription drug's name and depict a man sitting in a hospital bed with water up to his shoulders.
DDMAC said the promotional materials go beyond being “reminder” ads, which do not have to include risk information as long as they simply state the drug's name without making suggestions about effectiveness or appropriate patient populations.
“Simply put, the image evokes the concept of a sedentary hospital patient drowning,” said DDMAC's regulatory review officer Lisa Hubbard in the letter.
The combination of the image with the Natrecor logo suggests that “Natrecor is indicated for seriously ill patients who have difficulty breathing while at rest because of fluid accumulation within the lungs,” Hubbard wrote. “Reminder pieces may not include, among other things, representations or suggestions concerning effectiveness or patient population. Because this image makes these implications, the pieces cited above are not considered reminder labeling and appropriate indication and risk information need to be included. However, these pieces fail to include this information.”
DDMAC said it has determined the pieces “misbrand” Natrecor.
DDMAC requested that Scios stop distributing the promotional materials and urged the drugmaker to respond to the agency in writing by Nov. 21.
Scios spokesperson Chris Ernst said in a published report the company will contact the FDA about the best way to resolve the complaints.
“We will be cooperating with the agency,” Ernst said, adding that “it was a pretty small quantity” of pens and pads that were given to doctors over “just a few months.”