DDMAC to Scios: halt Natrecor promo

Share this article:
The 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.”

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Features

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete September 2014 Digital Edition

Read the complete September 2014 Digital Edition

Click the above link to access the complete Digital Edition of the August 2014 issue of MM&M, with all text, charts and pictures.

Medical marketing needs mainstream Mad Men

Medical marketing needs mainstream Mad Men

Agencies must generate emotional resonance with the target audience, not unlike Apple, Pepsi or Nike

Are discounts cutting out co-pays?

GSK's decision to cut Advair's price spurred some PBMs to put it back on formulary. Will drugmaker discounts diminish the need for loyalty programs? How can these programs stay relevant beyond giving co-pay assistance?