J&J Division Receives DDMAC Letter

November 14, 2007

Scios, a subsidiary of Johnson & Johnson (J&J), was cited by the FDA’s Division of Drug Marketing, Advertising and Communication (DDMAC) for disseminating promotional materials for its congestive heart failure treatment Natrecor without including the required indication and safety information.

The materials in question, which were the subject of a Nov. 6 untitled letter from the agency, were intended for use as reminder labeling, which is exempt from the requirements under the Federal Food, Drug and Cosmetic Act that promotional pieces include such information.

Because of the pictographic nature of the materials distributed, the FDA said they are not appropriate as reminder labeling.

The items cited, a mouse pad and pen, feature a patient in a hospital bed, hooked up to a heart monitor. The room is almost full of water, and only the patient’s head and shoulders are above the water line. 

“The image evokes the concept of a sedentary hospital patient drowning,” the FDA told Scios in the letter. “The combination of this image with the Natrecor [nesiritide] logo that is imprinted on the promotional materials suggests that Natrecor is indicated for seriously ill patients who have difficulty breathing while at rest because of fluid accumulation within the lungs, a suggestion that is [in part] consistent with Natrecor’s indication.”

The agency told Scios to stop distributing the materials and respond in writing by Nov. 21 stating whether it plans to comply. In addition, the FDA is requesting a list of all violative materials for Natrecor and an explanation of the plan for discontinuing their use.

Scios did not respond to a request for comment by press time. The warning letter can be accessed at www.fda.gov/cder/warn/2007/Natrecor_Letter.pdf, and copies of the marketing materials can be viewed at www.fda.gov/cder/warn/2007/Natrecor_Promo.pdf.