US FDA objects to J&J unit promo for heart drug
WASHINGTON, Nov 7 (Reuters) - U.S. regulators have told a Johnson & Johnson (JNJ.N) unit to stop distributing a computer mouse pad and pen promoting heart failure drug Natrecor, in a letter released on Wednesday.
The mouse pad and pen by Johnson & Johnson's Scios Inc unit listed the drug name and depicted a man sitting in a hospital bed with water up to his shoulders.
"Simply put, the image evokes the concept of a sedentary hospital patient drowning," the Food and Drug Administration said in a letter to Scios.
Combining the image with the Natrecor logo "suggests that Natrecor treatment would be appropriate for this patient and others like him" who have trouble breathing because of fluid build-up in the lungs, the FDA said.
The agency said the materials went beyond "reminder" promotions, which do not have to include risk information as long as they simply mention a drug's name and make no suggestions about effectiveness or appropriate patient populations.
"We have determined that your promotional materials are not appropriate reminder labeling," said the letter, which was posted on the FDA Web site here .
The agency asked Scios to immediately stop distributing the materials or similar promotions.
Scios spokesman Chris Ernst said the company had received the letter "and will be cooperating with the agency accordingly."
(Reporting by Lisa Richwine; Editing by Tim Dobbyn)
((lisa.richwine@reuters.com; +1 202 310-5691; Reuters Messaging: lisa.richwine.reuters.com@reuters.net)) Keywords: JNJ NATRECOR/
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