• Most Popular
  • Most Shared

US FDA objects to J&J unit promo for heart drug

Wed Nov 7, 2007 4:02pm EST

Stocks

   

Regulatory News

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/

(C) Reuters 2007. All rights reserved. Republication or redistribution ofReuters content, including by caching, framing or similar means, is expresslyprohibited without the prior written consent of Reuters. Reuters and the Reuterssphere logo are registered trademarks and trademarks of the Reuters group ofcompanies around the world.nN07521656



More from Reuters

Joint Terminal Attack Controller SSgt Clinton J. Herbison, a U.S. Airman from the 817 Expeditionary Air Support Operations Squadron (EASOS) takes a break during a night mission near Honaker Miracle camp at the Pesh valley of Kunar Province August 12, 2009. Credit: REUTERS/Carlos Barria

Pictures of the Year

A look at the best photos of 2009.  Slideshow 

    The Dalai Lama jokes with a nasal spray after being asked his opinion on the swine flu during a press conference after his first lecture in Lausanne, Switzerland, August 4, 2009. REUTERS/ Valentin Flauraud

    What a wacky year it's been...

    Um, what's up the Dalai Lama's nose? "Oddly Enough" editor Bob Basler rounds up the goofiest photos of the year.  Full Article 

    A caution sign is seen next to a stock board at the Australian Securities Exchange (ASX) in Sydney September 5, 2008. REUTERS/Daniel Munoz
    Political Risk in 2010:

    Don't say we didn't warn you

    With the financial crisis (mostly) in the past, U.S. investors are eying a fresh start to the coming year. Here's a look at what speedbumps lie ahead.  Full Article