Healthy Skepticism Library item: 7298

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

BioMarin takes down drug web site after FDA letter
Yahoo Finance 2006 Oct 12
http://biz.yahoo.com/bizj/061012/1360418.html?.v=1

Abstract:

The U.S. Food and Drug Administration warned BioMarin Pharmaceutical Inc. that the web site for its pediatric asthma drug Orapred was “misleading” for suggesting the drug was safer and more effective than has been shown.
The web site “minimizes and fails to communicate risk associated with the use of Orapred, broadens the indication for Orapred, and makes unsubstantiated claims,” said a letter faxed to BioMarin (NASDAQ: BMRN – News) CEO Jean-Jacques Bienaime.

The letter to the Novato-based company continued to say that the web site raises “significant public health and safety concerns because it suggests that Orapred is safer and more effective than has been demonstrated.”

Orapred is an oral liquid version of the drug prednisone that is flavored to make children like it better.

A spokeswoman for BioMarin said the company was surprised by the letter because it had submitted the content of the web site to the FDA in 2005 and had not heard any concern until the letter arrived. Nevertheless, she said the company immediately struck the site in response to the FDA’s concerns.