BIOMARIN WARNED FOR MISLEADING AND EXAGGERATED WEBSITE INFORMATION
A website for BioMarin Pharmaceutical's drug Orapred is misleading and skims over the risks associated with taking the drug, the FDA said in a warning letter.
Because of the website's content, the agency considers the drug misbranded, according to the letter, which was sent Oct. 11 and posted to the FDA's website Oct. 24. The website minimized the risks of taking Orapred, expanded the drug's indications and included unverified claims, the letter said.
BioMarin's website "raises significant public health and safety concerns because it suggests that Orapred is safer and more effective than has been demonstrated," the agency said.
The web pages promoting Orapred's efficacy lacked warnings on its risks, according to the letter. One web page had a link to the full prescribing information, including the warnings, but the FDA found this insufficient. Two other pages contained short summaries of the risk information but neglected important details, the warning letter said.
BioMarin also had a web page featuring a general discussion of asthma treatments, which implied Orapred could be used for a wider range of indications, the agency said.
The warning letter can be viewed at www.fda.gov/foi/warning_letters/g6053d.pdf (http://www.fda.gov/foi/warning_letters/g6053d.pdf).