Roche Ignored Drug Safety Reports, EU Watchdog Says

Law360, New York (June 21, 2012, 8:22 PM EDT) -- Roche Holding AG is under investigation after failing to evaluate as many as 80,000 possible instances of adverse drug reactions, the European Medicines Agency said Thursday, cautioning that there isn't yet evidence of a public health risk.

The inquiry stems from an inspection by the U.K.'s Medicines and Healthcare Products Regulatory Agency, or MHRA, that turned up reams of reports Roche neglected to scrutinize to see if they warranted notifying European Union authorities.

Among those reports were more than 15,000 deaths and like the rest of...
To view the full article, register now.