October 23, 2012
Europe's drug and pharmaceutical regulator, the European Medicines Agency (EMA), announced today that it has launched an investigation into Swiss pharmaceutical company Roche (NASDAQOTH: RHHBY ) over allegations that the company failed to report side effects of its products.
The agency will look at whether the company upheld legal responsibilities to ensure its 19 products are safe for European markets, according to an EMA press release.
The investigation comes after a similar action by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), which first pointed out potential flaws in Roche's actions.
The EMA will pass on any findings to the European Commission, which could levy fines of up to 5% of all Roche's European Union sales.
Investigators from the MHRA identified up to 80,000 possible reports of side effects that the company hadn't handled properly. The claims include some of the company's biggest sellers, such as the influenza drug Tamiflu and cancer drug Avastin.
Roche said it was cooperating with authorities, and the EMA said that all the company's drugs remained authorized for sale and use.