The European Medicines Agency, similar to the FDA in the States, is launching infringement proceedings against drug giant Roche. It is alleged that Roche failed to investigate over 80,000 reports from consumers of adverse effects of drugs sold in the United States.
The problem came to the attention of the EMA when a routine inspection revealed these 80,000 reports untouched in Roche’s computer system. The 80,000 reports included over 15,000 deaths, but in spite of the severity, no evaluation of the cases had been done. Instead, the 19 drugs that are in question remain on the market without any investigation into their safety.
The drugs include a flu vaccine and several cancer drugs.
The investigation will last for 18 months, and if Roche is found to be in violation, it could be fined up to 5% of its sales revenue.
For its part, Roche states that patient safety is of “paramount importance.” This is the standard response of any pharmaceutical company that wants to portray a compassionate corporate image to hide its profit-obsessed reality. Will another slap on the wrist do anything to change this backward culture? From past experience, we don’t believe so. What do you think? Should the FDA and the EMA go farther in their discipline of Roche?