The Food and Drug Administration (FDA) does a good job of policing the drug companies and protecting the public health in the United States. It assures the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary supplements, and products that give off radiation. It is responsible for product approvals, over-the-counter and prescription drug labeling and drug manufacturing standards.
In Europe, however, this job is performed by the European Medicines Agency (EMA). The EMA’s responsibility spans a decentralized, European Union, spanning over a European medicines network of 40 plus national regulatory authorities. It has to be an onerous task to police over 40 national regulatory authorities. However, the EMA is not as effective as the FDA. Drug companies in that European Union commit bad acts because they know they can get away with it.
Case in point is the October 23, 2012 news that the EMA is investigating allegations that Roche failed to comply with its EMA imposed obligations to monitor the science and adverse event reporting activities to detect, assess, understand and prevent patient injuries from adverse effects of its European manufactured and distributed drugs. These allegations came from the 2012 inspection of the UK Medicines and Healthcare products Regulatory Agency (MHRA), which showed several deficiencies in the safety reporting systems at Roche Registration LTD. It showed that Roche had not evaluated information it had received to determine whether or not the same constituted adverse reactions which would need to be reported to the competent authorities in the EU. Roche callously put patient care and safety in the back seat of the profit mobile.
We are not talking about a few reports that Roche did not have time to follow up on. At the time of the inspection, Roche identified some 80,000 reports that had not been evaluated to determine whether or not they should be reported as suspected adverse reactions. More astounding is that these reports included 15,161 reports of patient deaths.
For the worldwide pharmaceutical companies, Europe is the old west’s Hole-in-the Wall where they hide out from the law.