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Roche Pharmaceutical may face fines if charged with allegations of not properly researching medication side effects. If charged with these allegations, Roche could be fined up to five percent of their 13.8 billion European Union turnover.
The investigation began during a routine inspection in June, when the Swiss based company was found to have failed to adequately assess 80,000 cases of adverse drug side effects.
More recently, The European Medicines Agency (EMA) has begun an infringement procedure against Roche alleging the possibility of pharmaceutical injury and that the company has not complied with its legal obligations. The pharmaceutical company was part of a reimbursement program that helps United States patients pay for Roche’s drugs that they otherwise could not afford.
Of the 80,000 reported cases, 15,000 deaths were reported. Those tragic deaths, which may have linked to the drugs, prompted the immediate investigation. The issue of drug safety reporting will need further research to determine if the deaths of the patients were immediately related to the Roche drugs.
Roche is cooperating in the investigation and claims that to date no impact on the safety of any of its products has been found. They also state that there has been no indication of negative impacts on the benefit- risk balance to patients.
A Pharmaceutical injury is not your fault. Patients must know their rights and stand up against neglectful actions. If you or someone you know has been adversely affected by prescription medications, contact Sacramento Pharmaceutical Attorney, Frank D. Penny today.
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