Roche Report on Lax Drug Safety Reporting Issued by the European Medicines Agency

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The European Medicines Agency (EMA) has announced that it has finalized its probe into the drug maker, Roche, and potentially lax drug safety reporting issues. The EMA report has been sent, for next steps, to the European Commission.

The European Commission will make a decision concerning if the matter should be pursued and if any financial penalties, which may be significant, will be assessed, according to Reuters. Reuters reported that Roche may have breached EU rules; however, due to confidentiality, no further details have been provided.

In November, the EMA indicated that it had not discovered new safety issues associated with Roche drugs over shortcomings in how adverse events are reported. The probe was initiated in 2012 after a routine investigation found that Roche had not appropriately assessed tens of thousands of cases of possible adverse drug reactions. The Roche 19 drugs involved included several that are used to treat cancer, Reuters noted.

Drug makers must evaluate issues concerning their drugs that are reported by physicians and patients; serious cases must be reported to regulators. If Roche is found to have failed to comply with its ‚Äúpharmacovigilance‚ÄĚ obligations under EU rules, it may be subject to up to 5 percent of its yearly EU turnover, some 12.8 billion Swiss francs, or $14.6 billion in United States dollars, according to Reuters. The pharmacovigilance inspection conducted by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) took place in 2012 and identified significant issues in Roche‚Äôs pharmacovigilance processes, according to The Pharma Letter.

The inquiry involves Swiss drug maker Roche’s, Roche Registration Ltd., involving, according to the EMA, an infringement procedure against the drug maker, wrote The Pharma Letter. The agency initiated the probe at the European Commission’s request over allegations that Roche did not comply with its pharmacovigilance obligations concerning the 19 centrally authorized Roche medicines.

Cancer medications are very strong drugs used to treat very vulnerable patients who suffer from dangerous and life-threatening diseases. Additional or unexpected adverse drug reactions may lead to significant, deadly consequences in people who are diagnosed and who are being treated for cancer. In order for physicians and patients to make informed decisions about drug therapy, it is imperative that full disclosure on drug safety and efficacy be provided.

Parker Waichman LLP has long supported efforts to protect whistleblowers. If you believe that your employer is committing fraudulent activities and would like to maintain your anonymity, or are seeking protection from retaliation by your employer, we encourage you to contact us as, well. Free case evaluations are also available by calling 1-800-LAW-INFO (1-800-529-4636).