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UK Regulators Question Roche Safety Reporting

Filed June 22nd, 2012 Laurie

On Thursday, the U.K.’s medicines regulatory agency, the MHRA, said it is investigating how Swiss drug maker Roche Holding AG reports the safety of its drugs after U.K. found deficiencies during a routine check.

The problems appeared after the MHRA inspected the company as part of a coordinated European program of assessing drug safety reporting systems. The investigation found that Roche had failed to properly evaluate some of 80,000 reports linked to a company-sponsored patient support program in the U.S. to determine if they should be reported as suspected adverse events – including 15,161 reports of patient deaths.

“It is not known whether the deaths were due to natural progression of the disease or had a causal link to the medicine. More recent information from the company indicates a smaller number of reports, but this information needs to be verified by the authorities,” the European Medicines Agency said in a statement.

The agency said there did not currently appear to be evidence of a negative impact for patients.
Roche acknowledged that it had not fully complied with regulations on safety reporting, but it was working towards remedying the problem.

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