Japan's Ministry of Health, Labor and Welfare is planning to slap the Japanese unit of Novartis ($NVS) with a "business improvement order" for failing to properly disclose serious side effects of some of its drugs, the Japan Times is reporting.
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| Novartis CEO Joe Jimenez |
Unnamed sources cited by the newspaper said the case revolved around side effects in 5,500 patients that should have been reported within 30 days of discovery, according to Japanese law, the paper reported.
This is the third time the Japan unit, Novartis Pharma K.K., has been slapped with penalties over "reporting delays," the Japan Times reported.
Ministry officials told the newspaper that Novartis blamed the reporting delay on an "in-house system failure" at the beginning of 2015.
The Japan Times said Novartis Pharma was hit with a 15-day suspension in February and was earlier hit with a business improvement order in 2014 for failing to report problems with its leukemia drugs.
Also in 2014, the Japanese unit and a former employee were indicted for "causing a medical research team to release manipulated data" related to the company's blood-pressure drug Diovan in 2011.
- here's the story from the Japan Times