Novartis faces 15-day suspension by Japanese health ministry
The drugmaker confirmed to in-Pharmatechnologist.com Novartis Pharma KK has received a pre-notification from the Ministry of Health, Labor and Welfare (MHLW) of a Business Suspension Order.
The suspension will last around 15 days, according to sources cited by local news agency Kyodo.
“NPKK will take all necessary steps to ensure that Japanese patients are not adversely affected by any proposed Business Suspension Order,” said Novartis.
“While we would need to evaluate the details of any proposed Business Suspension Order from the MHLW, we believe that the financial impact will be manageable.”
The company did not comment on reports the suspension is because it omitted to declare adverse drug effects. It also did not answer questions about which therapies were involved, or whether the sanction is linked to previous failures to report side effects.
Novartis received a Business Improvement Order in July last year, after the company underreported side effects of leukaemia drugs Tasigna and Glivec.
An internal investigation found the company had blurred the lines between R&D and sales operations in Japan, and Novartis Sales staff had destroyed evidence about adverse effects of the drugs. David Epstein, head of Novartis Pharmaceuticals, called the behaviour “unacceptable” and replaced the President of Novartis Holdings Japan and the heads of Japan’s pharma and oncology divisions.
In February 2014, MHLW accused Novartis of manipulating data for blood pressure drug Diovan and raided the company’s Tokyo office.
