Novartis Japan unit faces business suspension order

The Japanese government plans to order a suspension of 15 days for the Novartis unit in Japan, accusing the drug maker of failing to report thousands of side effects associated with its medicines, according to Japanese media reports. A Novartis spokeswoman says the Japanese unit received a notice from the Japanese Ministry of Health, Labor and Welfare, but she did not offer details about the reasons for a suspension. 

The move marks the first time that a drug maker would receive such an order from the Japanese government for failing to report serious side effects, according to The Japan Times. Novartis received a so-called business improvement order last July over the side effect flap, which was first reported by the drug maker in June following an internal probe. More than 3,200 side effect cases were not reported, the paper notes. 

The Novartis unit in Japan “will take all necessary steps to ensure that Japanese patients are not adversely affected by any proposed business suspension order,” the Novartis spokeswoman says. “While we would need to evaluate the details of any proposed order from the [ministry], we believe that the financial impact will be manageable.” 

As reported previously, Novartis last summer acknowledged its staff hid side effect reports concerning patients who participated in clinical studies and evidence had been shredded or online files deleted. Japanese media reports indicated the drug maker was aware as early as April 2013 of the side effect cases, but reports are required to be filed within 15 days, or 30 days after patient reactions are noted, depending upon the seriousness of the adverse event. (Más)

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