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Japan Plans to Suspend Novartis From Doing Business in the Country

February 9, 2015

Japanese regulators have notified Novartis Pharma K.K., the Japanese arm of the Swiss drug giant, that they are planning to temporarily suspend the firm from doing business in the country.

Novartis acknowledged receiving notice of the planned suspension, but declined to elaborate on the reasons for it. Japanese media reports say the move by the government is punishment for the company failing to report thousands of side effects associated with its drugs, and that the suspension will likely last 15 days.

The proposed suspension must be approved by the health ministry, and the company will have an opportunity to defend itself before it is imposed.

Novartis spokeswoman Julie Masow said the drugmaker will be able to handle the financial impact of the suspension and is making plans to help its patients avoid any problems stemming from the interruption of business.

Novartis’ recent history in Japan has been shaky. Early last year, Japan’s Ministry of Health, Labour and Welfare filed charges against the company for using falsified clinical data to support marketing for blood pressure drug Diovan (valsartan), marketed as Valturna in the U.S.

In 2013, the Department of Justice accused Novartis of treating doctors to business meetings, Florida fishing trips and lavish dinners to promote Valturna, calcium channel blocker Lotrel (amlodipine besylate/benazepril HCl) and its diabetes drug Starlix (nateglinide). — Lena Freund