Japan unit of Novartis sees most sales suspended 15 days over ADR failures

SINGAPORE--Japan's health ministry on Friday told the local unit of Swiss-based Novartis ($NVS) to suspend most sales operations for about two weeks over an earlier failure to report drug side effects.

The 15-day suspension by Japan's Ministry of Health, Labor and Welfare is said by industry watchers to be a first for a multinational drug company operating in Japan. The suspension period starts from March 5, according to an email from the ministry.

Tokyo-based Novartis Pharma K.K. in December admitted it failed to promptly report more than 3,000 cases of adverse effects from about two dozen company drugs. Drugmakers are required to report serious side effects to the ministry within 15 to 30 days.

"We can confirm that Novartis Pharma KK (NPKK) has received a 15-day business suspension order from the Ministry of Health, Labor and Welfare (MHLW) for failure to report adverse events within the timeline specified under the Law on Pharmaceutical and Medical Devices," Novartis said in an emailed statement. "The delay in reporting was confirmed following an internal review. The MHLW has not requested NPKK to revise product inserts or implement safety measures in relation to the delayed reporting of these adverse reactions.

"Novartis takes this matter very seriously and we have been strengthening and expanding company-wide measures to ensure that such incidences do not recur. NPKK will take all necessary steps to ensure that patients in Japan are not adversely affected by the business suspension. Based on our assessment of the details of the order, we do not expect a material impact on our financial performance."

In July last year, Novartis received a business improvement order for failing to properly report side effects of two leukemia drugs.

Also in July prosecutors laid charges against the unit over claims that falsified data were used to exaggerate the benefits of a popular blood-pressure drug.

They also indicted a former employee, Nobuo Shirahashi, alleging he manipulated the data in clinical studies that were later used in marketing the drug Diovan. The drug's generic name is Valsartan.