Novartis faces suspension in Japan after series of trial data scandals

SINGAPORE--Japan plans to temporarily suspend Novartis' ($NVS) pharma business in that country, according to media reports. The Ministry of Health, Labour and Welfare's order will last about 15 days and will cite repeated violations of failure to report adverse events properly, the Japan Times says.

It will be the first time Japanese officials suspend a pharma company for failing to report side effects promptly, the Times says. Novartis Japan K.K. may be given an opportunity to explain before the suspension is finalized.

It's the latest punishment for Novartis' scandal-plagued unit in Japan. The Swiss drugmaker has weathered a chain of scandals over retracted Diovan trials, data-tampering allegations, false advertising charges, and internal investigations. Novartis cleaned house, replacing its top management in the country and adding remedial training for employees.

Novartis spokesman Eric Althoff told FiercePharma by email he could not immediately confirm the suspension and therefore had no comment. The ministry had not posted information about the suspension on its website as of press time and did not respond to requests for comment.

A major scandal erupted in April last year when Novartis failed to report the side effects of leukemia drugs Tasigna and Gleevec. Ten serious cases of side effects, which surfaced as the company collected data on 3,000 patients under leukemia treatments, were not reported as required by law, the Times says.

This side-effects scandal came soon after Novartis staff members and sales reps faced allegations of serious misconduct in a trial of its leukemia drug Tasigna. Employees were accused of breaking trial protocols in data collection and patient privacy, and attempting to cover up their missteps by shredding and deleting documents. In July, the government ordered Novartis to improve business practices and clean up its act in.

The company was already facing charges of exaggerated advertising for the blood-pressure remedy Diovan, by citing data from questionable and possibly fabricated data in promoting the drug. Academic researchers had already retracted at least two Diovan trials after evidence of potential data-tampering surfaced.

- see the Japan Times story

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