Novartis Facing Suspension in Japan for Rampant Illegal Activity

In a precedent-setting regulatory action by the Japanese Ministry of Health, Labor, and Welfare, Novartis’ pharmaceutical business is facing suspension in that country after committing repeated legal violations, including false advertising, clinical trial failures, and illegal reporting delays. This is the first time the Japanese health ministry will take disciplinary action of this kind against a pharmaceutical company, which comes after a series of company scandals over the past several years. In April 2014, the company was accused of failing to meet its legal reporting requirements by not submitting adverse reactions to its Tasigna and Gleevec leukemia drugs. The company also faced allegations of serious misconduct in its Tasigna clinical trials, including breach of protocol and patient privacy, as well as destroying documents in an attempted cover-up. The drugmaker may have also fabricated or tampered with data in the promotion of its Diovan drug in a false advertising scheme. The decision by the Japanese health ministry to crack down on rampant illegal activity by Novartis potentially signals a greater focus on safety in the country’s pharmaceutical industry, protecting future consumers from serious health risks.

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