The health ministry will investigate the Japanese unit of Novartis AG, Japanese media said Tuesday, after a ministry panel said it may have violated Japanese law when it cited studies based on manipulated data to promote its blood pressure drug Diovan.
“Japan, as a part of its growth strategy, is pushing for high-quality clinical studies necessary to develop pharmaceuticals originating in Japan,” a ministry investigative committee said in a draft interim report.
“This is a grave matter that could harm the national interest by seriously damaging trust in Japanese clinical studies both domestically and overseas.”
The draft report called on the ministry to conduct on-site investigations at Novartis Pharma, the company’s Japanese arm, and look into whether it violated the Pharmaceutical Affairs Act. Kyodo and Jiji news agencies reported that the ministry planned to proceed with such investigations.
Several Japanese hospitals have stopped offering Diovan after two Japanese universities retracted papers regarding the drug’s efficacy in reducing the incidence of stroke and heart attack.
Novartis has said that a former employee who assisted in the trials had acted inappropriately but the report said the case involved the company, not just a single individual.
Novartis Pharma said in a statement following the report that it took the findings seriously and would cooperate with the ministry in its investigations, while offering its apologies to patients and those in the medical profession.
Japan is an important market for Novartis, accounting for around a quarter of Diovan’s global sales before the scandal. Novartis Pharma declined to disclose the impact on sales of the drug, whose patent is due to end in Japan later this year, allowing competition from generic copycats.