Japanese lawmakers are stepping in to Diovan investigation

7 October 2013

Members of Japan’s Diet (Congressmen) have formed a bipartisan study group to examine Swiss drug major Novartis’ (NOVN: VX) now off-patent blockbuster blood pressure drug Diovan (valsartan) conflict of interest trial (The Pharma Letter July 15), reports TPL’s local analyst.

The voluntary group of lawmakers scheduled a meeting in the Diet on October 26 and called officials of the Ministry of Health, Labor and Welfare (MHLW) to explain its interim report on the Diovan scandal compiled last week.

The lawmakers are focusing on defectiveness of the system for “investigator initiated trials.” The MHLW in 2003 institutionalized the investigator initiated trials that should be conducted by medical doctors without sponsorship from pharmaceutical companies. In order to promote the independent trials, the Ministry in 2005 set out various guidelines including one for conflict of interest.

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