TOKYO, Jan 9 (Reuters) - Japan’s health ministry filed a criminal complaint against Novartis AG’s local unit on Thursday after the pharmaceuticals company promoted its best-selling blood pressure drug Diovan using manipulated data.
The complaint, filed with the Tokyo District Public Prosecutor’s Office, is the first in Japan brought solely on the basis of exaggerated advertising, banned under the pharmaceutical affairs law, a ministry official said.
Several Japanese hospitals stopped offering Diovan last year after two universities retracted papers on the drug’s efficacy for preventing strokes and heart disease.
The government’s move follows months of on-site investigations at Novartis Pharma, the Swiss drug giant’s local arm. The company admitted last year that an employee who assisted in the drug’s clinical trials had acted inappropriately, promising improved training and oversight procedures.
Japan is an important market for Novartis, accounting for around a quarter of Diovan’s global sales before the scandal. Annual sales of Diovan in Japan have topped 100 billion yen ($954 million) since 2005, according to Novartis Pharma.
Diovan’s patent expired in Japan last September, allowing competition from generic drugs. ($1 = 104.8350 Japanese yen) (Reporting by Chang-Ran Kim; Editing by Edmund Klamann)