Novartis hit with 15-day suspension over omission of adverse events reporting

Swiss drug major Novartis (NOVN: VX) has been ordered to suspend operations in Japan for 15 days as of March 5, the first penalty of its kind for a pharma company in Japan.

The company has been under threat of such a suspension after receiving a notice from the Japanese Ministry of Health, Labor and Welfare. The penalty was prompted by Novartis admitting in December that it failed to promptly report the adverse events that occurred in 3,000 cases in over 20 of its drugs. Novartis has accepted the penalty, apologizing to patients and physicians for "causing trouble and worry." It said that after reviewing the side-effect reports, it didn't find any that would necessitate changing labels.

Novartis’ Japanese operations have been hit by problems in the recent past, as authorities said they  would charge the company and a former employee for manipulating trial data around Diovan (valsartan).