By Peter Landers
TOKYO--Health authorities ordered the Japanese unit of Novartis
AG to shut down most operations for 15 days in March, saying the
drug maker failed to report side effects from its products in a
timely fashion.
The order by Japan's Ministry of Health, Labor and Welfare,
issued Friday, said Novartis Japan must halt production and sale of
its drugs from March 5 to March 19. Five drugs were excluded from
the order because of the potential harm to patients if supplies
fell short.
The ministry said Novartis Japan failed to report 3,264 cases of
side effects involving 26 drugs within the period required by law.
It said the case was the first time the ministry had issued a
suspension over failure to report side effects.
Novartis Japan said it accepted the punishment. It apologized to
patients and doctors for "causing trouble and worry." The company
said that after reviewing the side-effect reports, it didn't find
any that would necessitate changing safety information on drug
labels.
The company said it has bolstered education of employees to
ensure that safety reports are submitted properly.
The suspension is the latest blow to the Swiss drug maker's
business in Japan. Last July, prosecutors brought charges against
Novartis Japan and a former employee related to allegations that
data in a clinical trial were falsified. Novartis said at the time
that it hadn't found evidence of willful manipulation or
falsification of data. In April 2014, Novartis replaced its top
management in Japan.
Write to Peter Landers at peter.landers@wsj.com
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