Japan's regulator censures Japanese unit of Novartis for failing to report drug side effects

Published: 10-Dec-2015

A Chinese drug manufacturing facility run by Pfizer in China is also under scrutiny by the US FDA

Japan's health ministry is to censure a Japanese unit of Swiss pharmaceutical giant Novartis for failing to report serious side effects from some of its drugs within a certain period of time.

The case relates to side effects observed in around 5,500 patients, which should have been reported to the state within a few weeks of discovery. It is the third administrative penalty to be imposed on the company over its reporting delays.

The ministry said the drugmaker had told it that the delay was due to an in-house system failure that occurred at the beginning of last year.

Novartis was handed a 15-day business suspension order in February 2015, and a business improvement order in July 2014, for failing to report health problems caused by its leukaemia drugs by the deadline.

The same month, Novartis and a former employee were indicted on charges of causing a medical research team to release manipulated data in favour of the company’s blood pressure-lowering drug Diovan in 2011.

Pharmaceutical firms are required by law to report to the state significant side effects of their drugs within 30 days of discovery.

Similarly, a Chinese drug manufacturing facility run by Pfizer is under scrutiny by the US FDA after regulators discovered the use of expired materials and a second set of quality and manufacturing records that did not match official documentation, according to news agencies.

Pfizer said the issues raised in the FDA reports do not have 'any impact' on products currently available to patients.

Citing a FDA Form 483 submitted to Pfizer, during an inspection of the facility, regulators said employees 'hid quality failures, used expired manufacturing materials or ones that hadn’t been recently checked, and retested failing products until they passed'.

In its report, the FDA noted that some tests conducted at the Pfizer facility were re-run multiple times in order to attain favourable results if the original testing failed.

The FDA report highlighted a number of concerns, including site employees moving documents around during the inspection period and placing them in odd locations, including a wooden crate in a construction area on an upper floor. The documents that regulators noted were moved were manufacturing documents that included batch numbers, temperature and humidity conditions and manufacturing yield.

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