Japan hits Pfizer with business improvement order after ADR reporting failures

By Gareth Macdonald contact

- Last updated on GMT

Pfizer HQ in Japan
Pfizer HQ in Japan

Related tags: Adverse drug reaction

Pfizer failed to report hundreds of serious adverse drug reactions (ADRs) in the required timeframes according to Japan’s Ministry of Health, Labor and Welfare (MHLW) which has issued the US firm with a business improvement order.

The MHLW order [below in Japanese] states that, since 2008, Pfizer has failed to report 212 ADRs within the timeframes required by the Pharmaceuticals and Medical Devices Law (PMDL).

Under the law​, pharmaceutical companies have seven days to report ADR that cause, or are likey to cause, death. They have 15-days to report ADRs that result in hospitalisation, disability or serious medical conditions.

The Japanese regulator said Pfizer must revise its internal side effect monitoring and reporting procedures and retain staff, but stopped short of ordering the firm to cease manufacturing or selling its drugs in the country.

This was confirmed by a Pfizer spokesman, who told us “There’s no order to cease manufacture or provision of medicines in Japan.​"

Earlier this year​ Novartis was told to stop making and selling drugs in Japan for 15 days after an investigation revealed it had failed to report more than 3,000 ADRs within the required timeframes.

11 drugs

According to Pfizer’s Japanese website​ the drugs involved were Sutent,  Torisel , Inlyta , Toviaz , Rheumatrex , Zyvox , Enbrel, Xalkori, Vfend, Prodif and Lyrica. 

Pfizer said the investigation began on February 2 after it informed the MHLW that adverse events caused by some of its cancer drugs may not have been reported as per the legal requirements.

No labelling changes

Pfizer is already taking steps according to the spokesman, who told us “Pfizer Japan shall improve certain business operation procedures regarding safety reporting, and provide a re-training to all company employees to ensure that they understand their obligations regarding adverse event reporting.”

He added that: "For each of the products involved, Pfizer conducted an evaluation of the potential impact of the previously unreported information on the products’ safety profiles​.

"The outcome of this evaluation was that the risk-benefit assessment remained positive for each product and no changes to the respective product labeling are warranted​."

Related topics: Regulatory & Safety, Regulations

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