The Japanese government recently issued a so-called business improvement order to Celgene for failing to report more than 4,500 side effect cases for three of its drugs.
Specifically, the company did not tell the Pharmaceuticals and Medical Devices Agency about side effect reports relating to three cancer drugs — Revlimid, Pomalyst, and Lenadex — going back to 2010, when Revlimid was first approved in the country. Side effect reports are required to be filed within 15 days, or 30 days after patient reactions are noted.
The order, which was issued on March 15 by the Ministry of Health, Labor, and Welfare, was first reported by Japan Pharma and confirmed by a Celgene spokesman.
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