Takeda Responds to Japanese Regulatory Authorities on Promotional MaterialsBy
Takeda Pharmaceutical Company Limited has received an order to improve business operation from the Japanese Ministry of Health Labor and Welfare (MHLW) based on the decision that two promotional materials targeting healthcare professionals for the hypertension medicine Blopress (candesartan cilexetil), which was developed in 2006 and 2010 based on results from the investigator-led CASE-J clinical research, are applicable as misleading advertisements prohibited under Article 66, Paragraph 1 in the Pharmaceutical and Medical Device Act (PMD Act) of Japan.
In a statement, Takeda said that the order does not raise any questions on Blopress' proven safety and efficacy in lowering blood pressure. “However, Takeda sincerely regrets receiving this order to improve business operation due to misleading advertisements, and sincerely apologizes to patients, healthcare professionals, and all concerned parties for the concern caused by this event,” said the company in the statement.
This order is based on the judgment by the MHLW that Takeda inappropriately emphasized expressions in promotional materials for healthcare professionals regarding secondary effects of medicine to control cardiovascular events and diabetes. Accordingly, MHLW requests Takeda to strengthen the review system for materials, including advertisements, and to enhance the training program for employees and senior managers responsible for the process of developing and reviewing materials in Japan.
Takeda said it has already introduced enhanced review and management structures for controlling promotional materials to prevent similar incidents, in response to the changing social environment and regulations in Japan. “The company takes this order to improve business operation by the MHLW very seriously, and will continuously enforce necessary preventive measures,” said the company in statement.
Source: Takeda Pharmaceutical