Kolon’s ‘innovative drug company’ status to be revoked
The Ministry of Health and Welfare said Wednesday that it is considering revoking Kolon Life Science’s certificate as an “innovative drug company” for its mislabeling and false reporting of a key ingredient in its gene therapy drug Invossa.
Invossa, the osteoarthritis gene therapy drug for patients with degenerative joint disease, was approved by the Ministry of Food and Drug Safety (MFDS) in 2017, based on the fact that the drug used cartilage-originated cells. However, the drug manufacturer instead produced and sold the drug made with a different material — cells originating from the kidney.
The certificate is given to a company which has had significant success in developing new drugs and expanding exports, in a government effort to boost the global competitiveness of local pharmaceutical firms. Such companies are provided with various administrative and financial support.
Under the relevant law, the health ministry is able to revoke the certification after holding a hearing if a drug manufacturer received the certificate via false and other illegal methods.
The ministry also said it plans to retrieve the 8.2 billion won ($7.02 million) in research and development subsidies jointly provided to Kolon Life Science by the health ministry and the Ministry of Science and ICT for three years since October 2015 when the company was selected for the government’s project for hightech biomedicine development.
Earlier this year, an investigation revealed the company falsely reported the ingredients and intentionally did not disclose additional data on the problem to the health authorities before the drug’s approval.
Upon final disclosure, the MFDS forced the company to stop manufacturing and selling the drug in March, and cancelled the license for the drug later.
More than 300 cases of Invossa side effects have been reported among about 3,000 people who had the drug administered to help with knee problems, according to data submitted to Rep. Jung Choun-sook of the ruling Democratic Party of Korea by the health ministry.