TThe Ministry of Food and Drug Safety Tuesday decided to cancel the license of Kolon Life Science’s gene therapy drug Invossa and file and file criminal charges against the company. Less than two years ago, Invossa had received the approval as the first gene therapy treatment for osteoarthritis in Korea.
After its investigation that lasted over 50 days, the Food and Drug Ministry found that unlike the data submitted by the Kolon Life Science, one of the main ingredients of Invossa was not cartilage cells but kidney cells, which are known to have the risk of causing cancer. The drugmaker intentionally concealed problems with the drug it discovered before submitting the data for approval.
The world’s first gene therapy drug for osteoarthritis developed by the Korean drugmaker drew the international attention two years ago but its license has eventually been revoked. It might take a toll on the domestic biopharmaceutical market. Above all, the safety of some 3,700 patients, who have already taken the drug, should come first. The ministry should do everything possible to take care of the patients and conduct a follow-up survey for the next 15 years.
This scandal raises awareness on the heavy toll the dishonesty and moral hazard of the bio industry takes on people’s lives. Being obsessed with earning the title such as “country’s first” and “world’s first,” Kolon Life Science concealed the possibility of the drug’s ingredient causing cancer. The company has lost credibility and has to worry about its survival now. Stock trading of relevant companies was halted Tuesday and some patients, who have taken Invossa, are preparing for a class action against the company.
The scandal has revealed the lax management of the approval system as well. The drug authorities should be held accountable for giving the green light without conducting a thorough verification. It should be investigated whether the approval process was inappropriate.
Restoring trust in the bio-health industry is an important national task for a country looking for future growth engines. On last Wednesday, the government designated three new target growth engines including bio-health, non-memory chips, and future mobility, while announcing its plan to invest 4 trillion won in research and development every year. We should not let this scandal be another trauma for the bio-health industry after the Hwang Woo-suk sandal hit the Korean bio industry hard. People in the industry should develop a sense of duty and ethics, keeping in mind that they deal with people’s lives. For the ministry’s part, it should designate personnel who will take charge of the entire approval process, including development, approval, manufacturing, and usage, and strengthen their expertise.