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[222] 2019.06.05
Invossa Incident caused by Kolon’s Illicit Actions and the MFDS’s Terrible Approval System

Invossa Incident caused by Kolon’s Illicit Actions and the MFDS’s Terrible Approval System

- Patients Treated with Invossa Must be Immediately Found

In 2019, another unprecedented incident caused new fears and anxieties among consumers: the Ministry of Food and Drug Safety (MFDS) revoked the license of Invossa-K Inj. (hereinafter “Invossa”), the world’s first therapeutic drug for degenerative osteoarthritis developed by Kolon Life Science Inc. (hereinafter “Kolon”), after its belated acknowledgement of Kolon’s false data reporting. Nowadays, we consumers cannot even be sure of the reliability and safety of medicines due to Kolon’s deceptions and the MFDS’s incompetence.

Therefore, 11 member organizations of the Korean National Council of Consumer Organizations (KNCCO), due to their deep concern regarding the Invossa crisis, are urging emergency measures which are necessary for the safety of patients.

First, the government must use its best efforts to confirm a list of the patients treated with Invossa.

According to a press release from the MFDS[1], 3,707 local patients were administered with Invossa in 437 hospitals, among whom 1,040 subjects have registered[2] via the 245 medical institutes as of May 27, 2019. However, the number of the victims should be accurately confirmed for the purpose of investigations in relation to the criminal charges against Kolon and a civil class lawsuit of the patients. The hottest issues in this incident will be the specific amount of damages and proving causation; thus, it is important to find and to register the remaining 2,667 subjects in the system. The problem is that it is highly likely that the unregistered patients do not know they have been injected Invossa, or else they not know how and where they should report the damage. Hence, we can’t just keep waiting for the patients to appear by themselves. The medical institutes involved may also be avoiding active cooperation to find the subjects, since they may feel guilty for recommending and administering this expensive drug (KRW 5 to 7 million) not covered by the National Health Insurance to patients. Our demand is that the government of South Korea, instead of the health authorities, should enforce the demand for a list and information on all the patients treated with Invossa.

Second, a fair investigation and severe punishment against those in charge are the things most required for further improvement of the system.

The MFDS has promised that such an incident will never happen again due to the development of an advanced approval system with the appropriate solutions including patient safety measures. It is the MFDS’s duty to prevent such incidents threatening public health and safety. But the things we need to do first and foremost, which will lead to an actual enhancement of the system, are as follows: to accurately determine the instances of illegality; to identify who will take responsibility; and to impose a severe punishment to those in charge for their incompetence and violation of due diligence. Kolon falsely submitted data while the MFDS approved the drug based only on the documents filed by Kolon, without any other review or monitoring processes; thus, Kolon’s willful fraud and the MFDS’s gross negligence must have an equal share of the blame. They will learn from what they have done by a thorough investigation and disciplinary actions alone, which must be undertaken before developing further remedies if the government wants to inform the public of accurate facts, ease the consumers’ anxiety and restore public confidence.

Although there is nothing more important than people’s health, lives and safety, the media have focused on pointless issues such as the “World’s First Therapeutic Drug”, “Research Funds over KRW 10 Billion” and “Stock Prices” pertaining to the Invossa incident. What we have to remember is that thousands of civilians have suffered physically and mentally due to Kolon’s shameless misconduct and the MFDS’s ineptitude. Hence, we demand justice for the peoples – we demand that the government addresses our needs with a thorough investigation and disciplinary actions, as well as by developing an enhanced management/supervision system for the approval of foods and drugs.



[1] “MFDS Cancels the License of Invossa-K Inj. of Kolon Life Science”, press release from 05/28/19.

[2] The Korea Institute of Drug Safety & Risk Management (KIDS) recommends that patients treated with Invossa should enroll in the Pharmacodynamic Web-based Investigation System for a follow-up survey.







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