Seoul Central District Court and Seoul Administrative Court show a difference in responsibility of the Ministry of Food and Drug Safety
Kolon Life Science’s first trial of a criminal/administrative trial involving Invossakeiju, a gene therapy for osteoarthritis, ended with conflicting results.
In the two trials, the court’s judgment on the verification process of the Ministry of Food and Drug Safety (Director Kang-rip Kim) is mixed, and interest is drawn.
On the morning of the 19th, the Seoul Central District Court sentenced two executives of Kolon Life Sciences not guilty to charges of interfering with the execution of hierarchical public affairs, fraud and violation of the Subsidy Act under the Aggravated Punishment Act for certain economic crimes.
They were charged with filing false data for Invossa’s KFDA approval.
In response, the Seoul Central District Court stated that Kolon Life Sciences did not conform to some facts in the data, but pointed out that it is suspected that the KFDA lacked the verification process during the product approval process.
In other words, even if a pharmaceutical company submitted false data, it was determined that the KFDA should have confirmed it through thorough verification.
However, in an administrative lawsuit that took place on the same afternoon, the KFDA’s responsibilities were viewed differently.
The Seoul Administrative Court dismissed the claim of the plaintiff, Kolon Life Sciences, in a lawsuit for canceling the disposition of permission for manufacturing and selling items filed against the KFDA by Kolon Life Sciences.
The Ministry of Justice of the Administrative Court said, “Kolon Life Sciences did not properly inform the Ministry of Food and Drug Safety, so the opportunity to correct the truth and safety of Invossa’s gastric juice was lost. There is no offense in what I did.”
According to the decision in the afternoon, unlike the Seoul Central District Court, the Seoul Administrative Court judged that the Ministry of Food and Drug Safety could not properly verify the information due to the bias.
As the two rulings issued in the morning and afternoon showed different perspectives on the case, both the Ministry of Food and Drug Safety and Kolon Life Sciences carefully settled their positions.
An official from the Ministry of Food and Drug Safety said, “There is no special comment on the current Invossa related ruling.”
The legal representative of the Ministry of Food and Drug Safety said, “We are carefully concluding opinions with the department in charge of the Ministry of Food and Drug Safety on the results of the trial, and we will announce the relevant position later.
An official from Kolon Life Science said, “We are working to understand the overall situation. We will respect the judgment of the judiciary regarding criminal judgments, and we will consider possible countermeasures at the company level in the future for administrative lawsuits.”
The legal representative of Kolon Life Science said, “We are carefully considering the results of the conflicting trial and are preparing our position on countermeasures.”
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