A civic group said the Ministry of Food and Drug Safety should be held accountable for the abrupt suspension of Invossa-K Inj., a treatment for degenerative arthritis by Kolon Life Science.
It criticized the ministry for approving the sale of the drug as the nation’s first gene therapy without identifying the ingredients accurately.
“For about 11 years from the initial clinical trial to the sales, the food and drug safety ministry has been unaware of the mislabeling of the Inovossa’s ingredients. This is clear neglect of duty,” Citizens' Coalition for Economic Justice said in a statement, Tuesday.
The U.S. Food and Drug Administration found the mishap first, and Kolon Life Science’s voluntary reporting has revealed the issue, the group said. “The FDA found that the ingredients were different in the clinical trial stage, but Korea’s food and drug safety ministry did not know even after granting the marketing license,” it added.
The civic group argued that it was evident that the ministry poorly managed and supervised drug ingredients during the clinical trials and approval process.
“The food and drug safety ministry did not even know about what kind of side effects the correction of the ingredients’ names from cartilage-derived cells to kidney-derived cells would cause, and it was irresponsible for the ignorance,” the group went on to say.
The ministry was irresponsible to say in a press release that there would be no safety concerns because there was no side effect reported during the past 11 years, it added.
The civic group also claimed that the government should review putting the food and drug safety ministry under the Ministry of Health and Welfare, questioning its function.
The activists’ group also demanded the authorities thoroughly investigate whether Kolon Life Science had known that kidney-derived cells were mixed in Invossa from the clinical trial to the final licensing approval and whether any mixture had changed the ingredients.
“The investigation should be made not only upon the company but on the food and drug safety ministry if the ministry tried to cover up the truth, to promote the drug’s ‘world’s first’ title,” it said.
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