The Ministry of Food and Drug Safety said it would investigate the safety issue of Kolon Life Science’s arthritis drug Invossa-K with all possibilities open, even though the company said the injection was safe.
Depending on the timing of the cells being mislabeled and intentionality, the pharmaceutical firm will face a different level of administrative or criminal punishment, it said.
Kolon has voluntarily asked an American testing institution to analyze the cell ingredients of Invossa for the Korean market distribution, and the outcome is expected to be released on April 15.
On Monday, Kolon said the cancerous cell lines used for clinical trials of Invossa in the U.S. were found to be identical to those made and distributed in Korea, in an interim analysis report. However, the ministry said, the interim result did not clarify the entire process of the misidentification of the cell lines.
The report only confirmed that the cells in the U.S. were identical to those in Korea and did not demonstrate why the cells have been mislabeled. It cannot be a valid basis for checking the company’s intentionality, the ministry said.
The regulatory agency said it would open all the possibilities to confirm how Invossa cells were mislabeled and whether Kolon’s allegations were true.
The cell lines could have been kidney-derived cells from scratch, as Kolon claims. Another possibility is that the cells could have been replaced in the middle of clinical trials, or the process of drug approval. Still another possible scenario is that data could have been fabricated from the drug approval stage.
“Kolon Life Science’s interim result only showed that the working cell bank for U.S. trials was the same as that for sale in Korea. The ministry is investigating everything from reviewing submitted data to testing cells. We have to identify what happened in which stage,” a ministry official said.
Administrative measures can vary depending on whether there was no problem during approval, but the cells were mislabeled after approval, and whether the mislabeling occurred before or after the start of the clinical trials, he said.
“It all depends on whether the company made a wrong decision at which stage, and which law was violated,” the official said. “As the cause is still unknown, we cannot predict any administrative measure or criminal penalty.”
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