Minister Kim Seung-won, the nominee for the Ministry of Justice, again denied the "new drug clinical trial lobbying allegations." Kim said he did not know that drugmaker Genencell had omitted or falsified animal test data, and that the speed of approval for the clinical trial plan was not unusually fast.
Kim's confirmation hearing preparation team said in a notice to the press on Sept. 5 that "according to official data from the Ministery of Food and Drug Safety, Genencell's review took 11 days, and it actually took longer than the average for new-substance clinical trials, not faster."
This refuted a claim by Han Ji-a of the People Power Party that approval for Genencell's clinical trial plan was more than twice as fast as for other COVID-19 treatments. Han said approval for clinical trial plans for COVID-19 treatments based on new substances took an average of 71.6 days, but Genencell was approved in 33 days.
Kim said the 33 days was not the Ministery of Food and Drug Safety's actual review time, but simply elapsed days including the company's period for supplementing materials. He said the 33 days spanned from Sept. 30, 2021, when the agency requested supplementary data, to Oct. 18, when the supplemental materials were submitted.
Kim added, "The Ministery of Food and Drug Safety calculated and managed only the actual document review period as the 'agency review days,' excluding the company's supplement period," and argued, "It is wrong to link alleged favors by comparing the agency's actual review period with simple elapsed days that include supplement periods, which vary by company, because the comparison baseline itself is flawed."
He also said he did not know that animal test data had been omitted or falsified before submission. He explained, "I did not know that (Genencell CEO) a person surnamed Kang omitted or falsified some animal test data before submitting it, and it has not been confirmed that I was involved."
He continued, "The essence of this matter is not the animal test results themselves, but that Kang omitted or falsified related data before submitting it," and argued, "Retroactively labeling an employee's independent criminal conduct as 'lobbying that secured approval for a poison' for the nominee is a malicious distortion."
Earlier, it emerged that in Oct. 2021 Kim, at the request of a person surnamed Yang, asked then-head of the Ministery of Food and Drug Safety Kim Gang-lip to "please keep an eye on" Genencell's clinical trial application. Afterward, it was revealed that Genencell secured a patent decision and obtained clinical approval based on a false experiment report, prompting allegations that Kim was involved in improper influence-peddling and lobbying.
Kim said, "After reviewing materials indicating therapeutic effects up to phase 2 overseas clinical trials, I simply conveyed a grievance petition to the head of the Ministery of Food and Drug Safety so that the clinical trial process for a domestically developed treatment would not be unduly delayed."