Justice Minister Nominee Kim Seung-won has repeatedly denied allegations that he lobbied for the approval of clinical trials for a new drug.

Kim's confirmation preparation team released a statement today (Sept. 5), explaining, "Some media outlets claim that the nominee engaged in 'poison lobbying,' but this distorts the facts and the parties responsible."

The nominee's side asserted that Kim was unaware that Genencel, the pharmaceutical company involved in the allegations, had omitted and fabricated animal testing data, and added that the approval process for the clinical trial plan was not unusually fast.

Kim's team stated, "After reviewing data showing that treatment effects were observed up to Phase 2 of overseas clinical trials, we simply forwarded a grievance to the Minister of Food and Drug Safety to ensure that the clinical trial procedures for a domestically developed treatment were not unfairly delayed."

They added, "The intent was not to demand drug approval or unconditional authorization, but to ask the Ministry of Food and Drug Safety (MFDS) to professionally review the submitted materials and make a fair judgment on whether to approve the clinical trial plan."

They further emphasized, "We did not know that [Genencel CEO] Kang had omitted and fabricated some animal testing data when submitting the materials, and it has not been confirmed that [Kim] was involved in such actions."

It was revealed that in October 2021, Nominee Kim asked Kim Gang-lip, then-Minister of Food and Drug Safety, to look favorably upon Genencel's application for clinical trials at the request of his long-time acquaintance Yang.

Two weeks later, the MFDS approved Genencel's clinical trials.

It was later discovered that Genencel had obtained clinical approval based on fraudulent reports that omitted information about the new drug's side effects, sparking controversy over whether Nominee Kim was involved in illicit lobbying.

Kim's side argued, "The essence of this matter is not the animal test results themselves, but the fact that Kang omitted and fabricated relevant data upon submission. Characterizing an independent criminal act by a company official retroactively as 'lobbying that secured the approval of a poisonous drug' is a malicious distortion."

Kim's team also dismissed claims that the MFDS review for Genencel was conducted at an unusually fast pace.

The confirmation preparation team stated, "According to official MFDS data, the review period for Genencel was 11 days, which is not faster than the average for new substance clinical trials, but rather took longer."

This was a rebuttal to claims made earlier by People Power Party lawmaker Han Ji-a, who asserted that the approval speed for Genencel's clinical trial plan was more than twice as fast as those for other COVID-19 treatments.

Lawmaker Han stated that based on data received from the MFDS regarding the "status of domestic clinical trial approvals for COVID-19 treatments from 2020 to 2022," clinical trial approvals for new substance-based COVID-19 treatments took an average of 71.6 days, whereas Genencel's was approved in 33 days.

She pointed out that the background behind the MFDS's unusually swift approval of Genencel should be clarified.

In response, Kim's side explained, "The 33 days is not the actual review period of the MFDS, but a simple elapsed period that includes the company's document supplementation period."

This 33-day span included the period from September 30, 2021, when the MFDS requested data supplementation, to October 18 of that year, when Genencel submitted the supplemented materials.

Kim's team countered, "The MFDS calculates and manages only the actual data review period as the 'MFDS required days,' excluding the company's supplementation period. Comparing a simple elapsed period—which includes varying supplementation periods for each company—with the actual review period of the MFDS to link it to preferential treatment is a flawed comparison benchmark."

(Photo: Yonhap News)