Team says pre-consultation with drug safety agency was already underway before Kim Seung-won made contact
The confirmation hearing preparation team for Justice Minister Nominee Kim Seung-won rebuffed allegations that his phone call to the head of the drug safety agency had accelerated approval of a COVID-19 treatment's clinical trial, saying the claim "is not true."
In a statement released Thursday afternoon, the team said that Genecell — the pharmaceutical company at the center of the controversy — had been in pre-consultation with the Ministry of Food and Drug Safety through the agency's official pre-consultation system since June 2021, months before Kim made contact on Oct. 12, 2021. A preliminary meeting on the phase 2 and 3 clinical trials was also held at the ministry's public service office on June 23 of that year, the team said.
The team said the formal investigational new drug application was submitted on Sept. 23, 2021, following a preliminary review by the ministry's case officer. The ministry then requested supplementary materials on Sept. 30, received the final submission on Oct. 18, and granted approval on Oct. 26. "At the time, COVID-19 treatments were subject to an expedited review program requiring processing within 15 days of receiving supplementary materials, and the approval in this case was completed within that standard timeframe," the team said.
The team doubled down, saying the approval "was not expedited by Kim's contact, but was carried out through the ministry's official procedures that had been in progress for several months."
Kim had previously been investigated by prosecutors over allegations that in October 2021, at the request of an acquaintance surnamed Yang, he asked then-Ministry of Food and Drug Safety Commissioner Kim Kang-rip to expedite work related to the clinical trial of a COVID-19 treatment being developed by Genecell. The allegations resurfaced after Kim was recently nominated as justice minister. The prosecution team at the Seoul Western District Prosecutors Office handling the case issued a suspension of indictment in December 2024, and Kim filed a constitutional complaint with the Constitutional Court in May last year, arguing the decision was unjust.
The controversy deepened as more specific details of the alleged lobbying emerged. Independent Lawmaker Han Dong-hoon cited on Wednesday, via his social media account, the text message Kim allegedly sent to then-Commissioner Kim Kang-rip on Oct. 12, 2021. Han said he was posing a public question to the nominee, asking whether Kim had sent a message reading: "I'm told the work is divided among three offices — the Herbal Medicine Division, the Clinical Trial System Division, and the Statistical Analysis Team. Please ask the staff in charge to process this quickly. The company is Genecell. I mentioned this because I was also concerned about capital flight. Thank you, Commissioner" — in an effort to help secure clinical trial approval for Genecell's COVID-19 treatment.
Kim arrived Thursday morning at the confirmation hearing preparation office in Jongno-gu, Seoul, for the first time and addressed the allegations. "Prosecutors mobilized more than 10 prosecutors over three years starting in 2021 and conducted an extremely intensive investigation, and they decided not to indict," he said. "The reason was, first, that it was difficult to view this as an improper solicitation, and second, that there was no wrongdoing — no preferential treatment, no special favors, no bypassing of procedures — in the clinical trial approval process."
He then said, "So that part should rightfully have been cleared entirely, but they issued a suspension of indictment on the grounds that I introduced a way to provide support — I believe that was also unjust, which is why I filed a constitutional complaint last year against the suspension of indictment, and I understand the Constitutional Court is reviewing the case." He added, "I want to clear my name on this, no matter what."
yg@heraldcorp.com
