'Expedited review program was in place during COVID-19'
Justice minister nominee Kim Seung-won has again denied allegations that he improperly lobbied for pharmaceutical company Genescel's COVID-19 treatment clinical trial application at the Ministry of Food and Drug Safety, saying the review took 11 days — not unusually short given the agency's target of 15 days or fewer at the time.
Kim's confirmation hearing preparation team said in a press notice Saturday that "according to official Ministry of Food and Drug Safety data, the review of Genescel's application took 11 days, which was not faster than the average for new-substance clinical trials — in fact, it took longer."
The statement directly rebuffed People Power Party lawmaker Han Ji-a, who had claimed the agency approved Genescel's clinical trial plan more than twice as fast as other COVID-19 treatments.
Han cited data obtained from the Ministry of Food and Drug Safety on domestic COVID-19 treatment clinical trial approvals from 2020 to 2022, which showed that approvals for new-substance COVID-19 treatments took an average of 71.6 days, while Genescel received approval in 33 days. Han called on the ministry to explain why its approval of Genescel had been unusually swift.
Kim's camp said the 33-day figure was not the ministry's actual review time but a simple elapsed period that included the time the company spent supplementing its documentation. The 33 days encompassed the period from Sept. 30, 2021, when the ministry requested additional materials, to Oct. 18 of that year, when Genescel submitted them.
"The Ministry of Food and Drug Safety calculated and tracked only the actual document review period — excluding the time companies spent on supplementation — as its official review duration," Kim's team said. "Comparing a simple elapsed period that includes each company's varying supplementation time against the ministry's actual review time, and then characterizing it as preferential treatment, is based on a fundamentally flawed standard."
The team added that under the ministry's "Go/Fast-Track Program," launched to support COVID-19 treatment and vaccine development, the target review period for new-substance clinical trials was 15 days or fewer, and Genescel was covered under that program.
"There is no basis whatsoever for the claim that Kim's contact changed the review order, altered the criteria, or led to any procedural shortcuts," the team said. "Reports that the review was twice as fast as average, or that it amounted to successful lobbying, ignore the ministry's official calculation standards and actual review procedures."
Kim contacted then-Ministry of Food and Drug Safety Commissioner Kim Gang-rip in October 2021 at the request of a longtime acquaintance surnamed Yang, asking him to take a close look at Genescel's clinical trial application.
Allegations of improper lobbying against Kim emerged after it came to light that Genescel had obtained a patent ruling and clinical trial approval based on a fabricated experimental report.
Prosecutors gave Kim a deferred indictment in December 2024, citing the absence of direct monetary exchange and the difficulty of establishing the illegality of the request. Controversy flared again after a photo surfaced showing Kim, broker Yang and a judge surnamed Jeong — who handled warrant reviews — together, reportedly taken around February 2022.
Kim's camp maintains that he "simply passed along a public-interest complaint, not an improper request."
forest@heraldcorp.com
