A clash broke out in the National Assembly over the approval process for the investigational new drug (IND) application for Genencell's COVID-19 treatment, which is entangled in allegations that a request was relayed by Justice Minister nominee Kim Seung-won. The People Power Party pressed to determine whether there was favoritism by pointing to the time it took to approve and the numerous requests for supplementation. The Ministery of Food and Drug Safety denied the favoritism allegations, saying that the expedited review system was applied to COVID-19 treatments at the time and that Genencell went through the same standards and procedures.
The Health and Welfare Committee held a plenary session on the 11th. Although substitute debates on bills and petitions under its jurisdiction were originally scheduled, a significant portion of the meeting was devoted to related questions after People Power Party lawmakers focused on raising allegations that Kim sought approval for Genencell's IND.
At the core of the allegations is the 2021 IND approval process for Genencell's COVID-19 treatment candidate "ES16001." Kim was said to have inquired with then head of the Ministery of Food and Drug Safety Kim Kang-lip about the status of Genencell's clinical trials at the request of a broker, and after that Genencell received approval from the ministry, prompting suspicions that an external request may have influenced the review.
The People Power Party particularly took issue with the speed of the approval. People Power Party lawmaker Han Ji-a claimed that while the average IND approval period for new-molecule COVID-19 treatments at the time was 71 days, Genencell received approval in 33 days. She also noted that it took 14 days from Kim's inquiry to the approval.
The supplementation process also became a point of contention. During the review, Genencell received requests to supplement 14 items, but it obtained approval eight days after submitting the supplemental materials. People Power Party lawmaker Lee So-hee pointed out that the 14 items included more than 30 detailed requests for supplementation and asked whether matters such as safety monitoring and efficacy and safety assessments were properly reviewed.
People Power Party lawmaker Choi Bo-yoon stressed that IND approval is an important gateway through which a candidate proceeds to a full-fledged new drug development phase. Choi argued that because the approval result can affect corporate value and fundraising, reviews must be conducted independently of outside influence, including from the political sphere, and called for further verification of the approval process at the time.
Questions were also raised over Genencell's nonclinical data. People Power Party lawmaker Cho Bae-sook alleged that the fact that hamsters died in Genencell's animal experiments was not properly submitted and argued that the circumstances under which IND approval was granted with such data on file should be scrutinized.
Oh Yu-Kyoung, the Minister of the Ministery of Food and Drug Safety, dismissed the favoritism allegations. She said that considering the expedited review program applied to COVID-19 treatments at the time, it is hard to see Genencell's review period as particularly short.
The Minister said, "At the time, the goal for COVID-19 treatments was to keep the review period within 15 days," and added, "For 45 COVID-19 treatment cases then, the average number of days the Ministery of Food and Drug Safety actually used for review was 10, and the Genencell case was 11."
She also pushed back against the criticism that approval came quickly despite numerous requests for supplementation regarding Genencell. The Minister said, "The supplemental items concerned amendments to the IND protocol and did not require additional experiments," and explained, "The number, difficulty, and time required for supplemental items do not necessarily increase in direct proportion."
She acknowledged as true the point that more than 30 detailed matters were included in the 14 supplemental requests. However, she explained that, administratively, a large classification number is tallied as a single item, so it is difficult to judge review difficulty based solely on the number of detailed requests.
The Minister said, "Even when something is listed as six items, if you break it down, there are cases where it exceeds 40," adding, "For administrative convenience, using a large classification number as an item is the same for any company."
Regarding the animal experiment data, the Ministery of Food and Drug Safety reviewed based on the materials submitted at the time, and she drew a line by saying that responsibility for any omission in the data itself lies with the company.
The Minister explained that if adverse reactions appeared in hamsters infected with COVID-19, it is standard to request additional data to determine whether the animals died from the disease or from the drug. She added that if it is true that parts of the data were deleted, that would be an issue on Genencell's side, and that it was not a matter the ministry's staff could have known up to the act of deleting that data.
Another point of contention was that evaluations of Genencell differed between the IND approval and the Ministry of Health and Welfare's research and development (R&D) support process.
Lawmaker Han Ji-a noted that Genencell applied five times for the ministry's R&D support project related to COVID-19 treatments but failed each time, and that it was evaluated then as having insufficient evidence of efficacy in nonclinical testing, whereas the Ministery of Food and Drug Safety approved a phase 2/3 IND.
Minister Jung Eun-kyeong of the Ministry of Health and Welfare countered that it is difficult to compare the two reviews directly. She said that the ministry's R&D support is a process of selecting recipients by weighing factors such as likelihood of development success, product differentiation, and commercialization potential within a limited budget, whereas the Ministery of Food and Drug Safety's IND approval is a process of determining, under regulatory standards, whether a clinical trial may proceed.
The Minister said, "An assessment that nonclinical efficacy evidence is insufficient or weak does not mean there is no efficacy at all," adding, "Sixty-nine cases applied for R&D support at the time, but only eight were selected, so it is hard to see a problem with the Ministery of Food and Drug Safety's approval solely because the project did not receive support from the ministry."
The Ministery of Food and Drug Safety also emphasized that it had already been investigated by prosecutors in connection with this case and that no facts were confirmed showing favoritism.
The Minister said, "Prosecutors conducted six raids on the Ministery of Food and Drug Safety, including the minister's office," and added, "Several ministry employees were investigated for a long time, and the case ended in a no-charge disposition."
The ruling and opposition parties also clashed over whether the day's meeting was the right venue to address the Genencell allegations.
Lawmakers of the Democratic Party of Korea protested, saying, "This is not the confirmation hearing room for nominee Kim Seung-won." Democratic Party lawmaker Seo Young-seok argued that if current-issue questioning is needed, a separate schedule should be set after consultation between the parties' secretaries.
At the end of the meeting, Health and Welfare Committee Chair Lee Man-hee acknowledged that prior consultations between the secretaries had been insufficient but still raised questions about the Genencell case. He pointed out that approval of the clinical trial at the time appears to have been used by stock-price-manipulation forces and said it is necessary to verify the facts in the related materials.