Clash Over Clinical Trial Approval: Calls for MFDS Apology vs. Denials of Special Favor

[Anchor]

The alleged lobbying involving Justice Minister nominee Kim Seung-won and the Ministry of Food and Drug Safety emerged as a hot topic at a National Assembly Health and Welfare Committee meeting. While the People Power Party criticized that a single phone call from a prominent politician led to the approval of inadequate documents, the head of the ministry clarified that there were absolutely no special favors.

Here is more from reporter Park Jae-yeon.

[Reporter]

At yesterday's plenary session of the National Assembly Health and Welfare Committee.

Although bill reviews were scheduled, the controversy surrounding Justice Minister nominee Kim Seung-won and the alleged lobbying of the Ministry of Food and Drug Safety took center stage.

[Choi Bo-yoon / People Power Party Lawmaker]: Is the Ministry of Food and Drug Safety a power-tailored regulatory agency that gives a "free pass" based on inadequate documents with just a single phone call from a powerful politician?...

[Seo Young-seok / Democratic Party Lawmaker]: Wasn't it cleared of charges after being thoroughly scrutinized for two years under the previous administration?

Attention also focused on questions regarding SBS's exclusive report the day before, which revealed that after new drug developer Genencell obtained clinical trial plan approval from the Ministry of Food and Drug Safety in October 2021, it sought to receive over 32 billion won in government subsidies starting that December, but the Ministry of Health and Welfare rejected the support five times, citing insufficient evidence of efficacy or low potential for new drug development.

[Han Ji-a / People Power Party Lawmaker]: The conclusions of the Ministry of Health and Welfare and the Ministry of Food and Drug Safety differ. The difference lies in whether nominee Kim Seung-won made a request or not, regarding the effectiveness of the same non-clinical and animal studies.

[Jeong Eun-kyeong / Minister of Health and Welfare]: The evaluations for the Ministry of Food and Drug Safety's clinical trial plan approval and the Ministry of Health and Welfare's R&D research funding support have different purposes and evaluation criteria in the first place...

MFDS Minister Oh Yu-kyung, who took office seven months after the approval, drew a line by stating that there were no special favors whatsoever during the approval process at the time, and attributing the acquisition of approval through fraudulent reports to Genencell.

[Oh Yu-kyung / Minister of Food and Drug Safety]: It is the fault of Kang Se-chan, the founder of Genencell, and his fraudulent means, and it was not a matter that Ministry of Food and Drug Safety officials could have evaluated...

A shareholder of Sejong Medical, a Kosdaq-listed company that invested in Genencell, held a press conference at the National Assembly yesterday, urging that the truth behind the suspected stock manipulation and nominee Kim's role in the MFDS approval process be clearly revealed.

(Photo courtesy of Yonhap News)
(Video reporting: Oh Young-chun, Kim Yong-woo | Video editing: Won Hyung-hee)
※ Please note: This article was translated by AI and may contain errors.