The National Assembly's Health and Welfare Committee hearing on the Food and Drug Safety Agency (FDA) was marred by intense conflict over allegations of lobbying related to Genensel. The People Power Party (PPP) protested the exclusion of key witnesses, claiming that a sitting lawmaker had intervened in the clinical approval process for Genensel's COVID-19 treatment. The Democratic Party (DP) countered that this was an inappropriate political attack on an ongoing legal matter, leading to a tense atmosphere that temporarily halted the meeting.
On October 13, the Health and Welfare Committee conducted its 2026 national audit, targeting 14 agencies, including the FDA. However, before the agency's witnesses, including Director Oh Yu-kyung, could begin their reports, the hearing room erupted in chaos as PPP lawmakers staged a protest over the failure to select witnesses related to Genensel.
The core issue of the hearing was the 'Genensel pressure allegations,' which claim that internal FDA reports were manipulated during the approval process for Genensel's COVID-19 treatment in 2021, allegedly involving requests from a current lawmaker.
Immediately after the meeting commenced, PPP lawmakers displayed signs reading 'Concealment of witness refusal materials.' PPP lawmaker Baek Jong-hun stated, 'Not a single key witness, including former Genensel CEO Kang Se-chan, was called due to opposition from the DP. How can we call this a genuine national audit when those who can address public concerns are absent?'
Lawmaker Jo Bae-sook added, 'Refusing to call former CEO Kang under the pretext of an ongoing trial is a dereliction of duty by the National Assembly. We are not trying to interfere in the trial; we want to clarify whether a sitting lawmaker abused their power to pressure the FDA.'
Lawmakers Han Ji-a and Lee Dal-hee criticized the FDA's handling of document requests, stating, 'Despite our demands for the internal report regarding the allegations against lawmaker Kim Seung-won, the FDA repeatedly claimed there were no documents or allowed only limited access without external experts. Are they trying to conceal matters that directly affect public health under the guise of protecting a corporation?'
Committee Chair Lee Man-hee also directed criticism at the FDA, saying, 'The 17-page initial report from Jeonbuk National University's Industry-Academic Cooperation Foundation indicated severe side effects, including hamsters bleeding and dying, but it was manipulated at Genensel's request and submitted to the FDA as a six-page document. I urge you to submit all related materials to clarify how clinical approval was granted based on this manipulated data.'
In contrast, the DP labeled the PPP's actions as 'excessive political attacks.' DP lawmaker Seo Young-seok stated, 'It is inappropriate to unilaterally display signs and turn the committee into a platform for political attacks without agreement between the party whips.' Lawmaker Kim Kyo-heung criticized the PPP for dragging an old issue related to a fellow lawmaker into the national audit, calling it a publicity stunt aimed at live broadcasts.
Lawmaker Nam In-soon defended the FDA's regulatory expertise, asserting, 'The FDA does not grant approvals based on political judgments or individual requests. An investigation during the previous administration concluded there was no evidence of improper approvals, yet some are irresponsibly undermining the credibility of the entire drug review system in South Korea by labeling it as 'poison gate' or 'successful lobbying.'
Nam also addressed the '17-page manipulated report,' stating, 'While it is true that Genensel submitted a manipulated six-page report, the FDA never received the original 17-page document, so the allegations of concealment are unfounded.'
Lawmaker Lee Soo-jin pointed out the breach of agreement and lack of respect for fellow lawmakers, saying, 'I also wanted to call Seoul Mayor Oh Se-hoon as a witness, but I respected the PPP's opposition. It is inappropriate to reverse agreements and stage protests now, especially by mentioning the name of a fellow lawmaker (Kim Seung-won) who is not present.'
Amid the fierce exchanges between the parties, Director Oh Yu-kyung appeared visibly taken aback but firmly denied any intent to conceal information. Regarding the internal report on the COVID-19 treatment raised by lawmaker Han Ji-a, she stated, 'That document has not been confirmed yet,' but added, 'I will review it thoroughly once again.'
However, she actively defended against accusations of withholding information, asserting, 'We provided extensive materials for nearly four hours and explained them as thoroughly as possible. The issue at hand is that the company (Genensel) submitted false reports during the trial process, but there was no intent on the FDA's part to conceal or hide anything.'
Ultimately, the national audit was unable to proceed with witness selection and continued to be disrupted by protests, failing to even begin the work reports before adjourning for the morning.
* This article has been translated by AI.
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