EXCLUSIVE: "Pledges Required, Data Verified, and Fines Imposed": Inside MFDS's Proposed Overhaul

Genencell, a drug development company, has been implicated in influence-peddling allegations involving the Ministry of Food and Drug Safety (MFDS) and Democratic Party lawmaker Kim Seung-won, a former nominee for justice minister.

In September 2021, an animal testing report by researchers at Jeonbuk National University submitted by Genencell to the MFDS had significantly omitted safety evaluation sections, including photographs of bleeding in hamsters, and controversy arose after it was revealed that the MFDS approved clinical trial plans based on this report.

During the parliamentary audit of the MFDS on October 13, this issue was heavily discussed, and MFDS Minister Oh Yu-kyoung promised to devise improvement measures.

SBS obtained and reviewed the MFDS improvement plan through the office of National Assembly Health and Welfare Committee Chairman Lee Man-hee. Under measures to strengthen pre-verification of review data, the MFDS stated, "In the case of efficacy testing, we will require the submission of essential summary information, such as the animal species and the number of subjects used in the tests."

It also stated, "If original data verification is deemed necessary during the review process, we will request and verify the original non-clinical test data."

In addition, the plan includes a principle requiring "the submission of a signed pledge from both the sponsor and the head of the testing institution certifying that the submitted materials contain no falsehoods."

To enhance the oversight of testing institutions, the agency is strengthening the effectiveness of unannounced on-site inspections and expert advisory meetings. It is also considering imposing punitive fines, restricting clinical trial applications, and publicly disclosing the names of companies if the submission of false data is confirmed.

However, while the MFDS's self-devised improvement plan received positive assessments, questions regarding its effectiveness were also raised.

People Power Party lawmaker Lee Man-hee, chairman of the National Assembly's Health and Welfare Committee, stated, "It remains crucial what the MFDS verifies and the extent to which it holds parties accountable. We must ensure not only the truthfulness of submitted materials, but also completeness—to verify that key tests and results were not omitted—as well as traceability to distinguish original reports from sponsor-processed data."

He further emphasized, "Even if the system is established along the proposed improvement direction, its effectiveness will inevitably fall short if it fails to properly close the loopholes of data omission and reprocessing exposed in the Genencell case."

The MFDS plans to gather feedback based on the improvement measures reported to the National Assembly, conduct policy research in the near future, and finalize the improvement plan around April to May next year.

(Reported by Son Hyeong-an | Video by Kim Seung-tae | Video Editing by Lee Yu-jin | Design by Lee Jeong-ju | Materials provided by the office of People Power Party Lawmaker Lee Man-hee | Produced by SBS Digital News)
※ Please note: This article was translated by AI and may contain errors.