'Distrust in MFDS rises after Leqembi safety issue'

due to inadequate MFDS approval and post-market surveillance

Rep. Jin-sook Jeon criticizes the lack of post-market safety measures during the NA audit

The Ministry of Food and Drug Safety (MFDS) has been criticized for losing public trust due to inadequate safety verification of the dementia drug Leqembi (Lecanemab) and poor post-marketing adverse event management measures.

 

On the 18th, during the National Assembly audit of the MFDS, Representative Jin-sook Jeon of the Democratic Party of Korea criticized, “The MFDS has caused a crisis of trust at every stage of the approval and post-marketing management of dementia drugs.

 

It must take responsibility and apologize before the public’s life.” Although Minister Yu-Kyoung Oh explained during last year's audit that ‘Aduhelm was not being used in Korea,’ the Korea Orphan Drug Center confirmed that a total of 5,847 vials were supplied for self-treatment at patients' request from 2021 to 2024.

 

Jeon said this could constitute false reporting or perjury before the National Assembly.

 

Rep.

 

Jeon criticized, “Similarly, 448 vials of Leqembi were supplied for self-treatment before its official domestic launch.

 

Despite knowing this, the MFDS answered ‘it was not in use..

 

MFDS’s safety management system failed to function during the pre-approval phase for Leqembi.” He further stated that the MFDS, which promised thorough post-marketing surveillance, is relying solely on reports from the pharmaceutical company.

 

Jeon explained that surveillance is being conducted based on how much of the ‘post-marketing surveillance’ management plan submitted by the pharmaceutical company during the approval process has been quantitatively achieved.

 

This is criticized as a dereliction of duty, entrusting patient safety to the pharmaceutical company.

 

Rep.

 

Jeon stated, “The U.S.

 

FDA identified 6 deaths (4 unique cases after deduplicating) during the initial administration phase in its 2024 routine drug surveillance process and took safety measures, increasing MRI follow-up scans from three to four times.

 

However, no separate follow-up measures have been made by our MFDS to date.” Domestically, 135 adverse events were reported within a year of its approval, with 12 (9%) classified as serious adverse events.

 

Major adverse events included ▲ cerebral edema ▲ microbleeds ▲ hemosiderin deposition, identified as ‘amyloid-related imaging abnormalities (ARIA)’, posing risks of long-term brain damage and atrophy.

 

Rep.

 

Jeon stated, “The Yoon Suk-yeol administration appointed Director Yu-Kyoung Oh under the pretense of ensuring science and trust.

 

However, the MFDS's science has vanished, and its trust collapsed.

 

Minister Oh must apologize to the public for undermining the public’s trust.” She further proposed alternatives, stating, “New mechanism drugs, high-risk biological products, and conditionally approved drugs must be legislated to mandate external expert consultations..

 

The lack of post-marketing surveillance obligations for self-administered drugs requested by patients must be addressed to strengthen safety monitoring.

 

Guidelines for regular inspections of adverse effects from self-administered drugs must also be established.”