The National Assembly's Health and Welfare Committee resumed its audit of the Food and Drug Administration (FDA) after an initial disruption caused by protests from both ruling and opposition parties. The session focused on critical food and drug safety issues directly affecting public health.
Key topics included the FDA's delayed response to severe side effects associated with the weight loss drug Wegovy, the ongoing legislative gap regarding the abortion pill Mifepristone, and the effectiveness of the braille labeling system for medications.
On October 13, the committee continued its audit with testimonies from FDA officials, including Commissioner Oh Yu-kyung. Lawmakers criticized the FDA for failing to proactively monitor and provide guidelines for new high-risk medications.
Lawmakers Criticize FDA for Delayed Response to Weight Loss Drug Side Effects
During the audit, the FDA's inadequate monitoring of Wegovy's severe side effects, specifically non-arteritic anterior ischemic optic neuropathy (NAION), was a focal point. Representative Baek Sun-hee of the Justice Party questioned the FDA's passive post-market surveillance. She stated, "Despite a surge in prescriptions for Wegovy and other weight loss drugs, patient safety monitoring has been poorly executed. A suspected case of vision impairment was reported in December 2024, a month earlier than in the U.S., yet the FDA failed to conduct follow-up investigations in line with international guidelines."
Baek further emphasized, "Even a single case is a significant warning sign. Did you properly assess the patient's condition? This is typical bureaucratic delay, only acting after foreign regulatory agencies take action." In response, Commissioner Oh stated, "We are currently in the process of changing the approval status following the report of adverse events and will strive to provide safety information promptly, even before the changes are finalized."
Illegal Distribution of Mifepristone Raises Concerns Over Legislative Gaps
The issue of illegal distribution of Mifepristone, an abortion pill, was also addressed, highlighting a seven-year legislative gap since the Constitutional Court's ruling on the unconstitutionality of the abortion law in 2019. Representative Jo Bae-sook of the People Power Party criticized the push for its introduction without legal grounds. She stated, "There are serious risks of incomplete miscarriages and other severe side effects in the absence of legislative measures. Introducing Mifepristone through administrative orders without fundamental amendments to the Criminal Code and Maternal Health Act infringes on legislative authority." Jo also stressed the need for safety management and measures to prevent illegal distribution, particularly for Korean women, who may differ in body type from foreign populations.
Commissioner Oh responded, "We are continuously strengthening monitoring of illegal distribution to protect women's health. When pharmaceutical companies submit applications for product approval, we will thoroughly review expert consultations and risk management plans to ensure safety."
Only 0.1% of Medications Required to Have Braille Labels, Lawmaker Says
The audit also revealed shortcomings in the mandatory braille labeling system for medications, aimed at improving accessibility for visually impaired individuals. Representative Seo Mi-hwa of the Democratic Party brought attention to the issue by presenting medication packaging at the hearing. She noted, "While there are over 35,000 medications approved or reported in Korea, only 39 are required to have braille labels, which is about 0.1% of the total. We need to expand the scope of braille labeling significantly."
Seo pointed out the confusion in the current system, stating, "QR codes can be easily scanned with a smartphone camera, but barcodes require separate access to the Drug Safety Information Center, making it very inconvenient for visually impaired individuals. Even when braille is present, the low height makes it difficult to read with fingertips." She called for the establishment of standard specifications focused on readability.
Commissioner Oh acknowledged these concerns, stating, "We have heard suggestions about standardizing QR codes and designating their locations. We will research ways to unify code placement and promote best practices for braille labeling. Additionally, we will utilize research budgets to urgently revise related standards."
* This article has been translated by AI.
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