[2020 National Audit] Today’s MFDS Audit... Public Masks and White Particle Vaccines Expected to Be Key Issues

On the 8th, the National Assembly Health and Welfare Committee conducted a government audit of the Ministry of Health and Welfare and others via video conference. Photo by Yoon Dong-ju doso7@

[Asia Economy Reporter Cho Hyun-ui] The National Assembly’s Health and Welfare Committee will conduct a government audit of the Ministry of Food and Drug Safety and the National Institute of Food and Drug Safety Evaluation on the 13th.

The audit, starting at 10 a.m., will have witnesses including Chosunhye, CEO of GeoYoung. Sharp questions between the ruling and opposition parties are expected regarding the public mask system, which was controversial during the early stages of the novel coronavirus infection (COVID-19) crisis when the "mask crisis" occurred.

In particular, the opposition party is expected to focus heavy criticism on GeoYoung, which has been embroiled in allegations of preferential treatment. The opposition has long claimed that "the process by which GeoYoung was selected as a mask supply and sales outlet and the nomination application process are suspicious."

Earlier in April, the opposition alleged that the government effectively monopolized the distribution of public masks through GeoYoung, allowing it to earn at least 3 billion KRW in excessive profits. There was also criticism that GeoYoung supplied bulk public masks for pharmacies and then delegated repackaging tasks to pharmacists to save on labor costs.

The government and GeoYoung responded by explaining, "Due to the surge in mask volume, overnight delivery fees and overtime labor costs were a significant burden, so it is not excessive profit."

Quality and management system inspections are also expected for the influenza (flu) vaccine, which has been controversial due to issues such as "exposure to room temperature" and "white particle detection." The opposition plans to argue that since the Ministry of Food and Drug Safety decided on the 9th to voluntarily recall and dispose of the Cobaxflu 4-valent PF vaccine due to safety concerns over white particles, the same standards should apply to products with the same manufacturing date whose white particles have not been identified.

Previously, white particles, suspected to be antigen protein aggregates, were found in some batches of Cobaxflu 4-valent PF vaccine produced by Korea Vaccine Co., Ltd. The Ministry of Food and Drug Safety conducted additional tests and confirmed that among six manufacturing lots of the product, four lots filled in syringes by a specific company had a higher number of fine particles. Consequently, on the 9th, the manufacturer was instructed to voluntarily recall a total of 615,000 units of the product.

The issue of raw material defects in botulinum toxin preparations, commonly known as "Botox," is expected to be raised during the comprehensive audit on the 22nd. Originally, Jung Hyun-ho, CEO of Meditox, was scheduled to attend the audit, but Executive Director Joo Hee-seok will attend on the 22nd instead.

Meditoxin was the first domestically produced botulinum toxin injection product to receive approval from the Ministry of Food and Drug Safety in 2006. However, in June, the Ministry finalized the cancellation of approval for three Meditoxin products due to violations of the Pharmaceutical Affairs Act, including the use of unauthorized raw materials and falsification of documents.

Seo Jung-jin, chairman of the Celltrion Group, who was also selected as a witness for the audit, will not attend. Baek Jong-heon, a member of the People Power Party, initially requested Seo’s attendance to inquire about the development status of COVID-19 therapeutics. However, since many questions regarding therapeutic development have been sufficiently addressed and considering the on-tact (online) audit format, the request was withdrawn.

This content was produced with the assistance of AI translation services.