(Seoul = Yonhap News) Reporter Shin Seon-mi = Hyundai Pharmaceuticals [004310] announced that it will submit supplementary data on its risk management plan within next month for domestic approval of 'Mifgene', widely known as a pregnancy abortion drug.
In response to a related question at the National Assembly Health and Welfare Committee's comprehensive audit held on the 27th, Lee Sang-jun, CEO of Hyundai Pharmaceuticals, said, "We are preparing with the intention of unconditionally submitting it within next month at the latest."
Previously, the government announced its policy to introduce abortion drugs, and the Ministry of Food and Drug Safety decided to promote related procedures with the goal of introduction within the first quarter of next year.
Hyundai Pharmaceuticals has been preparing to introduce ‘Mifzimiso’, an oral abortion drug from Line Pharma International of the UK. MIFZIN is a single ingredient, while MIPZ Miso is a complex ingredient.
Social safety issues are constantly being raised regarding the introduction of abortion drugs.
Regarding these concerns, Representative Lee said, “I understand that there are concerns about the drug itself, as well as problems with distribution and misuse.”
He added, “We are discussing risk management measures with the Ministry of Food and Drug Safety after the drug is launched,” adding, “The Ministry of Food and Drug Safety is very conservative and talks a lot about how to manage it safely.”
Kim Jae-yeon, president of the Korean Association of Obstetricians and Gynecologists, also expressed concern about the safety of Mifjin.
Chairman Kim said, “Despite the results from the FDA (U.S. Food and Drug Administration) coming out in March next year, the Ministry of Food and Drug Safety says it will proceed with (introduction) early,” and added, “Looking at the past actions of the Minister of Food and Drug Safety, who was very concerned about the safety of Mifgene, we cannot help but be concerned.”
He criticized the FDA's push to introduce drugs before re-verification, saying, "To put it a little harshly, I think it's like 'testing on the public'. To put it even more severely, 'I think it's like conducting a kind of Maruta experiment on women who are very vulnerable and sensitive to childbirth.'"
When asked whether there was any discussion about emergency treatment after taking Mifjin, Chairman Kim responded, "There is no control tower in the relevant organizations," and "There was no discussion with the parties involved, so I would like to ask in what form it took place."
On this day, the positions of the ruling and opposition parties were mixed on whether to implement the MIF Jin bridge test. A bridging test is a test that looks at differences in the safety and effectiveness of a drug by race or country.
Lee Man-hee, Chairman of the Health and Welfare Committee (People Power Party), said, "The FDA is reviewing the safety of the use of Mifjin, and as a result of a bridging clinical trial in Japan, adverse cases such as lower abdomen pain and vomiting occurred in nearly 57% of cases. There is a need to conduct a bridging clinical trial in Korea as well."
However, Nam In-soon, a member of the Democratic Party of Korea, said, "When Hyundai Pharmaceuticals first applied for product approval in July 2021, there was discussion about a bridge clinical trial, but in September of that year, the Central Pharmaceutical Review Committee decided not to conduct it."
In response to this, Minister of Health and Welfare Jeong Eun-kyung said, "The Ministry of Food and Drug Safety is reviewing the approval. As women's safety is the most important, we will prepare to establish a safe use system in consultation with the medical community."
Regarding the revision of related laws, Minister Jeong responded, "The Ministry of Justice is preparing the Criminal Act, and several lawmakers have submitted amendments to the Maternal and Child Health Act. We will actively cooperate when the government prepares an alternative and deliberates the bill."
Hyundai Pharmaceuticals said it would be difficult to predict sales once Mifgene is approved.
Representative Lee said, "I couldn't find accurate statistics on how many abortions were occurring. A research report published about four years ago said there were about 30,000 abortions, but there was no information on how many abortions occurred within a few weeks."
