NA-MFDS clash on the approval of abortion pills

NA requests expedited review of the drugs

Reimbursement of the drugs ‘paused’ due to the non-revision of the Criminal Act, Mother and Child Health Act ‘

MFDS Minister Yu-Kyoung Oh, “lacks requirements for granting approval”

Rep In-soon Nam, “Don’t blame the law... we request a solid answer until the NA audit.”

With the National Assembly strongly pressing the need for domestic marketing authorization of the abortion drug ‘Mifegymiso,’ the NA’s request is set to affect the future administration of the MFDS’s marketing authorization review.

 

The MFDS has repeatedly argued that the Criminal Act and the Mother and Child Health Act must be amended before the drug receives marketing authorization, but the National Assembly responded that this is an unacceptable excuse and that the drug’s listing should not be delayed any longer.

 

On the 10th, Democratic Party of Korea lawmaker In-soon Nam made inquires to Yu-Kyoung Oh, the head of the Minister of Food and Drug Safety, that the government should take steps to identify the illegal distribution, trade, misuse, and side effects of Mifegymiso by granting marketing authorization for the abortion drug.

 

In fact, 705 cases of illegal sales of abortion drugs such as Mifegymiso were found by July this year.

 

Rep Nam pointed to the fact that doctors, pharmacists, and civil society organizations have filed multiple requests for the designation of abortion drugs as essential medicine and their urgent introduction, and requested the MFDS to be proactive in grating their marketing authorization.

 

“The Board of Audit received an audit claim that the MFDS is neglecting its responsibility to introduce abortion drugs,” Nam said, adding, “I think the MFDS should respond quickly.” Rep.

 

Nam added, “There are WHO guidelines, and preparations (permits) that need to be made.

 

Please study cases overseas and review and submit these contents until the general audit.

 

You shouldn't just blame it on the law.

 

Women are being harmed.” Minister Oh said that she would submit the data that the MFDS had prepared for the marketing authorization, but replied that “MFDS is a licensing agency” and that “We lack the requirements to grant marketing authorization (for abortion pills).” So what does Minister Oh mean by ‘lack of requirements’?

 

Hyundai Pharm, which had been preparing to distribute the abortion drug Mifegymiso in Korea, applied for marketing authorization to MFDS several times.

 

Specifically, Hyundai applied for the marketing authorization of Mifegymiso in July 2021, and then voluntarily withdrew the application in December 2022.

 

In March 2023, the company reapplied for Mifegymiso, and the MFDS currently has the application and supporting data.

 

The MFDS has repeatedly explained that the Criminal Act and the Mother and Child Health Act must be amended before granting marketing authorization for the drug.

 

The amendments to the Criminal Act and the Mother and Child Health Act need to be made to clarify the period of abortion permitted by law so that the risk management plan required for the approval and review of abortion drugs can be confirmed.

 

In other words, the MFDS’s position is that the relevant laws must be amended first, and then the pharmaceutical company must submit the risk management plan approval data for the Ministry to resume the review and decide whether to approve the drug for marketing authorization.

 

However, members of the National Assembly's Ministry of Health and Welfare, including Rep Nam, have been pointing out that the MFDS’s position is difficult to accept.

 

The criticism is that the agency is using the risk management plan as an excuse to avoid getting involved in the controversy over the approval of the abortion pill.

 

“It is difficult to understand the MFDS’s explanation that it cannot approve abortion pills because the National Assembly has not passed subsequent legislations related to abortion, such as the Criminal Act and the Mother and Child Health Act,” said an official from the National Assembly's Welfare Committee.

 

“Drugs should be approved based on safety and efficacy based on scientific and medical review data.

 

Whether the abortion period is set at 16 weeks or 36 weeks should not affect MFDS’s safety and efficacy review.”