South Korea's Ministry of Food and Drug Safety reaffirmed that it will not conduct separate bridging trials on Korean subjects before introducing mifepristone, the abortion pill widely known as Mifegyne. Addressing safety concerns raised abroad, the agency said those claims differ from the official assessment of the U.S. Food and Drug Administration, and stressed that abortion pills now circulating illegally should be brought under regulatory oversight so they can be managed safely and users can seek redress for harm.
Oh Yu-kyoung, commissioner of the Ministry of Food and Drug Safety, told a parliamentary audit by the National Assembly's Health and Welfare Committee on the 13th that "to date, no particular adverse reactions have been identified by race or by country, as far as I understand." The remarks maintain the position she set out at a full committee meeting last month, when she indicated the agency was not planning separate bridging trials as part of the drug's introduction.
Bridging trials are additional studies conducted when overseas clinical data are used to support domestic approval, to verify whether a drug's safety and efficacy differ by race or country.
The drug's safety also became a point of contention at the audit. Cho Bae-sook, a lawmaker of the People Power Party, cited a report by the U.S. Ethics and Public Policy Center that analyzed about 865,000 insurance claims related to mifepristone from 2017 to 2023, and said 10.93% of users experienced serious adverse events such as sepsis, infection or hemorrhage within 45 days of taking the drug. That rate is far higher than the under-0.5% incidence of side effects presented when the drug was first approved, she said.
Oh said she was aware of the report and its summary findings, but added that "there is some difference between the report's claims and the official position of the U.S. FDA." She also said that "looking at overseas clinical data and approval documents worldwide, no particular adverse reactions have been identified in connection with differences by race or country, as far as I understand."
The ministry argues that safety concerns are themselves a reason to bring abortion pills within a legal oversight framework. "Right now, young women in our country are obtaining this drug, which has severe side effects, through illegal channels, and that is a blind spot where they go unprotected," Oh said. "Given the safety concerns, I believe the right approach is one that allows these women to seek redress for harm through more lawful means."
The government announced its plan to introduce abortion pills last month, and the ministry is pursuing the necessary procedures with a target of introduction within the first quarter of next year.