The Ministry of Food and Drug Safety (MFDS) will hold an advisory meeting with external experts on Wednesday to discuss whether an abortion pill Mifegymiso should become a prescription drug and who should be allowed to prescribe it.
Moon Eun-hee, director of the Pharmaceutical Policy Division at the MFDS, met with reporters earlier on Tuesday and released the details of the ministry’s review on whether to grant marketing approval for Mifegymiso.
Moon made it clear that the MFDS would authorize Mifegymiso as a prescription drug, as requested by Hyundai Pharm.
Earlier, some civic groups demanded the regulator approve the pill as an over-the-counter (OTC) medicine that can be purchased at pharmacies without prescription to improve consumers’ access to the drug.
However, Moon ruled out the possibility of approving Mifegymiso as an OTC drug.
Still, the government has yet to decide the scope of authority in prescribing Mifegymiso.
The MFDS is reviewing whether to allow only obstetrics and gynecology specialists to prescribe the drug or specify separate eligibility for the abortion drug prescription.
“Countries that authorized the drug have different administration methods after dispensing. So, we need domestic consultation on this matter,” Moon said. “This will be discussed at the advisory meeting.”
Ob-gyn doctors argue that Mifegymiso should become an exception from the local system separating drug dispensing from drug prescribing. Instead, the pill should be directly administered within a clinic or a hospital.
The ministry has also yet to decide whether to exempt a bridging trial for Mifegymiso, a thorny issue affecting marketing approval in Korea.
Moon said although a majority of the Central Pharmaceutical Affairs Council were inclined to support the exemption of the bridging study, nothing has been decided.
She also said the MFDS could additionally collect public opinions to discuss the details of the introduction of Mifegymiso in Korea.
“The advisory meeting will not decide everything at once. Instead, the government collected opinions from each related group, and if necessary, it will do so again,” Moon said.
The MFDS has requested Hyundai Pharm to submit additional data for the review of Mifegymiso approval.
On Wednesday, the advisory meeting will be joined by the Korean Association of Obstetricians & Gynecologists, the Korean Medical Association, the Korean Pharmaceutical Association, and the Korea Hospital Pharmacy Association.