The regulator in the hot seat to decide on the prescription of an abortion drug


The Ministry of Food and Pharmaceutical Safety (MFDS) will hold a consultative meeting with external experts on Wednesday to determine whether a Mifegymiso abortion pill should become a prescription drug and who should be allowed to prescribe it.

Moon Eun-hee, director of the drug policy division at MFDS, met with reporters earlier Tuesday and released details of the ministry’s review on whether to grant marketing authorization for Mifegymiso .

The government will discuss with outside experts whether the Mifegymiso abortion pill should become a prescription drug and who should be allowed to prescribe it.

Moon has made it clear that the MFDS will authorize Mifegymiso as a prescription drug, as requested by Hyundai Pharm.

Previously, some civic groups had asked the regulator to approve the pill as an over-the-counter (OTC) drug that can be purchased from pharmacies without a prescription to improve consumers’ access to the drug.

However, Moon has ruled out the possibility of approving Mifegymiso as an over-the-counter drug.

Yet the government has yet to decide on the extent of authority in prescribing Mifegymiso.

The MFDS is considering whether to allow only specialists in obstetrics and gynecology to prescribe the drug or specify separate eligibility for prescribing abortion drugs.

“Countries that have authorized the drug have different methods of administration after dispensing. So we need a national consultation on this issue, ”Moon said. “This will be discussed at the consultative meeting. “

Obstetricians and gynecologists argue that Mifegymiso should become an exception to the local system of separating the dispensing of drugs from the prescription of drugs. Instead, the pill should be administered directly in a clinic or hospital.

The ministry has yet to decide whether or not to exempt a transition trial for Mifegymiso, a thorny issue affecting marketing authorization in Korea.

Moon said that although a majority of the Central Pharmaceutical Affairs Council was inclined to support the exemption from the bridging study, nothing was decided.

She also said that the MFDS may also gather public opinions to discuss the details of the introduction of Mifegymiso to Korea.

“The consultative meeting won’t decide all of a sudden. Instead, the government has collected the opinions of every related group, and if necessary, it will do it again, ”Moon said.

The MFDS has asked Hyundai Pharm to submit additional data for consideration of the approval of Mifegymiso.

The Korea Association of Obstetricians and Gynecologists, the Korean Medical Association, the Korean Pharmaceutical Association and the Korea Association of Hospital Pharmacies will join the consultative meeting on Wednesday.

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