Korea FDA repeals decision to reclassify EC as OTC

The Korea Food and Drug Administration (KFDA) as well as the Ministry of Health and Welfare decided on Wednesday, August 29 to repeal an earlier initiative that would have approved emergency contraception (EC) for over-the-counter use. This May, health authorities declared that, beginning next year, EC would be reclassified as an over-the-counter drug while combined oral contraceptives (OCs), which are currently available OTC, would require a prescription. But as a result of charged debate between religious communities, women’s groups, medical experts and the general public over the issue, the KFDA has temporarily abandoned the reclassification initiative. EC will still require a prescription and combined OCs will remain OTC. Administrators decided to postpone reclassifying contraceptives for three years in order to carefully examine side effects of EC as well as to survey public opinion. EC is currently available without a prescription, either over the counter or behind the counter, in more than 60 countries. For information about the safety of EC, please see the fact sheet on the safety of levonorgestrel-alone emergency contraceptive pills (LNG ECPs) published by WHO, ICEC, FIGO and IPPF.