A plan to designate glucagon-like peptide-1 (GLP-1) obesity drugs as medicines at risk of misuse is being delayed in South Korea, even as prescriptions for the treatments surge.
Of the 15 items taken up at the Regulatory Rationalization Committee's preliminary screening on Sept. 21, only the proposed amendment to rules on designating medicines at risk of misuse failed to complete screening and was referred to full review, according to the government's regulatory information portal on the 17th.
Preliminary screening is the procedure that filters out significant regulations among newly created or tightened government rules that require further examination by the committee. Because the screening was not completed, the plan to designate obesity drugs as medicines at risk of misuse has been classified as a significant regulation and will go before the committee for deliberation.
On the 11th, Park Yong-jin, vice chairman of the Regulatory Rationalization Committee, signaled a cautious stance on the designation in a post titled "Why Should Viagra and Mounjaro Face the Same Regulation?"
"Indiscriminate prescribing and illegal distribution must of course be controlled, but we need to examine whether attaching a 'misuse' label first, simply because there are concerns about misuse, is the best policy," Park said, warning that the rules risk leaving behind nothing but fear and stigma.
The Korean Diabetes Association had earlier voiced similar concerns. "Simply assigning the name 'medicine at risk of misuse' without putting in place substantive management and oversight procedures or enforcement measures is an administratively expedient approach," the association said, calling for effective guidelines to block illegal distribution and excessive prescribing.
Once a drug is designated as a medicine at risk of misuse, the label must be printed on the container or packaging. Buyers would also need a doctor's prescription to purchase the drug even in areas exempt from the separation of prescribing and dispensing.
The Ministry of Food and Drug Safety announced in June that it would designate obesity drugs as medicines at risk of misuse. At a parliamentary audit on the 13th, responding to concerns that prescriptions for obesity drugs are rising sharply and that some are being prescribed to pregnant women and children, the ministry said it would continue to pursue the designation.
Distribution of GLP-1 obesity drugs in South Korea is indeed climbing fast. Volume stood at 160,000 units in October 2024 but reached about 3.12 million units in July this year, a twentyfold increase.
"We will provide further explanation on the need for the designation during the review process," said Oh Yu-kyoung, commissioner of the Ministry of Food and Drug Safety.