(Seoul = Yonhap News) Reporter Park Sang-hyun = The designation of glucagon-like peptide-1 (GLP-1) class obesity treatment drugs, which have rapidly increased in prescriptions in Korea, as drugs of concern for misuse is being delayed.
The Ministry of Food and Drug Safety announced last June that it would designate obesity treatment drugs as drugs at risk of abuse, and has since expressed its intention to pursue the plan, but it appears that the brakes have been put on hold.
According to the Regulatory Information Portal on the 17th, in the preliminary review by the Regulatory Rationalization Committee on the 21st of last month, among the 15 items on the agenda, only the revision to the regulations on designation of drugs with a risk of abuse was not completed and was submitted to the main review.
The preliminary review is a process to filter out important regulations that require additional review at the committee level among newly established and strengthened government regulations, and the plan to designate obesity treatment drugs as drugs with concerns about misuse was classified as an important regulation and was subject to committee deliberation.
In relation to this, Park Yong-jin, Vice Chairman of the Regulatory Rationalization Committee, wrote on the 11th, 'Why do Viagra and Maunjaro have to be subject to the same regulations?', expressing a cautious stance on designating obesity treatment drugs as drugs of concern for abuse.
Vice Chairman Park said, “Indiscriminate prescriptions and illegal distribution must be managed, of course, but it is necessary to consider whether labeling it as ‘abuse’ first because there is a risk of abuse is the best policy,” and pointed out that too much regulation can only leave fear and stigma.
Previously, the Korean Diabetes Association also acknowledged the misuse and abuse of obesity treatment drugs in a statement released in late June of this year, but said that designating drugs with concerns about abuse is a separate issue.
The society said, “It is an administratively expedient approach to simply give the name ‘drugs of concern for abuse’ without establishing actual management/supervision procedures or crackdown measures,” and urged the establishment of effective guidelines to block illegal distribution and excessive prescriptions.
In this situation, there is a view that the fact that Hanmi Pharmaceutical [128940] 'Epee', the first domestically produced GLP-1 type obesity treatment, has been approved by the Ministry of Food and Drug Safety may have an impact on the designation of an obesity treatment drug of concern for misuse.
The obesity treatment ingredients that the Ministry of Food and Drug Safety intends to designate as drugs of concern for abuse include preparations containing liraglutide, semaglutide, and terzepatide. These are Saxenda, Ugobi, and Maunjaro ingredients, respectively.
Although efpeglenatide, an ingredient in Ephe, is not included in this, some industry analysts believe that designating an obesity treatment drug as a drug at risk of abuse could shrink the market and harm the will to develop domestically produced new drugs.
The Ministry of Food and Drug Safety announced on the 13th that it will continue to pursue the designation of drugs of concern for misuse after pointing out in a government audit that prescriptions for obesity treatments are rapidly increasing and that there are cases of pregnant women and children being prescribed them.
Minister of Food and Drug Safety Oh Yoo-kyung said, “During the review process, we will provide further explanation on the need to designate drugs of concern for misuse.”
In Korea, the distribution of GLP-1 type obesity treatment drugs is rapidly increasing. The circulation volume in October 2024 was 160,000, but in July of this year, it was about 3.12 million, a 20-fold increase.
If a drug is designated as a drug of concern for abuse, the corresponding statement must be written on the container or packaging. Additionally, even in areas exempt from the division of medicine, you must have a doctor's prescription to purchase medicine.
