Ministry of Food and Drug Safety's 'misuse-prone drug' designation referred to full review

Lawmakers Park Yong-jin, Shin Hyun-young call move 'stigmatizing' and a violation of patients' treatment rights

MFDS chief tells national audit: Office for Government Policy Coordination reviewing the proposal

Wegovy and Mounjaro, two leading GLP-1 class drugs. [Reuters]
Wegovy and Mounjaro, two leading GLP-1 class drugs. [Reuters]

South Korea's effort to classify GLP-1 obesity drugs as "misuse- and abuse-prone medications" has reached a critical juncture after a government regulatory body intervened to slow the process.

The Presidential Committee on Regulatory Reform singled out the proposal for a full review — the only one among a recent batch of regulatory items to face that level of scrutiny — while politicians have sharpened their criticism, calling it little more than a stigmatizing label.

Ministry of Food and Drug Safety Commissioner Oh Yu-kyung told the National Assembly's Health and Welfare Committee national audit on Tuesday that the GLP-1 obesity drug designation is "currently under regulatory review by the Office for Government Policy Coordination."

At a recent preliminary screening of new and strengthened regulations, the Presidential Committee on Regulatory Reform referred the ministry's proposed amendment — which would add the "misuse- and abuse-prone medication" label to GLP-1 obesity drugs — to a full review. Of the 15 regulatory items submitted, 14 were cleared through an expedited process. The proposal to newly designate three GLP-1 active ingredients used in obesity treatment — liraglutide, semaglutide and tirzepatide — was the sole item flagged for in-depth examination, a sign the committee judged it to carry significant societal impact and potential for conflict.

The ministry's core rationale for the designation is to close gaps in the retail distribution chain. Under current pharmaceutical law, pharmacies in areas exempt from the mandatory doctor-pharmacist separation system may dispense prescription drugs without a prescription for up to a three-day supply.

Domestic imports of GLP-1 obesity drugs jumped from about 169.9 billion won ($127 million) in 2024 to 1.07 trillion won in 2025, and over the same period the supply of Wegovy flowing into pharmacies in those exempted areas surged 975.7 percent. Against that backdrop, concerns have mounted over inappropriate prescriptions for children and pregnant women, illegal online sales, and the practice of splitting injection pens among multiple users. The ministry's plan is to require mandatory labeling of "misuse- and abuse-prone medication" on packaging and to ban prescription-free sales in exempted areas entirely.

The committee's intervention, however, has sharply shifted the mood. Park Yong-jin, vice chairman of the Presidential Committee on Regulatory Reform, said it was worth asking "whether slapping a label on the drug itself is the best policy response just because there are misuse concerns," adding that it was "inappropriate to lump obesity drugs into the same regulatory framework as erectile dysfunction treatments or steroids." Critics noted the move runs counter to the global trend in which the WHO has classified obesity as a chronic disease and added GLP-1 therapies to its list of essential medicines.

Shin Hyun-young, a Democratic Party of Korea spokesperson and a physician by training, said "branding a drug itself as a misuse product simply because it is widely used and abused is a blunt, unscientific response that has no place in regulatory science." Shin said the focus should be on "auditing the distribution system on the ground — the clinics churning out excessive prescriptions and the pharmacies dumping drugs at cut-rate prices — rather than cracking down on the drug itself," warning that stigmatizing the medication would "only raise the psychological barrier for chronic obesity and diabetes patients who genuinely need treatment."

The Korean Diabetes Association, a professional body, also urged caution. In a statement released shortly after the ministry's administrative notice, the association said it "sympathizes with the policy goal of preventing misuse and abuse, but assigning a label without concrete administrative guidelines is administrative convenience." It warned the move "could cause unnecessary anxiety and stigma for patients who require the drug as an essential treatment for metabolic disease, ultimately undermining treatment adherence."

The recent approval of Hanmi Pharm's domestically developed new drug efpeglenatide — the 45th original drug approved in South Korea — has added another variable to the market. The ministry's proposed regulation targets three foreign-origin active ingredients, so efpeglenatide would not immediately fall under the legal restrictions. But industry insiders worry that if negative perceptions spread to the entire GLP-1 class, it could undermine market uptake and dampen research and development momentum for a homegrown drug that has only just launched. The prospect of future disputes over regulatory parity — and whether efpeglenatide might eventually be added to the list — is an additional latent concern.

The procedural delays and controversy also came up at the national audit. Commissioner Oh said she would "explain more fully the necessity of the misuse- and abuse-prone drug designation during the Office for Government Policy Coordination review process." She effectively acknowledged that the original target of completing the official notice by September had been derailed by the regulatory review, and reaffirmed the ministry's intent to proceed — though she offered no specific timeline for when the final notice might be issued.

The ministry maintains its position of pressing ahead with the original proposal in the interest of managing distribution in exempted areas and protecting public safety. However, a compromise outcome from the full review — one that eases the mandatory packaging warning while selectively tightening the ban on sales in exempted areas and strengthening on-site monitoring — cannot be ruled out. With health authorities defending the measure as necessary to curb misuse and critics pushing back against overregulation, the industry and medical community are watching closely for the regulatory review committee's final decision.


silverpaper@heraldcorp.com