GLP-1 obesity drug restrictions face full regulatory review

Only proposal referred for full review following Sept. 21 preliminary screening Committee

Vice Chair Yong-Jin Park questions appropriateness of restrictions...Industry calls for complete reassessment

The Ministry of Food and Drug Safety's plan to designate GLP-1 obesity treatments as drugs with a high risk of misuse or abuse has encountered a major setback.

The proposal was referred for full review following a preliminary screening by the presidential Regulatory Rationalization Committee (formerly the Regulatory Reform Committee). Public criticism from a senior committee official, coupled with the recent approval of a domestically developed obesity drug, has raised the possibility that the proposed restrictions could be withdrawn or substantially revised.

According to government and industry sources on the 12th, the MFDS proposal to amend the Regulation on the Designation of Drugs with a High Risk of Misuse or Abuse was formally referred for full review at the 29th preliminary screening of newly introduced or strengthened regulations that was held on Sept. 21.

Of the 15 proposals considered, 14 completed regulatory review through the simplified procedure. Only the proposal to newly designate GLP-1 obesity treatments (liraglutide, semaglutide and tirzepatide) was referred for full review. The decision suggests that the committee considered the measure to have broader implications and potentially contentious social consequences beyond a routine assessment of regulatory requirements.

The MFDS had initially secured the Central Pharmaceutical Affairs Council's endorsement in April and completed the administrative notice process in June. It had planned to finalize the revised notice in September, citing the need to prevent sales without prescriptions in areas exempt from the separation of prescribing and dispensing, among other concerns. However, the referral for full regulatory review has disrupted the timetable.

“Different from erectile dysfunction drugs and steroids”...Committee raises objections

Public opposition from the committee's leadership has added momentum to calls for the proposal's withdrawal. Yong-jin Park, vice chair of the Regulatory Rationalization Committee, recently questioned the MFDS policy on social media, arguing that “it would be inappropriate to place obesity treatments under the same regulatory framework as erectile dysfunction drugs or steroids,” suggesting that the proposal warranted a fundamental reassessment.

Park said, “Just because a drug carries a risk does not necessarily mean that labeling the drug itself as prone to misuse or abuse is the best policy.” He also noted that such an approach runs counter to the growing international recognition of obesity as a chronic metabolic disease, including by the World Health Organization (WHO).

His argument suggests that Korea should focus, as other major countries do, on managing prescribing guidelines within the healthcare system and regulating illegal and counterfeit distribution. Critics warn that imposing a blanket regulatory label could instead produce a “balloon effect (displacement effect),” pushing patients toward illicit markets or older psychotropic obesity medications that carry greater risks of dependence.

Recent changes in the Korean market have also emerged as a factor challenging the rationale for the proposed restrictions. Hanmi Pharmaceutical recently obtained MFDS marketing approval for its independently developed obesity treatment Efe (efpeglenatide), Korea's first domestically developed GLP-1 obesity drug and the country's 45th homegrown new drug.

Critics argue that requiring drugs in the same class to carry a misuse-or-abuse warning immediately after a Korean pharmaceutical company has commercialized a treatment for a chronic disease through years of R&D could serve as a barrier to the new product's market entry.

An industry official said, “A regulation intended to curb the overheated market for imported obesity drugs from multinational companies could end up raising prescribing barriers for a newly developed Korean drug and undermining incentives for domestic R&D. Mandatory labeling of product packaging with a warning that the drug is prone to misuse or abuse could also create unnecessary reluctance and feelings of guilt among patients with chronic obesity who may seek treatment with the domestically developed drug.”

MFDS stands by original proposal…full review result gains attention

The MFDS maintains that the proposed designation is necessary to prevent unlawful sales without prescriptions in exempt areas and maintain orderly distribution. The ministry maintains its position to proceed with regulatory reviews while upholding the original administrative notice draft, aiming to block illegal non-prescription sales in designated exempt areas and establish distribution order.

An industry official said, “The government should either withdraw the designation and instead strengthen prescription monitoring through the Drug Utilization Review (DUR) system and enforcement against illegal distribution, or limit the restrictions to distribution management in exempt areas without imposing mandatory warning labels on packaging.”

Therefore, attention now turns to the full review by the Regulatory Rationalization Committee's Public Livelihood Subcommittee, which will weigh the MFDS's rationale for the original proposal against calls from the pharmaceutical industry and some medical professionals for a less restrictive approach.