Opposition to labeling obesity drugs as 'misuse drug'

Japan and Australia are focusing on monitoring distribution and prescription

Concerns are raised that regulating the drug itself could expand illegal distribution, as well as blocking patient access

AI-generated image

Voices are growing against the plan to designate GLP-1 obesity treatments, such as Wegovy and Mounjaro, as "high potential misuse and abuse." 

Critics point out that such a designation could instead drive patients toward illegal distribution channels.

Analysis suggests that other countries are already putting effort into establishing an environment for safe use by monitoring distribution and prescription, rather than regulating the drug itself.

On the 8th, the Ministry of Food and Drug Safety (MFDS) will discuss whether to designate these treatments through the Central Pharmaceutical Affairs Advisory Committee (CPAC).

Currently, this category includes erectile dysfunction treatments, premature ejaculation treatments, and anabolic steroids. 

Once designated, the phrase "high potential misuse and abuse" must be displayed on the product packaging, and sales without a prescription are prohibited even in areas exempt from the separation of prescribing and dispensing.

The MFDS's push for this designation is due to issues such as non-face-to-face prescribing, online black-market transactions, and indiscriminate off-label use, following the immense popularity of Wegovy and Mounjaro. 

Following discussions in last year's parliamentary audit, health authorities have been reviewing this designation.

However, the industry is voicing concern that the designation could lead to illegal distribution, resulting in a balloon effect.

However, the industry warns that labeling these drugs as potentially misused could shrink the patient base and prevent those who genuinely need treatment from receiving it.

They argue that global trends focus on regulating the distribution and prescription stages rather than the drugs themselves.

In Japan, as the prescribing of Ozempic (semaglutide) for obesity purposes increased, guidelines were established for prescribing institutions. 

According to an analysis conducted by the University of Tokyo research team of Japanese medical institution websites, institutions that advertised non-reimbursed prescriptions for GLP-1 receptor agonists exhibited significantly lower information quality. Furthermore, a large majority of these institutions were found to violate pharmaceutical advertising guidelines.

Japan's Ministry of Health, Labor and Welfare (MHLW), when approving health insurance coverage for Wegovy in February 2024, set strict standards for prescribing institutions and patient lifestyle habits.

Australia is also focusing on blocking unofficial distribution channels. 

From October 2024, Australia's Therapeutic Goods Administration (TGA) excluded GLP-1 drugs from the pharmacy compounding exemption. 

The system is designed to allow pharmacies to prepare similar drugs in response to drug shortages or to provide customized preparation for a specific patient.

They also intensified advertising regulations, imposing fines of approximately 198,000 AUD (about 200 million KRW) for illegal advertisements on telehealth platforms.

Japan and Australia have clear medical evidences and are focusing on monitoring illegal distribution and prescriptions, rather than designating obesity drugs that are approved by the regulatory authority as having the potential to be misused and abused.

The WHO also emphasized 'regulated distribution networks, prescriptions by qualified medical professionals, and strong supervision' in its December 2023 global guidelines to counter the spread of counterfeit and substandard GLP-1 products.

An industry official stated, "Major countries are setting standards for eligible prescribing institutions and restrictions on non-face-to-face prescriptions," adding, "They are putting effort into monitoring whether prescriptions align with BMI and comorbidities." 

The official added, "The Korean government and medical community should develop systematic management plans that block cosmetic use while protecting patient access for those who truly need treatment."

There is also concern that the negative stigma of being a "high potential to misuse and abuse" could affect severely obese and type 2 diabetic patients. 

Another industry official stated, "Designation of 'high potential to misuse and abuse' mandates labeling, and the label points at all obesity patients. Not only those with severe obesity but also type 2 diabetic patients would receive medication stamped with 'potential to misuse'."

Furthermore, there is a risk that patients who find it harder to obtain legitimate prescriptions may turn to unverified online purchases or illegal distribution channels. With cases of fraud and harm from illegal transactions already present in Korean online communities, critics fear that the official designation could expand this illegal market.