As the Ministery of Food and Drug Safety moves to designate obesity treatments in the glucagon-like peptide-1 (GLP-1) class, including Wegovy and Mounjaro, as "medicines of concern for misuse and abuse," the medical community and the pharmaceutical industry are voicing opposition and concern in quick succession.
They agree on the need to curb misuse and abuse of obesity drugs, but say the overall impact on patient access to treatment, social perceptions, international public health trends, and the new drug development environment must be reviewed comprehensively.
The Ministery of Food and Drug Safety has given administrative notice of a revision to the "regulation on designating medicines of concern for misuse and abuse" to newly include GLP-1 obesity treatments such as Wegovy (ingredient semaglutide) and Mounjaro (ingredient tirzepatide), and will collect opinions through the 26th.
In response, major medical societies and industry have reportedly submitted opinions one after another.
The medicine-of-concern designation system is a scheme under which the Ministery of Food and Drug Safety separately designates and manages certain drugs when social problems or risks to public health are feared due to their misuse and abuse.
Drugs designated under the system must carry related markings on product containers or packaging, and cannot be sold without a physician's prescription even in areas exempt from the separation of prescribing and dispensing. They are also subject to monitoring of prescribing status through the Drug Utilization Review (DUR) service of the Health Insurance Review & Assessment Service (HIRA).
The Ministery of Food and Drug Safety is reviewing the designation as a regulatory measure in light of rising demand for obesity treatments and factors such as cosmetic-use demand and online transaction.
However, voices in the medical field said the regulation would not help treat obesity.
They worry that attaching the label "medicines of concern for misuse and abuse" could instead deepen social stigma toward people with obesity or have the side effect of discouraging treatment.
According to the Korean Academy of Family Medicine, the World Health Organization (WHO) designated GLP-1 treatments as essential medicines and recommended them as treatments for adults with obesity, after which countries have advanced policies to improve patient access on the premise of appropriate use and to strengthen management systems within formal frameworks.
Kim Sun-hyeon, a professor at Catholic Kwandong University International St. Mary's Hospital who serves as the obesity director at the Korean Academy of Family Medicine, said, "If a plan to designate GLP-1 obesity treatments as medicines of concern for misuse and abuse moves forward in Korea, there needs to be careful review with full consideration of the impact on patient access to treatment and on clinical practice."
Kim noted, "Obesity in the GLP-1 class remains a chronic disease with significant social prejudice and stigma," adding, "Negative perceptions of obesity treatment impose psychological burdens on patients and make it difficult to start or continue therapy, which can ultimately lead to worsening health."
Industry is also on alert over the possibility of new regulations as domestic development of novel obesity drugs moves into full swing.
Hanmi Pharmaceutical is under review for marketing authorization of Efpeglenatide, and HK inno.N is conducting phase 3 trials of Ecnoglutide. Celltrion, Samsung Bioepis, Daewoong Pharmaceutical, Ildong Pharmaceutical, D&D Pharmatech, ENCell, and Proteina are devoting themselves to developing novel obesity drugs using various technologies.
The industry is watching how domestic regulations might affect the future development of homegrown obesity drugs and market formation, given the view that the global obesity treatment market is still in an early growth stage.
Choi Hyung-jin, a leading GLP-1 researcher and a professor at Seoul National University College of Medicine, said in an interview with ChosunBiz last year that "the obesity treatment market is still the Wild West," adding, "there is still ample opportunity for latecomers." The point is that the market for developing obesity treatments has substantial growth potential because novel obesity drugs can continue to evolve beyond GLP-1 into GIP, triple agonists, bioelectronic medicines, and digital therapeutics.
In response to rising demand for obesity treatments, major countries overseas are mainly strengthening management systems by focusing on prescribing and distribution controls.
The World Health Organization (WHO) last year added GLP-1 treatments to its essential medicines list and issued guidelines for adults with obesity. At the time, WHO proposed building regulated distribution networks, clinician prescribing, patient education, and tighter oversight as measures to counter the spread of falsified and substandard medicines.
The United Kingdom, in response to increased online prescribing of obesity treatments, is strengthening patient verification procedures, and the Medicines and Healthcare products Regulatory Agency (MHRA) is cracking down on illegal obesity drug manufacturing facilities and blocking the distribution of counterfeit medicines.
The U.S. Food and Drug Administration (FDA) is also ramping up enforcement against illegal online sales and distribution of counterfeit medicines related to semaglutide and tirzepatide. Australia's Therapeutic Goods Administration (TGA) is implementing measures restricting unapproved compounded copies of GLP-1 drugs.
A pharmaceutical industry official said, "If the goal is patient (public) safety, I believe regulatory capacity should focus, as overseas, on strengthening controls over illegal and counterfeit drug distribution, such as knockoff Wegovy and fake Mounjaro, rather than on regulating newly approved drugs whose efficacy and safety have been verified."
The Ministery of Food and Drug Safety is said to be planning to review the opinions collected through the 26th and to discuss the agenda at a Regulatory Reform Commitee meeting in July.