The June 2024 issue of Vanity Fair included the provocative headline: “Why Counterfeit Ozempic Is a Global-Growth Industry." [1] Novo Nordisk’s patented drug Ozempic® (semaglutide injection) was first approved by the FDA in 2017 for the treatment of type 2 diabetes.[2] A few years later, clinical trials demonstrated that Ozempic® could also be used for weight loss in individuals without diabetes who had previously struggled to lose weight.[3] News of the “miraculous weight loss” achieved with Ozempic® (and its sister drug Wegovy®) led to widespread demand for the drug and global shortages.[4]
Drug shortages create an opportunity for criminals to profit by making and selling counterfeit drugs. Counterfeit drugs include those that have been diluted, relabeled, or replaced with cheaper ingredients.[5] Among the downsides of counterfeit drugs, they (1) risk consumer health and safety, (2) deprive owners of technology of the commercial benefits of their inventions, (3) harm the brands of the real drugs, and (4) discourage innovation.[6]
Many countries have enforcement mechanisms for counterfeit drugs. In the United States, the Drug Supply Chain Security Act (DSCSA) was enacted in 2013 to address the dangers of illicit and counterfeit drugs by establishing requirements for electronically tracing prescription drugs as they move through the supply chain from manufacturers to distributors to pharmacies, and ultimately to patients.[7] However, the DSCSA is not yet fully in effect, and the electronic prescription tracking system has been delayed.[8] Additionally, patients can currently obtain a compounded version of Ozempic.[9] Compounded drugs are not FDA-approved[10] and are exempt from the DSCSA.[11] While significant efforts are made to identify and remove counterfeit medications from the market, there seems to be less focus on identifying the manufacturers of these counterfeit drugs. This leaves patent holders without the option to sue the manufacturers for patent infringement and recover their losses.
While numerous studies have indicated that there may be further health benefits to Ozempic®,[12] the widespread popularity of the drug for weight loss has led to increased counterfeiting in the market. Fake versions of Ozempic® have been identified in Europe, the Americas, and the Middle East.[13] In June 2024, the World Health Organization issued an alert warning of the risks to consumer health associated with counterfeit Ozempic® due to incorrect dosage, contamination with harmful substances, or the use of unknown or substituted ingredients.[14] One example of these risks is the numerous reports of adverse and life-threatening reactions to fake Ozempic®, which was actually relabeled insulin.[15] Additionally, the FDA has warned that the sterility of the injection needles cannot be confirmed, which presents an increased risk of infection.[16]
Editor: Brenden S. Gingrich, Ph.D.
[1] https://www.vanityfair.com/news/story/counterfeit-ozempic-global-growth-industry
[2] https://www.prnewswire.com/news-releases/novo-nordisk-receives-fda-approval-of-ozempic-semaglutide-injection-for-the-treatment-of-adults-with-type-2-diabetes-300567052.html#:~:text=OZEMPIC%C2%AE%20(semaglutide)%20injection%200.5%20mg%20or%201%20mg%20was,adults%20with%20type%202%20diabetes.
[3] https://www.nejm.org/doi/full/10.1056/NEJMoa2032183
[4] https://www.vanityfair.com/news/story/counterfeit-ozempic-global-growth-industry
[5] Id.
[6] “Securing innovation: Tackling the 21st century epidemic of counterfeiting and intellectual property piracy”, International Bar Association World Life Sciences Conference, Roundtable Discussion, May 29, 2024. Counterfeit drugs have also been reported to fund crime organizations or international terrorist groups. https://www.wipo.int/edocs/mdocs/aspac/en/wipo_ipr_pnh_11/wipo_ipr_pnh_11_ref_t2.pdf.
[7] https://www.gs1us.org/supply-chain/standards-and-regulations/drug-supply-chain-security-act
https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
[8] https://www.pharmacytimes.com/view/fda-announces-delayed-enforcement-of-dscsa-to-2024
[9] https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss
[10] https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
[11] https://ncpa.org/newsroom/qam/2023/08/15/compounds-and-raw-materials-compounds-exempted-dscsa#:~:text=Attention%20all%20compounders%3A%20just%20a,are%20exempt%20from%20the%20DSCSA.
[12] https://www.scientificamerican.com/article/combining-ayahuasca-compound-with-drugs-like-ozempic-could-help-treat/
[13] Id. and https://www.msn.com/en-us/money/other/fake-ozempic-is-circulating-in-europe-and-americas-who-warns/ar-BB1oApNF
[14] https://www.who.int/news/item/19-06-2024-medical-product-alert-n-2-2024--falsified-ozempic-(semaglutide)
[15] Id.
[16] https://content.govdelivery.com/accounts/USFDA/bulletins/3813bc8
