The Growing Threat of Counterfeit GLP-1 Medications – and the Role of VRS in Detection

The soaring popularity of GLP-1 receptor agonists for weight loss and diabetes has unfortunately attracted a dangerous shadow market: counterfeit versions of these important medications. GLP-1 receptor agonists are a class of medications that mimic the effects of a natural hormone in the body called glucagon-like peptide-1 (GLP-1). This hormone helps to lower blood sugar, slow down digestion, and reduce appetite. Medications like semaglutide (Ozempic, Wegovy) and liraglutide (Victoza, Saxenda) belong to this class and are in high demand. This issue has been highlighted in the news again recently, with reports just in the last few days detailing the continued emergence of sophisticated counterfeit GLP-1 pens and vials making their way into the supply chain, posing a risk even to companies with established quality control procedures.

Many times, the challenge lies in the visual similarities to authentic products and the speed at which these counterfeits can spread. This situation highlights the potential for patients to receive ineffective or harmful substances.

For this reason, we continue to be a staunch advocate of the Verification Router Service (VRS) function. While the Drug Supply Chain Security Act (DSCSA) mandates the verification of product identifiers in specific circumstances, VRS is an industry-developed system that facilitates efficient verification by connecting users directly with manufacturers. By scanning the unique identifier on a GLP-1 medication and querying the VRS network, distributors and dispensers can quickly confirm its authenticity.

How VRS Aids in Identifying Counterfeits:

• Direct Verification with the Manufacturer: VRS provides a direct link to the manufacturer, offering a more reliable verification method than relying solely on packaging or paper documentation.  Consider that companies that are now dealing with counterfeits, who had impeccable paperwork and data files.
• Faster Detection and Alerts: Real-time verification through VRS can identify suspect products earlier in the supply chain. A failed verification serves as an important alert, prompting further investigation.
• Enhancing Patient Safety: By enabling more rapid identification of potentially counterfeit medications, VRS plays a crucial role in safeguarding patients from substandard or dangerous treatments.
• Protecting Brand Reputation: For legitimate manufacturers, VRS helps to ensure the integrity of their supply chain and protect their brand from the negative impacts of counterfeits.
• Supporting Regulatory Action: Information from VRS verifications can contribute to the identification of counterfeit trends, aiding the FDA and other regulatory bodies in their efforts to combat illicit drug distribution.

What Steps to Take:

• Ensure your organization's systems are integrated with a VRS network to meet DSCSA verification requirements effectively. Encourage your suppliers to participate in VRS, as an industry-supported tool.
• Implement thorough verification protocols for all drug products, with a particular focus on high-risk medications like GLP-1 agonists.
• Train staff on the importance of DSCSA verification and the proper use of VRS, emphasizing the significance of negative verification responses as a trigger for investigation.
• Establish clear internal procedures for investigating suspect products identified through VRS and for directly notifying the FDA using Form FDA 3911 if a product is confirmed as illegitimate.
• Stay informed about the latest information regarding counterfeit medications and best practices for DSCSA compliance.

By leveraging the capabilities of VRS to meet DSCSA verification mandates and by adhering to proper reporting procedures, the pharmaceutical industry can strengthen its defenses against counterfeit drugs and better protect patient health.