Anmat received 10 alerts on deadly fentanyl, but reaction was delayed

Argentine prosecutors and a judge believe that deaths linked to contaminated fentanyl could have been avoided if the National Administration of Medicines, Food and Medical Technology (Anmat) had acted on internal alerts sooner. The investigation centers on alleged negligence by former Anmat officials, particularly concerning fentanyl produced by HLB Pharma in December 2024.

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If the authorities of the National Administration of Medicines, Food and Medical Technology (Anmat) had taken in January of last year some of the measures that the different areas of the National Institute of Medicines (Iname) were requesting for the laboratories that marketed contaminated fentanyl, "no death would have occurred."

According to the prosecution, at least 10 internal alerts were activated within Anmat regarding the contaminated fentanyl. These communications form part of the arguments presented to Judge Ernesto Kreplak as he considers requests for the detention of two former Anmat officials, Gabriela Mantecón Fumadó and Nélida Agustina Bisio. The contaminated drug reportedly caused deaths and left about a hundred patients with sequelae.

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that drug from HLB Pharma, made in December 2024, "would have circulated anyway" without Iname having found out.

Mantecón Fumadó, former director of the National Institute of Medicines (Iname), stated that the production line for HLB's opioid had not been inspected or reported on until the case became public in May of the previous year. She asserted that even if her management had been in place earlier, the drug would have circulated without Iname's knowledge. However, a witness, formerly head of the Department of Inspection and Risk Management, contradicted this, reporting a large number of quality deviation reports for products from both HLB Pharma and Laboratorios Ramallo between 2021 and 2022. This witness stated that after she submitted an alert note in 2023, these notifications ceased reaching her department.

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the production line of said drug [fentanyl] has not at any time been subject to inspection of good manufacturing practices, nor any other type of inspection.

Despite Mantecón Fumadó's claim that her administration found HLB Pharma and Laboratorios Ramallo compliant with manufacturing practices, the Iname has records of nearly 300 administrative files opened between June 2018 and May 2025. These relate to other products from the two laboratories due to quality deviations and regulatory non-compliance, with over 65 drugs failing to meet Anmat's authorized specifications. The investigation continues to reconstruct the events leading to the contaminated fentanyl's market release.

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a "large quantity" of reports for quality deviations in products from both laboratories