“I Don’t Deny General Responsibility”: Ex-Anmat Leader Details Defense in Fentanyl Case

Agustina Nélida Bisio, the former head of Argentina's National Administration of Medicines, Food, and Medical Technology (Anmat), has formally denied bearing equivalent responsibility to that of her former subordinate in the ongoing investigation into contaminated fentanyl. In a 117-page statement submitted to the court in La Plata, Bisio acknowledged her "general responsibility" as the agency's leader but contested that her accountability should be equated with that of Gabriela Mantecón Fumadó, her former subordinate at the National Institute of Medicines (Iname). Both women are implicated in the case involving a potent fentanyl-laced drug that caused a public health crisis last year, leading to numerous deaths and severe health consequences. They were previously detained but are now undergoing the judicial process while out on bail, each having posted a 75 million peso bond. Bisio's defense centers on the specific information she received, its source, its technical elaboration, and the concrete actions she was capable of taking at any given time. Bisio, who has worked at Anmat for 34 years, asserted that she was never involved in laboratory inspections. Her career, she stated, was consistently within the realm of document review concerning medication inserts and clinical pharmacology research. She expressed that matters related to operational control of laboratories and inspections of good manufacturing practices were always outside her direct purview, given the distinct responsibilities of the Iname department. She further defended herself by pointing to the vastness and specialized nature of Anmat, describing it as a highly decentralized administrative macrostructure with over 1140 agents and more than 110 organizational units. Bisio emphasized the autonomy of the Iname, particularly its authority to conduct inspections and implement its own procedures and decisions, including issuing inspection reports and warning letters. She noted that Mantecón Fumadó digitally signed a warning letter to the technical director of Laboratorios Ramallo only in February 2025.

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I do not deny the general responsibility that comes with having headed Anmat.