Contaminated fentanyl: Anmat and a "state cover-up" under criminal investigation

Argentine prosecutors have accused state officials of operating under a "state cover-up" in the ongoing investigation into contaminated fentanyl distributed to hospitals. The probe intensified following the detention of two former high-ranking officials from the National Administration of Medicines, Food, and Medical Technology (Anmat).

The investigation centers on allegations that these former officials, Nélida Agustina Bisio and Gabriela Mantecón Fumadó, deliberately omitted or delayed control measures and product recalls. This inaction allegedly allowed contaminated fentanyl, produced and marketed by HLB Pharma and Laboratorios Ramallo, to reach 54 hospitals and clinics across the country over four months, with the number of affected individuals difficult to determine.

Prosecutors claim that Bisio, former national administrator of Anmat, and Mantecón Fumadó, former director of the National Institute of Medicines (Iname), maintained a "private channel" of communication with laboratory directors. They are accused of advising the companies and leaking information about surprise inspections. Evidence suggests that laboratory directors destroyed sensitive information, and Mantecón Fumadó deleted her WhatsApp chats shortly before leaving her post.

Further details reveal that Mantecón Fumadó allegedly dismissed inspection suggestions from other Anmat departments despite risk warnings surfacing as early as 2023. The delays were significant; technical areas within Iname had requested action against HLB, but Bisio reportedly took 38 days to sign a document that could have halted the distribution of the fentanyl ampoules. This case highlights long-standing issues within Anmat, which has previously faced scrutiny over its regulatory oversight, including past incidents involving the import of ephedrine.

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A state cover-up operated.