Contaminated fentanyl: former ANMAT head cleared minister Lugones and lashed out at his subordinate

Nélida Agustina Bisio, former administrator of ANMAT, spent more than four hours at the federal courts in La Plata to expand her testimony in the contaminated fentanyl tragedy case, a proceeding in which she is named as a defendant. According to judicial sources, the former head of the agency denied responsibility for the lack of oversight of the Ramallo and HLB Pharma laboratories, from which the defective medicines originated.

She deflected responsibility onto one of her subordinates, the director of the National Medicines Institute (INAME), Gabriela Mantecón Fumadó, who is also charged in the case. "I reject that everything happening at ANMAT was within my knowledge," Bisio said. She also distanced Health Minister Mario Lugones from any potential consequences of this health scandal: in her lengthy statement before Judge Ernesto Kreplak and prosecutor Laura Roteta, she clarified: "When I referred to 'Mario' in phone conversations and chats, it was because he was asking me how the proceedings against the inspected laboratories were progressing. He did so because in the periodic conversations we had, he always expressed his intention to tighten and accelerate health oversight measures against the laboratories involved."

Bisio and Mantecón Fumadó were detained two weeks ago at the request of the prosecution and in a procedure authorized by the judge. After two days and upon payment of a 75-million-peso bail each, they were released but remain under investigation.

The case being handled by Federal Court No. 3 in La Plata seeks to determine responsibility for the deaths of 90 people who received fentanyl at various healthcare centers across the country beginning in March 2025. An additional 44 people suffered worsening health conditions as a result, according to a study conducted by the expert advisory body of the Supreme Court of Justice.

The contaminated fentanyl scandal, which broke following a study carried out at the Hospital Italiano de La Plata, led to the arrest of Ariel Garcia Furfaro, owner of Ramallo and HLB, his brother Diego, and ten other executives and technicians from the companies that manufactured this opioid, which is used as an anesthetic for critically ill patients.

"In general terms, she maintained the arguments she had submitted in writing," sources at the La Plata courts told Clarín. "She again attempted to justify her actions," they added.

Last week, Bisio added a 117-page written statement to the case file. In one section of her presentation, she explained that working meetings were held every two weeks at the Ministry of Health, attended by Lugones, to keep him informed of ANMAT developments. "At one of those meetings, he gave express instructions to close or suspend any laboratory found to be in an identical situation of deficiencies to those detected at the Ramallo laboratory."

This is why — the former official clarified — "when she asked the Director of INAME (Gabriela Mantecón) whether the situation at HLB Pharma 'warranted CLOSURE' after reading a background report, it was to comply with the minister's instruction to proceed with the suspension of any facility with serious irregularities."

The doctor who worked more than 30 years at the official body said that "not everything that happens at ANMAT can be known by the director." She asserted along those lines: "As National Administrator, she was at the apex of a highly decentralized and specialized administrative macrostructure of more than 1,100 agents and 110 organizational units. It is materially impossible for the highest authority to oversee every desk and every space."

However, she shifted part of the burden onto a subordinate. She attributes to Mantecón Fumadó the technical-operational and decision-making responsibility for the key events that preceded the contaminated fentanyl crisis. The central argument is that INAME "operated with autonomy and that it was its national director who made the decisions to delay or halt the main preventive measures" regarding the laboratories in question. She attributes to her a lack of decisiveness and delays in certain procedures.