Vanesa Petrillo The investigation into contaminated medical-use fentanyl that has killed at least 96 people in Argentina has turned its attention to the role state regulators played in the debacle.
Judiciary sources confirmed to Herald sister publication Ámbito that Judge Ernesto Kreplak has ordered searches in food and drug regulator ANMAT and medication institute INAME, looking for cell phones and documentation. The homes of agency administrators will also be raided.
The goal, judiciary sources added, is to preserve documentary evidence, as well as cellphone records of officials involved, in connection to “potential responsibilities state-health authorities may have had in the production and commercialization” of the fentanyl, as well as in the failure to have it all recalled.
The senior management team of the pharmaceutical company and laboratory that produced the contaminated fentanyl, HLB Pharma and Laboratorios Ramallo, were arrested in late August on charges of quality deviation, as well as suspicions some of the product was sold on the black market.
“Negligence, collusion, or complicity”
According to the prosecution, state regulators could have committed “negligence, collusion, or complicity” in the contaminated medical-use fentanyl case. Ariel García Furfaro and nine other executives and technical managers of the companies involved in producing the contaminated fentanyl are all under arrest.
The government removed the ANMAT official who had direct responsibility for overseeing the laboratory from her post once those arrest warrants were made public. Agency head Nélida Bisio, however, stayed on and was backed by Health Minister Mario Lugones. Her home address is on the list of locations set to be searched.
ANMAT inspected Laboratorios Ramallo between November 28 and December 12 of last year.
The contaminated fentanyl was produced on December 18, six days after the inspection was completed. It was not until February 10 that the laboratory was informed that it could not continue production “until it complied” with the submitted observations and made the corrections. It was not until May that all activity by HLB Pharma and Laboratorios Ramallo was suspended.
The agency’s report details that between November 28 and December 12, 2024, inspectors from the National Institute of Medicines detected “significant deficiencies classified as critical and major.” Not only did ANMAT fail to immediately shut down the laboratory, but it also failed to order the preventive withdrawal of the batches manufactured after the faults were found.