Latin America Roundup: ANMAT pharmacovigilance official fired amid fentanyl scandal

As the death count from bacterially contaminated fentanyl continues to rise in Argentina, with nearly 100 cases counted by investigators, the pharmacovigilance director at the country’s medicines agency has been ousted.

Mariela Andrea García, the director of post-marketing surveillance and regulation at the National Administration of Drugs, Food and Medical Devices (ANMAT), was severed from her position on 18 August by the country’s health minister. García had held her post at ANMAT for nearly six years. The health ministry has not yet named her replacement.

Though virtually all media outlets reporting on García’s firing have linked it to the fentanyl scandal, ANMAT issued a statement on 19 August claiming that García’s firing was not related to the crisis.

The past week has seen political mudslinging by top officials over whether the former or current government is to blame for the scandal, in which lots of contaminated fentanyl vials, made it into Argentinian hospitals this past Spring. Most of the victims were patients in intensive care.

Laboratorios Ramallo, the company that manufactured the fentanyl, and the products’ license-holder, HLB Pharma, were sanctioned by ANMAT over manufacturing lapses in the months before the crisis came to light. It now appears clear that timelier enforcement action might have prevented the deaths.

A plant inspection conducted in December 2024 detected “critical” and “major” irregularities in manufacturing practices, according to documents obtained by the Argentina business media outlet AgendAR, and others. However, ANMAT’s findings were not made public until 10 February 2025, when the agency ordered production at Ramallo shut down.

The contaminated vials were produced in the interim period, starting just days after the plant inspection took place.

In a message on X dated 14 August, Argentina president Javier Milei, who took office in late 2023, blamed members of an opposition party for having allowed Ariel Garcia Furfaro, the owner of Ramallo and part owner of HLB, to supply drugs to the country’s health ministry when they were in power.

Milei insisted that these “militants” were ultimately to blame for the fentanyl catastrophe. Milei’s opponents, meanwhile, have argued that the president’s deregulatory initiatives and budget cuts have strained the operations of ANMAT and reduced its surveillance capacity.

Statement (Spanish)

Injectable HIV prevention drug approved in Mexico

Mexico’s Federal Commission for the Protection against Sanitary Risks (COFEPRIS) said on 11 August that it approved cabotegravir, a long-acting injectable antiretroviral drug used for pre-exposure prophylaxis (PrEP) against HIV infection. Injectable antiretroviral drugs such as cabotegravir and the newer agent lenacapavir offer a convenient alternative to regimens of oral medications, which need to be taken daily.

COFEPRIS did not say whether there would be restrictions on cabotegravir’s availability, such as limiting it to pilot studies or implementation studies. While the Brazil Health Regulatory Agency (ANVISA) approved injectable cabotegravir in 2023, and thousands of people have received it through ongoing studies, it has yet to be integrated into Brazil’s public health system. Similarly, in Peru, cabotegravir injections are available, but only through studies.

Uptake of HIV prophylaxis is uneven across Latin America and the Caribbean. While many countries, including Mexico, provide free distribution of oral PrEP to at-risk individuals through their health systems, others restrict it to studies or certain specialized clinics. About 400,000 people in Mexico currently are infected with HIV, according to UNAIDS, the United Nations program that aims to end AIDS as a global public health threat.

The World Health Organization has encouraged low- and middle-income countries to approve long-acting injectable forms of PrEP, which have been shown in studies to be superior to oral regimens in preventing HIV infection, largely due to improved adherence.

Recent results from a large, government-led implementation study in Brazil showed injectable cabotegravir to be preferred over oral regimens by more than 80% of at-risk individuals aged 18-30. People taking injectable cabotegravir had 94% adherence during first 48 weeks of the study, and no HIV infections were reported in that group, compared with 9 new infections among participants on oral regimens.

Statement (Spanish)

Brazil prepares for public manufacture of GLP-1 drugs

The Oswaldo Cruz Foundation (FIOCRUZ), Brazil’s national health research institute, announced on 15 August that it had signed technology transfer and development agreements that will allow it to produce the injectable drugs semaglutide and liraglutide for the country’s public health system.

Both agents target the hormone glucagon-like peptide 1 (GLP-1) and are used primarily to treat type 2 diabetes and obesity. Liraglutide no longer has patent protections for these indications in Brazil, while semaglutide will lose its protections next March.

FIOCRUZ said it will not begin production immediately and that the drugs will for now be manufactured on its behalf by the Brazilian pharmaceutical firm EMS. In its statement, FIOCRUZ said that its drug manufacturing arm will begin producing liraglutide and semaglutide once the technology transfers for the synthesis of active pharmaceutical ingredients are completed.

EMS is currently producing two generic versions of liraglutide -- one for obesity and another for diabetes -- and advertising them on its website.

Both drugs were developed and marketed globally by the Danish manufacturer Novo Nordisk. The company has large manufacturing facilities in Brazil and continues to expand operations there, according to its most recent annual report, even as its older GLP-1 drugs come off patent.

Statement

Latin America Roundup: ANMAT pharmacovigilance official fired amid fentanyl scandal

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