Latin America Roundup: COFEPRIS suspends manufacturer after bacterial contamination causes infant deaths

An outbreak of infections with multidrug-resistant Klebsiella oxytoca bacteria has resulted in the deaths of 17 Mexican children, the vast majority of them premature infants, and is believed related to contaminated parenteral nutrition products.

On 22 November, epidemiologists in the state of Mexico received incident reports from a local hospital and initiated an investigation that revealed the infections to be multidrug-resistant K. oxytoca. The state epidemiologists notified Mexico’s health secretariat, and Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) initiated an investigation that revealed cases in three more hospitals.

On 4 December, COFEPRIS issued a national alert advising all hospitals against the use of parenteral nutrition products made by one manufacturer in the city of Toluca. Days later, Mexican President Claudia Sheinbaum said in a news conference that COFEPRIS had ordered the manufacturer’s entire production suspended and was exploring other sanctions.

An inspection by COFEPRIS of the Toluca plant did not reveal the source of the infection, according to a 7 December statement by Mexico’s health secretariat. However, there appears to be little doubt that the parenteral nutrition products in question were the source of the fatal infections. Since the nationwide alert was issued, no new infections have been reported, according to health officials.

The attorney general’s office in the state of Mexico has opened its own investigations into the deaths of the children.

Press conference (Spanish)

Top Brazilian regulators reach end of terms

Brazil’s two top regulators are departing this month, as their terms come to an end, according to a statement by the Brazilian Health Regulatory Agency (ANVISA).

Agency Director Antonio Barra Torres and Deputy Director Meiruze Sousa Freitas both took their current posts in November 2020. They helped guide the agency through contentious political battles during the COVID-19 pandemic, when Brazil’s then-president, Jair Bolsonaro, adopted a position of vaccine skepticism, downplaying deaths from COVID-19 and questioning ANVISA’s integrity in authorizing vaccines for children.

“During my term, I had the honor of collaborating with the guardians of science and ethics, among [them] the very dedicated team at ANVISA, to face the regulatory challenges that the COVID-19 pandemic imposed on us,” Freitas said in a farewell statement to her agency colleagues, according to the Brazilian news outlet g1. “Even in the face of significant obstacles, we managed to guarantee the Brazilian population faster and safer access to vaccines, medicines, and biological products, in addition to improving our regulatory processes, making them more agile and transparent.” Moreover, she said, “we fought against the fake news that harmed Brazilians so much.”

Outgoing ANVISA director Barra Torres was similarly steadfast during the pandemic and even demanded publicly that Bolsonaro recant his attacks against the agency, g1 reported.

Brazil president Luíz Ignacio Lula da Silva has yet to announce who will replace the departing regulators.

g1 (Portuguese)

ANVISA publishes competitiveness strategy for clinical trials, while US Chamber of Commerce highlights ‘staffing crisis’

Brazil’s ANVISA agency has released a comprehensive report summarizing its goals for clinical trials in the coming years. Outgoing Deputy Director Freitas contributed an introductory essay stating that “the role we envision for ANVISA goes beyond protecting public health to act as a catalyst for innovation, ensuring in the not-so-distant future Brazil’s competitiveness in the global scenario of new medicines.”

The document, published 11 December, drew attention to Brazil’s multi-ethnic population, something desirable in clinical research; its well qualified medical professionals; the possibility to conduct trials within a large and unified public health system; and its sizeable market for pharmaceutical products.

ANVISA said its recent efforts to strengthen Brazil’s regulatory environment and promote clinical research were inspired by other agencies’ initiatives to accelerate review of innovative treatments, among them the US Food and Drug Administration’s Breakthrough Therapy and Real-Time Oncology Review programs as well as the UK’s Clinical Trials Acceleration Programme. In May, Brazil’s rules governing clinical trials were overhauled, both to enhance research participant protections and to streamline the assessment process and attract investment.

On 9 December, the US Chamber of Commerce, which advocates for US business interests, published an op-ed by Leonardo Abranches, its Brazil advisor, pointing to a looming staffing crisis at ANVISA that stands to get in the way of its plans. The agency’s “ability to maintain its high standards, and its reputation as a global reference national regulatory authority … is under threat,” Abranches wrote, “With repercussions that extend far beyond Brazil’s borders.”

The problem, according to Abranches, is that at 500 ANVISA employees, or roughly a quarter of its workforce, are expected to retire this year, and only 50 replacements have so far been authorized. “For an organization already operating below optimal staffing levels, this reduction is expected to create bottlenecks in critical areas such as product approvals, inspections, and border control,” Abranches wrote. “With 1,604 current civil-service employees complemented with 400 support staff, but with a need for at least 1,250 additional staff, ANVISA’s ability to fulfill its mandate is at risk.”

Brazil is a key trading partner for the US, Abranches wrote, “With billions of dollars in medical products exchanged each year,” and ANVISA’s effectiveness and efficiency “are a critical foundation to a competitive Brazilian health industrial complex.” Abranches recommended specific steps for the Brazilian government to take, including enacting legislative reforms to bolster staffing at ANVISA, with at least 600 new hires in the short term. He also advised that Brazil seek to modernize the agency’s IT systems and use artificial intelligence to streamline processes.

US Chamber of Commerce

DR touts joint effort with industry to improve production standards

The Dominican Republic’s General Directorate of Medicines, Food and Health Products (DIGEMAPS) on 3 December announced a partnership with the country’s pharmaceutical trade group, INFADOMI, for joint workshops on new quality standards to boost country’s pharmaceutical manufacturing sector, Dominican news outlets reported. In the past five years, Dominican manufacturers have seen about $300 million in investments, mainly to support compliance with WHO standards and harmonization initiatives. “Our objective is to guarantee the sustainable growth of companies and facilitate compliance with international quality and safety standards,” Leandro Villanueva, general director of DIGEMAPS, commented to press.

Diario Digital (Spanish)

Latin America Roundup: COFEPRIS suspends manufacturer after bacterial contamination causes infant deaths

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