Latin America Roundup: DIGEMID director resigns amid IV solution deaths

In February and March, four patients in Peru, including an infant, died after being treated with intravenous saline solutions that contained unsafe concentrations of sodium chloride, while over a dozen more people ended up in intensive care with serious neurological symptoms.

A shakeup followed at DIGEMID. On 31 March, Moisés Mendocilla resigned after nearly two years as the agency’s director and was replaced by Sonia Delgado, a pharmacologist and former device regulator. Delgado lasted only a day before news broke that she held shares in two consulting firms that advise drug companies. Health ministry official Henry Rebaza assumed DIGEMID’s leadership on 2 April. Peru health minister César Vásquez has so far resisted calls for his resignation.

The death of a 71-year-old woman, which occurred on 28 February was not immediately linked to the use of the IV solution until nearly a month later, in part due to delays in the hospital’s reporting. The crisis became apparent after a 46-year-old woman, a 24-year-old woman, and a one-year-old infant all died at different clinics between 20 and 22 March after being treated with the same lot of products from the same manufacturer.

On 24 March, Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) issued an alert about lots of saline solution manufactured by Medifarma, a Peruvian firm that produced about 70% of the IV saline products used in Peru. Some 20,000 units were affected by the manufacturing error, the agency said.

Days later DIGEMID suspended the company’s operations, canceled marketing approvals for its products, and filed a criminal complaint against the company. But public criticism of the agency continued, not least because at least 4,000 of the faulty units remain unaccounted for, lost in the resale chain, according to a 3 April report in the Spanish newspaper El País. The affair, according to El País, “Exposed serious deficiencies in the system of surveillance and control of medicines in Peru.”

To avert critical shortages of IV solutions, DIGEMID has loosened import regulations on 4 April. On 6 April Peru’s health ministry received a large donation of products from neighboring Paraguay, delivered by Peru’s air force.

Peru reliance law sparks controversy

Amid public concern about the country’s pharmacovigilance capabilities, Peruvian legislators passed a new law granting automatic marketing approval for products previously approved by foreign regulators if DIGEMID does not reach a decision within 45 days.

The law, critics said, harks back to reliance policies Peru had embraced in the 1990s that had resulted in a flood of low-quality and contaminated medicines.

The law, which was signed on 3 April, allows Peru to accept decisions by national regulatory authorities in the United States, Australia, the European Union, and several individual European countries, along with those of Japan, South Korea, and Honduras. The law’s reliance provisions were originally aimed at easing the entry of biologic and advanced therapies for rare and orphan diseases and cancers into the Peruvian market. However, late changes to the legislation expanded it to cover a much wider range of products, according to an analysis by the health news outlet Salud con Lupa.

Peruvian medical societies and patient organizations strenuously opposed the law, arguing in a joint letter to lawmakers that it does not stipulate that products be fabricated in countries with high regulatory standards, only marketed. This opens the door for unscrupulous business owners to falsify documents, something that occurred in the 1990s under more permissive laws, resulting in a rash of poor-quality and even contaminated products, they said.

Salud con Lupa (Spanish)

COFEPRIS implements reliance for trial protocols

Regulators with Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) said on 24 March that the agency will recognize some clinical trial protocols approved by selected foreign regulatory authorities.

COFEPRIS will green-light Phase III trial protocols evaluated and approved by the European Medicines Agency, the US Food and Drug Administration, the UK’s Medicines and Healthcare Products Regulatory Agency, and Health Canada. Only one of these agencies needs to approve a protocol for COFEPRIS to recognize it.

The process, described in detail in Mexico’s Federal Gazette, is intended to help speed and prioritize investigations in key public health areas for Mexico, notably diabetes, hypertension, and cancer. Protocols for suspended or canceled clinical trials will not be recognized.

COFEPRIS (Spanish)

INVIMA promotes steadier medicines supplies, cooperation with USP

Regulators with Colombia’s National Institute of Food and Drug Surveillance (INVIMA) laid out a plan to improve the country’s medicines supply amid frequent shortages of generic and essential medicines. Portions of an updated rule, published 25 March, describe the storage and stability studies to be conducted on medicinal products, to better calibrate and optimize their shelf lives. Another key provision allows for manufacturers to change a business location or production site with less interruption if certain conditions are met.

The agency also announced on 7 April that it was continuing, and likely increasing, its ongoing cooperation efforts with US Pharmacopeia this year, seeking “cooperation and technical and scientific support to strengthen the country’s regulatory capacity.”

Statement (Spanish)

Chile’s health minister criticizes Duchenne therapy

Chile health minister Ximena Aguilera said that regulators with the country’s Public Health Institute (ISP) have not confirmed the efficacy of a costly gene therapy for Duchenne muscular dystrophy, a disease that affects primarily young boys.

The therapy, marketed as Elevidys by Sarepta Therapeutics, received accelerated FDA approval in 2023 and is priced at more than $3 million per treatment in the United States. In a press report 26 March, Aguilera was quoted as saying that the Elevidys “has shown results on a molecular level, but not demonstrated evidence of clinical improvement,” and therefore would not be approved by ISP nor made available through Chile’s public health system.

Approximately 800 children in Chile have Duchenne muscular dystrophy and some families have sought treatment in the United States. In a subsequent report, parents of children with Duchenne attacked the health minister’s comments, stating that US regulators would not have approved the therapy, nor would US insurers pay for it, without convincing evidence.

Latin America Roundup: DIGEMID director resigns amid IV solution deaths

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