Latin America Roundup: Colombia confronts insulin shortage

Officials with Colombia’s National Institute of Food and Drug Surveillance (INVIMA) are grappling with nationwide shortages of both long- and short-acting insulin.

In a statement issued 25 February, INVIMA, which just days before had confirmed Francisco Rossi as its new director, updated on the availability of nine licensed insulin products in Colombia, identifying inadequate or uncertain supplies for four. The products of concern are Humalog and Humulin (Eli Lilly), Tresiba (Novo Nordisk), and Lantus (Sanofi).

The agency cited different reasons for concern depending on the product. With Lantus, INVIMA said a supply issue originating in Germany, where it is manufactured, had resulted in temporary delays that were expected to be resolved “in the coming days.” With Humulin, the marketing authorization in Colombia had expired, according to INVIMA.

The agency also pointed to market factors as responsible for the shortages. “In general, for insulins, there is a significant concentration in the market of single registration holders, meaning that in the event of problems faced by one of these manufacturers, the availability of a product is affected without the possibility of having other suppliers that contribute in a timely manner to its availability,” according to an INVIMA statement. The agency also published an email address to which consumers can report unavailable products.

INVIMA has requested urgent meetings with the manufacturers, according to a report in the newspaper El Tiempo. Complicating matters, Colombia President Gustavo Petro publicly attributed the shortages to an abuse of the health system by people eager to lose weight, apparently confusing insulin with GLP-1 agonists such as semaglutide, which belong to a different diabetes drug class. Medical societies responded with alarm to the president’s comments, and on 27 February, Colombia’s health minister, Gustavo Jaramillo, was forced to clarify that the insulin shortages were not related to people seeking to lose weight.

Advocates for diabetes patients lamented the shortages, telling news outlets that hospitalizations have resulted. Érika Montañez, director of Fundación Voces Diabetes Colombia, a patient advocacy group, commented in the newspaper El Tiempo that “logistical delays, a scarcity of raw materials post-pandemic, and regulatory obstacles” were the reasons behind the shortages.

INVIMA statement (Spanish)

Mexico and Brazil announce new convergence measures

Officials with Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS) traveled to Brazil and met with their counterparts there in late February, announcing several new measures intended to advance regulatory convergence between the countries.

In news releases issued 26 and 29 February, COFEPRIS said that its director Alejandro Svarch Pérez had met with the directors of the Brazilian Health Regulatory Agency (ANVISA) and of Brazil’s Immunobiological Technology Institute (Bio-Manguinhos). Bio-Manguinhos, part of the Oswaldo Cruz Foundation (FioCruz), Brazil’s public health research institute, is Latin America’s largest public maker of vaccines.

The Brazil and Mexico teams agreed to coordinate in several areas.

COFEPRIS said it would issue Good Manufacturing Practices (GMP) guidance to the new Bio-Manguinhos plant, in Santa Cruz, Brazil. It also pledged to promote clinical trials in Mexico and facilitate the “authorization and access to health supplies manufactured by Bio-Manguinhos in Mexico and the more than 20 countries that recognize the authorizations of [COFEPRIS].” The agencies also will cooperate on training through the Regional Health Regulation School, a COFEPRIS-led project, based in Mexico, that has the backing of the Pan American Health Organization. The school will offer a course on vaccine production led by experts with Brazil’s FioCruz, COFEPRIS said.

The Mexican agency described its new alliance with Brazil as a “milestone” tantamount to its other international alliances, namely its membership in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Medical Device Single Audit Program (MDSAP).

COFEPRIS Statement (Spanish)

COFEPRIS reports increased efficiency since 2019

COFEPRIS has seen gradual reductions in the gaps between processes initiated and processes completed, from 56% in 2019 to 30% in 2021 to 9% in 2022, according to a detailed report.

The agency used a database search to determine how many processes for medicines (including new authorization requests, modifications to existing authorizations and extensions) were initiated and resolved during each calendar year.

The agency also reported year-by-year increases in the overall number of processes pending, except for in 2020, when the COVID-19 pandemic stalled normal regulatory activity. The agency noted that its elimination of third-party facilitators or agents, which ended in 2021, helped improve efficiency, and that it sought to “reach levels of less than 90 days in 2024 for the most complex” processes, such as new drug registrations and modifications to registrations of higher-risk products.

The agency described additional measures it has recently adopted or seeks to adopt, including combining all requests pertaining to the same drug into a single “package” for evaluation; faster clearing of modifications classified as lower risk; changes to organizational measures to keep processes moving constantly throughout the calendar year to avoid seasonal slowdowns, and expediting appointments for minor and moderate modifications.

COFEPRIS report (Spanish)

Brazil’s ANVISA concludes device development pilot

In November 2023, Brazil’s ANVISA agency published a notice to medical device developers, inviting them to participate in a pilot project that amounted to a competition for devices in development with the potential to impact public health in Brazil. The agency asked the firms to submit information on “a new technology or new application of an existing technology that could lead to clinical improvement, treatment, monitoring, cure, mitigation or prevention of [serious] illness” and potentially change health services protocols.

The agency said that it hoped the project, which would select 10 devices from among the submissions, would improve regulatory support for the selected developers, accelerate development of innovative devices, and promote collaboration between the agency and industry. On 27 February ANVISA published the results of the project, listing the acronyms or code names for 10 devices it had selected from among the submissions, but not providing details as to their developers, their uses, or why they were selected.

ANVISA statement (Portuguese)

Latin America Roundup: Colombia confronts insulin shortage

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