Latin America Roundup: Mexico’s COFEPRIS withdraws two obesity drugs over safety concerns

Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) has revoked the marketing authorizations for two weight-loss products containing the active ingredients d-norpseudoephedrine, thyroid hormone, atropine, and diazepam. The products, branded as Redotex and Redotex NF, have been associated with hundreds of reported adverse reactions including tachycardia, thyroid problems, valve dysfunction, cardiac rhythm disturbances, anxiety and insomnia, the agency said. In a statement 18 May, COFEPRIS blamed corruption by previous governments for keeping the products on the market despite their containing an active ingredient, d-norpseudoephedrine, which the regulator said has been banned in Mexico since 2008.

COFEPRIS (Spanish)

COFEPRIS trims managers in bid for greater transparency and efficiency

In a further move to demonstrate a more transparent era at COFEPRIS, which has long been plagued by accusations of corruption and opacity, the agency announced on 18 May that it would eliminate the role of one class of functionary, called managers, in the regulatory process, using a new service delivery model it calls “Optimized, Modernized, Organized and Satisfactory,” or SOMOS. In a news conference announcing the change, Mexico’s Secretary of Civil Service, Roberto Salcedo Aquino, described the rational for the move: “Users come to execute a procedure and we tell them: ‘It is approved, as long as it meets these requirements.’ Managers are not needed, because that represents an additional cost that we are transmitting to the citizens.”

COFEPRIS (Spanish)

Prosecutors investigate cyberattacks against Argentina’s ANMAT

Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) has released little information related to cyberattacks that disabled its website late April, while systems of another government agency, the National Agricultural Technology Institute (INAT) and that of a major pharmaceutical distributor, Farmalink, have since been hacked and disabled. ANMAT’s site is back online and updated, though officials have not said whether its vulnerabilities have been fixed, according to a news report by Clarín. Argentina’s Specialized Prosecutor Unit for the Investigation of Cybercrime (UFECI), an entity created in December 2022, is reportedly investigating the ANMAT hack.

Clarín (Spanish)

ANMAT hosts regulators from El Salvador and Bolivia

In May, ANMAT regulators welcomed delegations from El Salvador and Bolivia. A meeting on 4 May with representatives from Bolivia’s Ministry of Health and various sub-agencies had the aim “of exchanging experiences in the framework of the implementation of drug traceability policies in the neighboring country,” ANMAT said in a statement. On 11 May, ANMAT received a visit from officials with El Salvador’s National Directorate of Medicines (DNM). That meeting focused on “exploring future lines of joint work promoting bilateral forums on training, control, inspections, and drug registration. Both agencies also agreed to work on a memorandum of understanding to strengthen regulatory capacities, according to ANMAT.

ANMAT (Spanish)

INVIMA admits to delays, procedure backlog

Colombia’s National Institute for Drug and Food Surveillance (INVIMA) last month said that its backlog had reached nearly 4,000 requests for initial registrations and nearly 18,000 for other processes, such as “modifications of existing authorizations, pharmacological evaluations, requests to exclude some products from [taxation], the approval of research protocols, and authorization of manufacturing licenses for cannabis derivatives,” according to El País.

INVIMA’s acknowledgement, confirming figures close to what outside observers had estimated, came as a response to an information request by the Spanish newspaper. “INVIMA has been developing a contingency plan to carry out the evaluation of all the procedures that it has pending to date,” the agency said in its communication to the newspaper. The regulatory agency is currently under investigation by Colombia’s Attorney General for its role in contributing to widespread medication shortages, particularly in government-subsidized hospitals and pharmacies. Its former director, Francisco Rossi, stepped down in March after public comments downplaying the problem.

El País (Spanish)

Brazil makes sweeping updates to clinical testing rules

Earlier this month, Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) approved a resolution that greatly expanded rapid clinical testing at the country’s pharmacies, allowing them to conduct nearly 50 tests on site, when previously they were authorized to conduct only glucose and COVID-19 screening. The new regulation, which updates a rule published in 2005, also describes extensive changes to technical, data handling, privacy and safety requirements for all types of tissue testing facilities, including traditional collection centers and clinical and pathology labs. Facilities will have until November 10 to comply.

Statement, Resolution (Portuguese)

Latin America Roundup: Mexico’s COFEPRIS withdraws two obesity drugs over safety concerns

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