Latin America Roundup: Colombia’s top regulator quits after 6 months; was key champion of multi-country agency

Francisco Rossi, director of Colombia’s National Food and Drug Surveillance Institute (INVIMA) since September 2022, is leaving the agency and will be replaced by Mariela Pardo Corredor, the Colombia Ministry of Health and Social Protection announced on 23 March.

Rossi’s departure comes amid heated legislative debates about ongoing medication shortages in the country and the role of the regulatory agency in addressing them. Rossi had been a top proponent, along with his counterparts in Cuba and Mexico, of a proposed multi-country regulatory body in Latin America and the Caribbean, modeled after the European Medicines Agency, plans for which were advancing at the time of the announcement. On 17 March, just days before Rossi’s departure, INVIMA issued a statement [in Spanish] promoting the initiative, which “seeks to strengthen health capacities and support the authorization process for medicines and vaccines in health emergencies, contributing to the region’s health self-sufficiency,” the agency said.

Ministry of Health release (Spanish)

Mexico physician’s groups clash with president over fentanyl

In recent months Mexican and US officials have held high-level discussions over how to prevent illegal fentanyl, a synthetic opioid, from entering the US. In mid-March, Mexican President Andres Manuel Lopez Obrador proposed a ban on the legal, medicinal use of fentanyl in both countries, suggesting that other analgesics be substituted.

On 21 March, some 50 Mexican physicians’ groups and healthcare organizations signed on to a statement affirming their “total rejection” of the proposed ban. The statement noted that medical fentanyl is used in some 95% of surgeries in Mexico; that it is a superior analgesic for major surgeries available at relatively low cost and that it is used across a range of specialties including surgery and oncology. The Mexican government routinely makes bulk purchases of the analgesic, and experts say little medical fentanyl is diverted to illicit use in Mexico. Rather, illicit fentanyl is produced in clandestine Mexican labs using precursor chemicals imported from China and other countries. Mexican President Lopez Obrador has repeatedly denied that illegal fentanyl is produced in bulk in Mexico, despite frequent large-scale seizures of it by authorities on both sides of the border.

Physicians’ groups statement (Spanish)

COFEPRIS firings said to be fentanyl-related

Mexican President Lopez Obrador acknowledged that former employees of Mexico’s medicines agency were being investigated for suspicious importations related to fentanyl and that Mexican drug cartels had placed people inside the agency to facilitate imports, in comments made at a news conference on 24 March and reported by the Associated Press.

The Federal Commission for Protection against Health Risks (COFEPRIS) has found itself at the center of dramatic probes and purges in recent years. In June 2021, the Mexican president took the remarkable step of having Mexican Navy officials temporarily take over the COFEPRIS offices. Afterward some 32 agency employees were reportedly fired, some for alleged offenses involving fentanyl or precursor chemicals.

Last November the head of COFEPRIS, Alejandro Svartch, announced the creation of a tracking system, used in collaboration with the Mexican Navy, for chemicals that have legal applications but can also be used in making synthetic drugs such as methamphetamine and fentanyl. In February of this year the Mexican government announced that some 11 more COFEPRIS employees had been fired; the president has in recent days insinuated that certain of those firings were fentanyl-related.

Associated Press

Argentina’s ANMAT Signs MOU with USP

Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) and the US Pharmacopeia have signed a memorandum of understanding n an effort “to strengthen the relationship of trust that both organizations have maintained for several years, as well as to promote the exchange of knowledge,” Argentina’s government announced 16 March. The memorandum followed a two-day meeting in Argentina between officials with ANMAT and USP, including USP Chief Executive Officer Ronald T. Piervincenzi. The MOU deals with “exchange of technical and scientific assistance, sharing experience and information, and promoting cooperation in efforts to establish standards … to promote the quality of medicines,” according to the government statement.
Argentina statement (Spanish)

Mexican regulators give nod to tesofensine for weight loss

Tesofensine, a novel oral monoamine uptake inhibitor that works to reduce appetite, received a favorable opinion last month from COFEPRIS’s committee for new molecules for the treatment of obesity. According to a statementrelease from the Danish biotech firm Saniona, the Mexican company Medix licensed the rights to develop and commercialize tesofensine in Mexico and Argentina in 2016. After a successful Phase 3 trial in Mexico in adults with obesity, Medix filed for marketing authorization in December 2019. Need for anti-obesity treatments is strong in Mexico, where obesity is a leading public health concern affecting more than a third of adults, according to a Mexican study published in The Lancet.

The committee’s favorable opinion is not tantamount to marketing authorization, and further steps are needed before tesofensine can be approved, Saniona said in its news release.

Approval in Mexico is expected before the end of the year, the company’s CEO expressed to a Scandinavian news outlet, and may trigger approval of tesofensine in other Latin American countries using the Mexican agency as a reference.

Outside Latin America, the company is aiming at narrower indications, developing tesofensine in combination with metoprolol, a beta blocker, for the treatment of Prader-Willi syndrome and hypothalamic obesity. In 2021 the US Food and Drug Administration granted the combined therapy an orphan drug designation, first for PWS and months later for hypothalamic obesity. Studies are underway to support authorization for these indications in the US and EU.

Tesofensine was first developed as a treatment for Alzheimer’s disease and Parkinson’s disease, for which it failed in early trials. Because weight loss was frequently reported as a side effect, it was later developed as an obesity treatment.

Statement

Takeda dengue vaccine approved for pediatric, adult use in Brazil

The Japanese drugmaker Takeda announced 13 March 13 that its dengue vaccine, marketed as QDENDGA, had been approved by Brazil’s National Health Surveillance Agency (ANVISA) “for the prevention of dengue caused by any of the four virus serotypes that can be found in individuals from 4 to 60 years of age.” It may be used, the company said, without the need for pre-vaccination testing and regardless of previous exposure. The approval is the first for a dengue vaccine in Latin America and is supported, Takeda said, by results from 19 Phase 1, 2, and 3 clinical trials enrolling some 28,000 children and adults.

News release

Latin America Roundup: Colombia’s top regulator quits after 6 months; was key champion of multi-country agency

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