Latin America Roundup: Colombia’s INVIMA faces criticism amid HIV drug shortages, personnel shakeup

Concerns about a lack of leadership at Colombia’s National Institute for Drug and Food Surveillance (INVIMA) continue to intensify following an alert about shortages of pediatric HIV drugs. Meanwhile, INVIMA’s latest acting director has initiated a personnel shakeup, the country’s newspaper of record issued a scathing editorial about the agency, and union leaders have become increasingly vocal about their concerns.

On 20 January, El Espectador published an editorial decrying what it called “abandonment” at INVIMA. A “lack of clear direction” has “generated anguish among patients and health professionals,” the paper’s editorial board wrote. Citing the decision by recent INVIMA director-nominee Germán Velásquez to withdraw from the confirmation process last month after claiming that nothing had been done to advance his appointment, the newspaper questioned whether, if matters at the top had been handled so poorly, “what can we expect from the [daily] work of the institute? How can we tell patients not to worry?”

In an interview 10 days earlier with Colombia’s W Radio, Mira Anaya, a spokeswoman for Sintrainvima, an INVIMA workers’ union, argued that without a confirmed director, the agency would struggle to complete the crucial task of working through a years-long backlog comprising tens of thousands of approvals, renewals, and other procedures for medicines, devices and clinical trials. “Clearing all these procedures is not something that can be done from one day to the next,” Anaya commented. “We need an improved technological platform, and that implies decisions and budgeting.”

Colombia’s Health Minister Guillermo Jaramillo, in an interview with Caracol Radio on 17 January, brushed off concerns about INVIMA’s lack of leadership and blamed Colombia’s two previous presidential administrations for its ongoing problems. He also claimed that the agency has remained functional under its acting directors – some of whom have lasted as little as two months – and that a major overhaul was already underway.

According to a report in Semana, INVIMA Acting Director Adriana Pereira, in place since late December, demanded the written resignations of top agency personnel as of 4 January, in an act that could complicate the job of a future permanent director at the agency.

The implications of INVIMA’s problems once again became clear on 17 January, when the agency, which is charged with monitoring to prevent shortages of essential medications, disclosed inadequate supplies of two drugs used to treat pediatric HIV patients and unavailability of a third, nevirapine. The El Espectador editorial characterized the shortages as “a scandal,” and further evidence of a crisis at INVIMA.

Ministry of Health shortage notice (Spanish)

Mexico COFEPRIS’s expects digital platform will speed trial registrations by 75%

On 18 January, Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS) announced that its digital platform for clinical trials and studies, Digipris, is no longer requiring in-person meetings or physical paperwork, and that a 75% reduction in usual wait times can be expected with the program. The digital program, the agency said in a news release, “is strategic for attracting investments in research and the medical industry,” and “changes the historical dynamic between the user and the regulatory institution.”

In a separate announcement 15 January, the agency said it had authorized more than 200 products – including 27 medications and 181 devices – in the final weeks of 2023, as well as seven clinical trials, including one of an HIV treatment. The agency, which last year grappled with drug shortages exacerbated by its total shutdown of the country’s largest manufacturer of generic psychiatric medicines, has since been updating on its latest attempts to speed approvals, streamline procedures, and help ensure adequate supplies of medications in a country long beset by shortages. In the same 15 January announcement, COFEPRIS said it had launched a pilot program to prioritize controlled psychiatric medications and had resolved some 137 pending procedures related to these drugs.

COFEPRIS statement 1, 2 (Spanish)

Paraguay regulators warn about unregistered dengue vaccine

Regulators in Paraguay are warning that a product packaged as Takeda’s dengue vaccine, Qdenga, is being sold in pharmacies despite lacking marketing approval in Paraguay. Qdenga was approved last year by regulators in neighboring in Argentina and Brazil. In an alert issued on 19 January, Paraguay’s National Direction of Sanitary Vigilance (DINAVISA) urged citizens not to sell or purchase the product, and to report any evidence of its commercialization to the agency.

DINAVISA alert (Spanish)

ANVISA authorizes Brazil-developed COVID-19 vaccine

A Brazil-developed, India-manufactured, recombinant COVID-19 vaccine has received full approval by the Brazilian Health Regulatory Agency (ANVISA) for use in people 12 and older, the agency said on 8 January. The vaccine, manufactured by India’s Serum Institute and marketed as Zalika by the Brazilian firm Zalika Farmacêutica, Is the sixth COVID-19 vaccine to be fully approved in Brazil. The monovalent vaccine was developed against early circulating strains of the SARS-CoV-2 virus, but it must be updated this year against Omicron XBB1.5 strain as a condition of its licensing, the agency said in a news release.

ANVISA (Portugese)

Argentina publishes new fee scheme; supplements see big hike

On 5 January Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) announced a new fee system that increases fees for dietary supplements and medical foods by 440%, according to an analysis by Pharmabiz. Fees nonetheless remain modest, at under $250 for a new product registration and less than $150 for a modification to an existing registration. The changes occur under the auspices of a broader decree covering a wide variety of fee categories.

ANMAT (Spanish)

Guatemala, El Salvador regulators announce cooperation agreement

The Guatemalan government announced on 12 January that the country’s medicines agency, the Department of Regulation and Control of Pharmaceutical and Related Products (DRCPFA) had entered into a cooperation agreement with its counterpart in El Salvador aimed at promoting technical exchange and harmonizing standards between the two Central American countries. “The exchange of knowledge and experiences will serve to strengthen and support the pharmaceutical industry, and help harmonize and unify criteria to the benefit of the Salvadoran and Guatemalan populations,” said Leslie Samayoa, Guatemala’s vice minister of health regulation, vigilance and control, in a news release about the agreement.

Statement (Spanish)

Latin America Roundup: Colombia’s INVIMA faces criticism amid HIV drug shortages, personnel shakeup

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