Latin American Roundup: Regulators announce new training, convergence initiatives after Washington meeting

Representatives of Pan American Health Organization-designated national regulatory agencies of regional reference in Latin America and the Caribbean, along with officials from the US Food and Drug Administration (FDA) and Health Canada, met for two days last week in Washington, DC to address regulatory gaps in the Americas.

At the semi-annual meeting, the agencies also on explored a roadmap for the transition of national agencies of reference to WHO listed authorities (WLA) status, which indicates more stringency in assessing quality, safety and efficacy data, and in inspections of clinical trial and manufacturing sites. According to PAHO, regulators from Chile, Cuba, Colombia, Mexico, Argentina and Brazil participated.

PAHO meeting announcement, statement (Spanish)

Mexico, Brazil eye greater convergence

During the two-day meeting in Washington, DC, Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS) met with Brazilian regulators “to design a work plan aimed at regulatory convergence and the recognition of inspection visit records and good practice certificates.” The effort, conducted under the auspices of the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) seeks to “to carry out joint verification visits to standardize the surveillance processes to ensure that safe and effective health supplies are available” in both countries. COFEPRIS described the agreement with Brazil as a step that would advance harmonization of legal frameworks according to “the highest international standards.”

An additional area of focus involved strengthening human resources in regulatory affairs. On 13 July, COFEPRIS announced a plan for a Regional School of Health Regulation (Escuela Regional de Regulación Sanitaria). “This initiative by Mexico will allow us to have coordinated and vigorous educational programs [and] maximize the use of resources and efforts,” commented agency head Alejandro Svarch. The school, Svarch added, will “promote the updating of regulatory frameworks to improve convergence and initiate the adoption of international standards.”

Statement (Spanish)

Colombia’s INVIMA claims backlog is clearing; industry doubts figures

Colombia’s National Food and Drug Surveillance Institute (INVIMA) announced on 11 July that it had cleared over 10,000 processes – among them new licenses, renewals, certifications and authorizations – from its backlog in the first half of 2023. The agency’s assertion was immediately challenged by industry groups, which demanded to see specifics and suggested that these represented mostly automatic renewals. One trade entity, the Colombian American Chamber of Commerce, expressed to Colombian news outlets that “advances in the clearing of procedures are not being reflected and, on the contrary, concern persists over the administrative times that directly affect the supply of medicines, legal certainty and the innovative development of the industries that require permanent and agile support” from the agency. INVIMA responded with a statement insisting that it rejected the insinuations and that the figures it cited were supported by evidence.

Statement (Spanish)

INVIMA bureaucrat accused in black market cancer drug case

Colombian prosecutors have accused a former INVIMA official of collaborating with a ring that sold black market medications, many of them high-cost cancer drugs, to hospitals in the cities of Bogotá and Barranquilla.

The investigation has centered on one businesswoman, Dianna Carolina Bernal Ferro, whose Colombia-based firm, Pharmaceuticals Supply, claimed to provide “all the procedures and logistics necessary for the delivery of medicines nationwide,” and who is accused of bribing INVIMA officials. Physicians and insurance company personnel were among the 13 individuals allegedly involved in the scheme, which moved the medicines from Venezuela into Colombia for delivery through selected insurers.

The one INVIMA official named in the case, Sergio Fabián Ramírez, was employed by the agency through April 2023, prosecutors said. Ramirez, they claimed, influenced other INVIMA staff on behalf of the criminal ring. INVIMA assisted prosecutors in the investigation, which arose following a complaint from a Colombian oncology drugs manufacturer.

Though the drugs sold by the ring were trafficked into Colombia from Venezuela, most were manufactured in the U.S., India and China. Some 800 kilograms of the products were confiscated in the operation. It is unclear whether the medications were adulterated, as some reports claimed, or their documentation was falsified regarding dates, cold chain storage and other data.

Statement (Spanish)

Brazil may allow ‘skinny labeling’ for generics

Though Brazilian law currently mandates that generic medicines maintain the same labeling as their branded equivalents, and prohibits any carve-outs, the Brazilian medicines agency ANVISA is weighing whether to change this.

So-called skinny labeling allows a generic manufacturer to seek regulatory approval for specific indications while excluding other patented uses by the equivalent brand-name drug, thereby avoiding patent disputes, speeding entry to market, and potentially improving access.

In late 2022, ANVISA solicited comment on a proposed rule change to allow carve-outs. Healthcare sector analyst Benny Spiewak, an intellectual property attorney in Sao Paolo, reported in a July 5 column in Lexology that the resulting comments came mostly from industry. “In brief, generic players want the change. Innovators are not so sure.”

ANVISA’s assessment is expected soon, Spiewak wrote, arguing that the proposed rule change could have profound effects not just on Brazil’s regulatory environment, but its free-speech laws as well, as manufacturers seek to limit the encouragement of generic drug use for indications still covered by patents. It is unclear, he added, whether ANVISA would require the recall of generic products with outdated labels and how skinny labels might affect current Brazilian guidelines on the patentability of incremental uses.

Lexology (English)

Bolivia pulls licensing for immunoglobulin product

Regulators with Bolivia’s State Agency for Medicines and Health Technologies (AGEMED) said on 12 July that they had pulled an immunoglobulin product from the market after reports of adverse effects in children.

Days earlier, a Bolivian legislator, Rodrigo Valdivia, had denounced AGEMED for having kept on the market the Indian-made product, marketed as Immuglo, for months after it was pulled by Brazilian regulators last year. The medication, said, contributed to adverse effects among children treated in a hospital in the city of Cochabamba.

“How is it possible that AGEMED has allowed a drug that prohibited in other countries to enter our country? There are already several countries that have shown that this generates adverse effects when given to children who have immunodeficiency,” Valdivia, a representative from Cochabamba, complained to the Bolivian news organization ANF.

The product, marketed as Immuglo, was licensed in Bolivia in August 2022. It was suspended by Brazilian regulators in December of that year following tests in different lots that revealed contaminants that, ANVISA said, could cause fever, chills, vomiting and tremors.

Agencia de Noticias Fides (Spanish)

Latin American Roundup: Regulators announce new training, convergence initiatives after Washington meeting

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