VITOR HUGO BATISTASÃO PAULO, SP (FOLHAPRESS) - The Chamber of Deputies will hold a public hearing to discuss Paraguayan weight-loss pens, sold as versions of tirzepatide, and Anvisa's (National Health Surveillance Agency) restrictions on these medications. The request, approved on Wednesday (12), was presented by federal deputies Fausto Pinato (União-SP) and Diego Garcia (União-PR).
Chamber will hold public hearing to discuss Anvisa restrictions on Paraguayan pens
VITOR HUGO BATISTASÃO PAULO, SP (FOLHAPRESS) - The Chamber of Deputies will hold a public hearing to discuss Paraguayan weight-loss pens, sold as versions of tirzepatide, and Anvisa's (National Health Surveillance Agency) restrictions on...
The date of the hearing has not yet been set, but it is expected to take place within the next two weeks, according to Pinato's office. The debate will be promoted jointly by the Health and Science, Technology and Innovation committees.
- The hearing takes place amid regulatory measures adopted by Anvisa in relation to tirzepatide medicines manufactured in Paraguay, approved in the neighboring country, but banned in Brazil.
- Interest in these alternatives grew as Mounjaro, manufactured by the pharmaceutical company Eli Lilly - whose active ingredient is tirzepatide and the only one authorized for sale in Brazil...
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The date of the hearing has not yet been set, but it is expected to take place within the next two weeks, according to Pinato's office. The debate will be promoted jointly by the Health and Science, Technology and Innovation committees.
The hearing takes place amid regulatory measures adopted by Anvisa in relation to tirzepatide medicines manufactured in Paraguay, approved in the neighboring country, but banned in Brazil.
Interest in these alternatives grew as Mounjaro, manufactured by the pharmaceutical company Eli Lilly - whose active ingredient is tirzepatide and the only one authorized for sale in Brazil - became popular in the country as a treatment for obesity, but remained at a high price. A 2.5mg box costs around R$1,422, while a 15mg box costs R$3,499.
The request states that Anvisa's restrictions raised discussions about health security, access to treatments, pharmaceutical innovation and the agency's regulatory competence.
The Chamber document also mentions the study conducted by researchers from Unicamp (State University of Campinas) at the request of Folha de S.Paulo. The results showed that samples of Tirzedral, Tirzec, Lipoless, TG and Gluconex had an active ingredient equivalent to Mounjaro.
The text highlights, however, that the research did not evaluate characteristics such as sterility, stability or clinical safety. But for deputies, the results of the study reinforce the need to deepen the scientific and regulatory discussion on the topic, especially in light of Anvisa's public statements on the criteria necessary to prove the quality, safety and effectiveness of these medicines.
The deputies also claim that Anvisa did not present, in response to information requests sent by the Chamber, requested technical documents, such as laboratory reports, scientific studies and opinions that would have supported the publication of resolutions related to the topic.
"Holding the public hearing will bring together different institutions and experts to clarify the scientific, regulatory and legal aspects involved", says the request.
Among the expected guests are the director-president of the National Health Surveillance Agency (Anvisa), Leandro Safatle; a representative from CIATox (Unicamp Toxicological Information and Assistance Center); the spokesperson for the Brazilian Association for the Support of Obese and Bariatric People, Jorge Bentes, owner of the Instagram profile "I'm tired of being fat"; and doctor Tassyane Boel, a specialist in obesity and diabetes.
Lawyers André Schleich and Priscilla Ruschel, who work on cases related to tirzepatide, were also nominated.
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