ANVISA: Após publicação de decreto legislativo, Dirceu Barbano afirma que vai tentar restringir a venda de emagrecedores

Da Redação

Com a publicação, no último dia 05, do Decreto Legislativo 273/2014, que suspende a resolução da Agência Nacional de Vigilância Sanitária (Anvisa) que havia proibido a venda e produção dos emagrecedores Mazindol, Anfepramona e Femproporex, o diretor-presidente da Anvisa, Dirceu Barbano, afirmou: “Vivemos um vácuo normativo”. Na próxima reunião de diretoria da agência, Barbano vai propor novas regras para tentar restringir a venda dessas três substâncias. A indústria teria de apresentar, para obter ou renovar registro dos medicamentos, estudos demonstrando a eficácia e segurança das drogas.

Outra medida proposta é proibir que o medicamento seja preparado em farmácias de manipulação. Barbano mais uma vez criticou a decisão, do Congresso, de liberar a venda dos medicamentos.“ Foi uma decisão irresponsável e perigosa. Não sei quem ganhou com isso”, afirmou. Ele não sabe, no entanto, a opinião de seus colegas de colegiado sobre o tema.

A liberação sacramentada nesta sexta, no entanto, tem eficácia limitada. “Os pacientes não vão encontrar o medicamento industrializado na farmácia de uma hora para outra”, afirmou o presidente do Sindicato da Indústria de Produtos Farmacêuticos do Estado de São Paulo (Sindusfarma), Nelson Mussolini.

O presidente destacou que a retomada da produção ainda exige uma adaptação das empresas. E completou que, por enquanto, nenhuma das fabricantes consultadas decidiu se vai retomar a atividade. “Das três empresas que produziam os remédios, uma já afirmou que não irá retomar a atividade. Outras duas não manifestaram entusiasmo, diante da eventual necessidade da realização de testes de eficácia e segurança. São testes caros”, contou.

Para farmácias de manipulação, completou, a retomada é mais fácil. “Basta ter a matéria-prima autorizada para o uso”, disse. A mesma resolução que proibiu a venda de Mazindol, Anfepramona e Femproporex, de 2011, trouxe regras mais rígidas para a venda de outro remédio usado no tratamento da obesidade, a Sibutramina. Tais regras caíram com o decreto do Congresso Nacional. “Para esses medicamentos, agora é exigido apenas o receituário de via azul”, disse Mussolini. Barbano avisou que também vai propor a reedição de regras mais rígidas para Sibutramina.

A resolução da Anvisa foi aprovada em 2011, depois de audiências públicas que reuniram representantes de sociedades médicas e pesquisadores. A Anvisa avaliou que o remédio trazia mais riscos do que benefícios. Além disso, não havia estudos que demonstrassem a eficácia do medicamento. Desde que a proposta foi feita, no entanto, representantes de associações médicas e de pacientes criticaram a decisão, por considerá-la uma redução radical nas opções de tratamento.

Fontes: Assessoria do CRF-SP, O Estado de S. Paulo, Folha de Vitória e D.O.U

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