RESUMO
This article reviews the regulatory, social, policy, and other issues that will shape the development of pharmacogenomics applications. We identify and analyze 19 key public policy issues, ranging from the economic incentives for linked diagnostic-drug development, to the regulation of tests and drugs, and to privacy and informed consent. Challenging technical, business, and policy-related issues might either hinder progress in the field of pharmacogenomics or potentially accelerate it, depending on how they are addressed and resolved. How well the numerous important stakeholders - both private and public - address these issues will be critical for pharmacogenomics to deliver on its promise.
Assuntos
Desenho de Fármacos , Testes Genéticos/legislação & jurisprudência , Regulamentação Governamental , Marketing de Serviços de Saúde/legislação & jurisprudência , Farmacogenética/legislação & jurisprudência , Política Pública , Qualidade de Produtos para o Consumidor , Aprovação de Drogas , Custos de Medicamentos , Determinismo Genético , Privacidade Genética/legislação & jurisprudência , Testes Genéticos/economia , Humanos , Consentimento Livre e Esclarecido , Reembolso de Seguro de Saúde , Marketing de Serviços de Saúde/economia , Farmacogenética/economia , Estados UnidosRESUMO
To many, genomics is merely exploitable technology for the leviathan of biotechnology. This is both shallow and short sighted. Genomics is applied knowledge based on profound and evolving science about how living things develop, how healthy or sick we are, and what our future will be like. In health care, genomics technologies are disruptive yet potentially cost-effective because they enable primary prevention, the antidote to runaway costs and declining productivity. The challenges to integration are great, however, and many bioethical and social-policy implications are alarming. Because it is poorly understood today, we must debate genomics vigorously if we are to act wisely. Public policy must lead.
Assuntos
Genômica/legislação & jurisprudência , Política Pública , Centers for Medicare and Medicaid Services, U.S. , Atenção à Saúde/economia , Genômica/organização & administração , Humanos , Programas de Assistência Gerenciada , Formulação de Políticas , Garantia da Qualidade dos Cuidados de Saúde , Estados UnidosRESUMO
The Food and Drug Administration (FDA) approval of BiDil unleashed a vigorous commentary, mostly critical of the decision. The FDA was soon caught between biologists, who see research and clinical utility in using racial classifications, and social scientists (and many politicians), who fear the adversities of greater discrimination. Analyses rarely addressed the practical factors the FDA had to consider in reaching a decision. Much of the literature simply assigned the question to the domain of racial politics, failing to consider the ethics of professional care, the Hippocratic oath, and the marketplace efficiency in moving drugs quickly to those who might most benefit.
