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Boletín Fármacos: Agencias Reguladoras Y Políticas

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Boletín Fármacos: Agencias Reguladoras Y Políticas Boletín Fármacos: Agencias Reguladoras y Políticas Boletín electrónico para fomentar el acceso y el uso adecuado de medicamentos http://www.saludyfarmacos.org/boletin-farmacos/ Volumen 24, número 2, mayo 2021 Boletín Fármacos es un boletín electrónico de la organización Salud y Fármacos que se publica cuatro veces al año: el último día de cada uno de los siguientes meses: febrero, mayo, agosto y noviembre. Editores Núria Homedes Beguer, EE.UU. Antonio Ugalde, EE.UU. Editores Asociados Corina Bontempo Duca de Freitas, Brasil Albin Chaves, Costa Rica Asesor en Regulación Hernán Collado, Costa Rica Ricardo Martínez, Argentina Francisco Debesa García, Cuba Anahí Dresser, México José Humberto Duque, Colombia Asesor en Políticas Albert Figueras, España Eduardo Espinoza, El Salvador Sergio Gonorazky, Argentina Federico Tobar, Panamá Alejandro Goyret, Uruguay Eduardo Hernández, México Luis Justo, Argentina Corresponsales Óscar Lanza, Bolivia Rafaela Sierra, Centro América René Leyva, México Steven Orozco Arcila, Colombia Duilio Fuentes, Perú Raquel Abrantes, Brasil Benito Marchand, Ecuador Gabriela Minaya, Perú Bruno Schlemper Junior, Brasil Webmaster Xavier Seuba, España People Walking Federico Tobar, Panamá Francisco Rossi, Colombia Equipo de Traductores Núria Homedes, EE UU Enrique Muñoz Soler, España Antonio Ugalde, EE UU María Cristina Latorre, Colombia Andrea Carolina Reyes Rojas, Colombia Boletín Fármacos solicita comunicaciones, noticias, y artículos de investigación sobre cualquier tema relacionado con el acceso y uso de medicamentos; incluyendo temas de farmacovigilancia; políticas de medicamentos; ensayos clínicos; ética y medicamentos; dispensación y farmacia; comportamiento de la industria; prácticas recomendables y prácticas cuestionadas de uso y promoción de medicamentos. También publica noticias sobre congresos y talleres que se vayan a celebrar o se hayan celebrado sobre el uso adecuado de medicamentos. Boletín Fármacos incluye una sección en la que se presentan síntesis de artículos publicados sobre estos temas y una sección bibliográfica de libros. Los materiales que se envíen para publicarse en uno de los números deben ser recibidos con treinta días de anticipación a su publicación. El envío debe hacerse preferiblemente por correo electrónico, a ser posible en Word o en RTF, a Núria Homedes ([email protected]). Para la revisión de libros enviar un ejemplar a Antonio Ugalde, 1808 Gelncliff Dr Austin Tx 78704, EE.UU. Teléfono: (202) 9999076 Índice Boletín Fármacos: Agencias Reguladoras y Políticas 2021; 24 (2) Agencias Reguladoras Entrevistas Las agencias del medicamento son una invención del capitalismo neoliberal de los años noventa Mar Calpena 1 Regulación Internacional Características de los placebos Salud y Fármacos 3 El nuevo código de Farmaindustria Salud y Fármacos 4 Colaboración entre la EMA y Health Canada Salud y Fármacos 4 EMA y Health Canada publican los datos clínicos que respaldan las autorizaciones de la vacuna Covid-19 Moderna EMA, 2 de marzo de 2021 5 La regulación y cobertura de los productos oncológicos en Canadá, Inglaterra y EE UU Salud y Fármacos 6 América Latina Utilización de decisiones de autoridades regulatorias de otras jurisdicciones para aprobar nuevos productos medicinales en países de América Latina y el Caribe Durán, CE et al 7 El reto de la investigación clínica en México Maribel Ramírez Coronel 8 Perú. Proyecto para regulación de precios de medicamentos vuelve a Comisión de Salud Congreso Noticias, 18 de marzo de 2021 9 Europa Información de daños en los informes de estudios clínicos oncológicos presentados a la Agencia Europea de Medicamentos en comparación con registros y publicaciones de ensayos: una revisión metodológica Paludan-Müller AS, Créquit P, Boutron I. 10 Filtraciones de la EMA sobre una vacuna Covid-19: ataques, presiones regulatorias y preocupaciones de fabricación Patnaik P, Hordijk L 10 La EMA manejó mal una investigación sobre presuntos daños neurológicos graves de las vacunas contra el VPH Gøtzsche PC, Jørgensen KJ. 15 Acuerdo entre Merck y los reguladores antimonopolio austriacos por el elevado precio de un medicamento contra el cáncer Salud y Fármacos 19 España. Adecuación de la seguridad del metamizol y agranulocitosis García del Campo C, Murcia Soler M, Martínez-Mirc I, Palop Larrea V 20 La jurisdicción administrativa suprema de Francia confirma la importancia de abolir las marcas paraguas Rev Prescrire 2020; 40 (436): 148 20 EE UU y Canadá Oír sin escuchar: Durante la audiencia de la FDA, el presidente interino interrumpió las preguntas y limitó el debate. David S. Hilzenrath 21 Covid-19. Los esfuerzos del gobierno aceleran la elaboración de vacunas y tratamientos, pero se necesita más transparencia en las autorizaciones de uso de emergencia. GAO-21-207 24 Woodcock: las farmacéuticas y los reguladores tienen algo que aprender del Covid Kari Oakes 26 Características de velocidad, evidencia y seguridad para que la FDA apruebe las vacunas Puthumana J, Egilman AC, Zhang AD et al. 27 Un estudio analiza los 20 años que la FDA ha estado aprobando opioides con escasos datos de seguridad Dustin Manduffie 28 La guía de la FDA para las aprobaciones para uno en emergencia de las vacunas Covid Salud y Fármacos 29 Actualización sobre el coronavirus (Covid-19): La FDA publica políticas para guiar a los desarrolladores de productos médicos que están abordando variantes del virus FDA 30 Mejorar el acceso a las inspecciones de la FDA Salud y Fármacos 32 Oncología: La FDA y la aceptación de medidas indirectas de impacto Salud y Fármacos 32 Keytruda de Merck pierde la autorización para el cáncer de pulmón de células pequeñas y la FDA reevalúa aprobaciones aceleradas otorgadas Mark Terry 33 La administración Trump, la pandemia y la FDA Salud y Fármacos 34 La FDA y la evaluación de la vacuna de Pfizer Salud y Fármacos 38 Problemas en la planta de Merck para producir la vacuna Covid 19 de J&J e indiferencia de la FDA Salud y Fármacos 39 Becerra debe tomar medidas inmediatas para abordar la colaboración inapropiada entre la FDA y Biogen por el producto para el Alzheimer Public Citizen 40 Diversidad en los ensayos clínicos: la FDA impulsa los ensayos con datos de la práctica clínica y un mayor número de centros de investigación Mary Ellen Schneider 40 La FDA debe rechazar el tanezumab para tratar la osteoartritis por sus peligros inaceptables, poco o ningún beneficio Public Citizen 41 África ¿Por qué se necesita una Agencia Africana de Medicamentos? ¡Ahora más que nunca! Safeeyah Kharsany 43 Políticas Entrevistas Así como tuvimos drogas genéricas podríamos tener vacunas genéricas Pablo Correa 44 Gerald Posner: "Le dimos la responsabilidad de salvarnos como civilización a la industria farmacéutica" Jorge Fontevecchia 46 Políticas Internacionales Minimizando el doble estándar Ruth Macklin 47 Covid-19: el desafío de acceder a las tecnologías en el mundo globalizado Bermudez L, Bermudez J 50 Las grandes farmacéuticas se lo llevan todo. Cómo las corporaciones farmacéuticas se benefician de sus privilegios, incluso en una crisis de salud global como Covid-19 Public Eye Report, 54 Entre la ética, la salud y la economía Germán Velásquez 56 El nacionalismo de las vacunas es claramente injusto. Los países pobres están pagando más por las dosis que les sobran a los países ricos Nanjala Nyabola 58 Covid-19 nos enseña, pero ¿aprenderemos? Mohga Kamal-Yanni 60 Los inversionistas buscan soluciones a la pandemia Salud y Fármacos 62 El juego diplomático por las vacunas contra la Covid-19 Mujib Mashal, Vivian Yee 63 América Latina Las vacunas como bien público global y cuestión de soberanía sanitaria regional CLASO 64 América Latina - ¿Deben los mercados emergentes fabricar productos farmacéuticos frente a la pandemia? Subir K. Basak 66 Gobiernos de América Latina otorgaron beneficios legales y tributarios a farmacéuticas en compra de vacunas Iván Ruiz, Romina Colman, Claudia Ocaranza, Claudia Chávez 67 Brasil necesita vacunas. China se beneficia Ernesto Londoño, Leticia Casado 67 Juez brasileño suspende las extensiones de patentes de fármacos, decisión podría bajar costo tratamiento Covid-19 Ricardo Brito 69 Colombia – Dependencia farmacéutica Gabriel Cifuentes Ghidini 70 Colombia - Proyecto de ley busca que haya una mayor seguridad farmacéutica en Colombia Cristian Acosta Argote 71 México - El abandono deliberado de Birmex y la salud Luis Herrera 72 Vacuna nacional, sin apoyo oficial Felipe Cobián Rosales 73 Paraguay. Fijación de precios de medicamentos en tiempos de pandemia. Urgente y necesario Cynthia Andino 75 Europa Precios de los medicamentos: los países europeos unen fuerzas Revue Prescrire 2020; 40(438)305-6 76 Liberar patentes: la no solución para aumentar la fabricación de vacunas Covid-19 Mónica Gail 77 EE UU y Canadá Biolyse sugiere que Health Canada no considera urgente su solicitud de producir vacunas Covid-19 para exportar Jacquelyn LeBel 78 Canadá: Biofarmacéuticas, financiarización y nacionalismo en la era del Covid-19 Matthew Herder 79 Política de medicamentos de venta con receta: El año transcurrido y el año próximo Rachel Sachs 82 El gran cambio de Howard Dean Salud y Fármacos 86 Carta: Biden debería utilizar la tecnología patentada por el gobierno de EE UU para ampliar la producción de la vacuna del NIH-Moderna. EE UU puede ayudar a poner fin a la pandemia si aprovecha su poder sobre la patente de la vacuna Public Citizen 87 Trump hizo una concesión de último minuto a las compañías farmacéuticas sobre los precios de los medicamentos de venta con receta. Los demócratas
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