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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/ Publicado por Salud y Fármacos Volumen 23, número 1, Febrero 2020 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 José Ruben de Alcantara Bonfim, Brasil Francisco Debesa García, Cuba Anahí Dresser, México Asesor en Políticas José Humberto Duque, Colombia Marco Barboza, Perú 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 Roberto López Linares, Perú Benito Marchand, Ecuador Gabriela Minaya, Perú Webmaster Bruno Schlemper Junior, Brasil People Walking Xavier Seuba, España Federico Tobar, Panamá Francisco Rossi, Colombia Equipo de Traductores Núria Homedes, EE UU Enrique Muñoz Soler, España Antonio Ugalde, EE.UU. 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 2 Índice Boletín Fármacos: Agencias Reguladoras y Políticas 2020; 23 (1) Agencias Reguladoras Investigaciones Prescrire opina sobre las recomendaciones centrales del informe sumario del Grupo de Trabajo Conjunto HMA-EMA sobre Grandes Bases de Datos (Big Data) Prescrire 1 El uso de medidas de impacto indirectas validadas y no validadas en dos vías de aprobación aceleradas de la Agencia Europea de Medicamentos: un estudio transversal de productos autorizados 2011-2018 Bruce CS, Brhlikova P, Heath J, McGettigan P 2 Fracaso imprudente en la identificación de efectos adversos peligrosos en los nuevos medicamentos para la diabetes Worst Pills Best Pills Newsletter, diciembre de 2019 4 ¿Los expertos de los paneles asesores tienden a votar como rebaño? Evidencia de los comités de la FDA Newham M, Midjord R 4 Los Biosimilares en la UE. Guía informativa para profesionales sanitarios. Actualizada 2019 Elaborada conjuntamente por la Agencia Europea de Medicamentos y la Comisión Europea 5 Plan de medicamentos prioritarios de la Agencia Europea de Medicamentos a los dos años: una evaluación de estudios clínicos que respaldan los medicamentos elegibles 6 Evaluación de ensayos clínicos en Brasil: historia y actualidad Gouy CML, Porto TF, Penido C. 6 Regulación Internacional Acceso global a productos médicos de calidad garantizada: la Declaración de Oxford y el llamado a la acción 7 Involucrar a los pacientes en la regulación de medicamentos: la historia de dos agencias 10 Según un nuevo informe, para mejorar la salud pública, los reguladores de medicamentos de todo el mundo deberían colaborar y eliminar las barreras para compartir información 12 La colaboración entre diversas agencias reguladoras 13 Mejorar del acceso a la reparación a través de la cooperación internacional: consideraciones del instrumento jurídicamente vinculante sobre las empresas transnacionales y otras empresas comerciales 14 Las decisiones de la EMA y de la FDA pueden impactar negativamente en América Latina 14 IGBA pide una mayor convergencia regulatoria para los biosimilares 14 La FDA colabora con Health Canada y Australia para aprobar nuevos medicamentos oncológicos 16 Europa EMA advierte que sus esfuerzos por la transparencia de los ensayos clínicos podrían peligrar 16 Investigadores advierten que la ley europea de datos impide estudios sobre diabetes y Alzheimer 17 La EMA reconoce que se está quedando atrás ante el cambio de paradigma de la innovación 18 Evaluar el impacto ambiental de los medicamentos es financieramente 'catastrófico' para la industria farmacéutica 19 A las puertas de ESMO, un estudio cuestiona la credibilidad de la evidencia de los ensayos 20 La EMA adopta las recomendaciones del Defensor del Pueblo de la UE para evitar la preocupación por el sesgo en las aprobaciones de medicamentos 20 CE ofrece mayor claridad sobre la regulación de los ensayos clínicos 21 Comisión Europea explica lo que significa autorizar ensayos clínicos con condiciones 22 ¿Cuándo pueden los resultados de la práctica clínica traducirse en evidencia creíble? Los funcionarios de la EMA discuten 22 El marco legal y regulatorio para las farmacias comunitarias en la Región Europea de la OMS (2019) 23 Francia mantendrá esquemas de aprobación rápida de ensayos clínicos 23 El regulador del Reino Unido admite el uso no autorizado del oncológico Avastin para una afección ocular grave 24 EE UU y Canadá La decisión de Canadá de publicar más datos de ensayos clínicos presiona a la FDA 25 Los miembros de los paneles y comités asesores de la agencia reguladora canadiense y las declaraciones de conflictos de interés 27 Dificultades de la FDA para regular el medicamento a lo largo de su vida 29 Magnitud del efecto de los tratamientos aprobados por la FDA sin resultados de ensayos clínicos aleatorizados 31 La FDA está rompiendo el status quo de la ciencia reguladora 33 3 GAO: los fabricantes de medicamentos tienen opiniones diferentes sobre las acciones REMS de la FDA y FTC 34 ¿Qué efectos secundarios? Los problemas con los medicamentos podrían no informarse siempre a la FDA 36 ¿De nuevo? Doral, el medicamento contra el insomnio de Galt, recibe una segunda reprimenda de la policía de la FDA que vigila la promoción 37 La FDA advierte a la instalación china de análisis de medicamentos por rechazar la inspección 38 La FDA busca retirar 4 nuevas solicitudes de medicamentos porque las empresas no presentaron informes anuales 38 Totalmente inadecuada: Public Citizen tilda de lenta la respuesta de la FDA para garantizar opioides más seguros. La Agencia debe implementar las recomendaciones de las Academias Nacionales de 2017 39 GAO encuentra problemas continuos con las inspecciones de la FDA a las instalaciones extranjeras de medicamentos 40 Un nuevo estudio dice que algunos vendedores de suplementos para estimular el cerebro están incumpliendo una prohibición de la FDA 41 Para globalizar la protección de la salud pública ampliando las sanciones penales 42 ¿La FDA hace lo suficiente para sacar biosimilares al mercado? Los expertos discuten 44 Los líderes de la FDA temen que la agencia pierda talento en terapia génica y oncología 45 La FDA admite que se equivocó al otorgar la categoría de huérfano a un tratamiento de adicción a los opioides 46 La FDA mantiene los medicamentos de marca en el programa de revisión acelerada, a pesar de los problemas de fabricación 47 La FDA finaliza la guía sobre diseños de ensayos adaptativos 49 La FDA revisa la guía sobre estudios pos-comercialización para incluir el Sistema ARIA, la Ley SUPPORT 50 La FDA aclara cómo regulará la salud digital y la inteligencia artificial 50 Scott Gottlieb tiene otro puesto en una junta directiva para agregar al currículum, y es sobre un tema favorito 51 Políticas Investigaciones Recomendaciones de políticas para reducir los precios de medicamentos Public Citizen 52 Entrevistas Necesitamos una opción pública en la industria farmacéutica 55 Políticas Globales Integridad de la investigación: es el momento de tomar medidas globales 57 América Latina Chile. Piñera: No vamos a permitir que las farmacias sigan abusando de las personas 57 Colombia. Recobros por medicamentos le han costado al país Pco13.000 millones de pesos: Procuraduría 58 Colombia. El “regaño” del Consejo de Estado al Minsalud por expedir un polémico decreto 59 Perú. Medicinas baratas, accesibles y de calidad 60 Europa España. Los laboratorios proponen que la industria nacional produzca los fármacos que sufren desabastecimiento 61 Malta observa lo que hace Europa sobre la transparencia de los precios de los medicamentos 62 Países Bajos. La Iniciativa Internacional Escaneando el Horizonte (IHSI) comenzó en 9 pequeños países europeos 63 Los Países Bajos almacenan medicamentos para luchar contra el desabastecimiento; millones ahorrados en medicamentos caros 63 El partido laborista de RU quiere que el gobierno fabrique sus propios medicamentos para abaratar los precios 64 EE UU y Canadá El descubrimiento canadiense que se convirtió en el medicamento más caro del mundo y luego desapareció, tiene una segunda oportunidad 64 EE UU.
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