{"id":3762,"date":"2023-03-13T03:45:11","date_gmt":"2023-03-13T07:45:11","guid":{"rendered":"https:\/\/worldvapersalliance.com\/?p=3762"},"modified":"2023-03-13T03:39:34","modified_gmt":"2023-03-13T07:39:34","slug":"fda-misses-the-point-again-reagan-udall-evaluation","status":"publish","type":"post","link":"https:\/\/worldvapersalliance.com\/de_de\/fda-misses-the-point-again-reagan-udall-evaluation\/","title":{"rendered":"Die FDA verfehlt erneut den Kern der Sache: Reagan-Udall-Bewertung"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">Im Jahr 2022 k\u00fcndigte FDA-Kommissar Califf eine \u00dcberpr\u00fcfung des Zentrums f\u00fcr Tabakprodukte durch die Reagan-Udall-Stiftung an. <\/span><span style=\"font-weight: 400;\">Das Fundament\u00a0<\/span><a href=\"https:\/\/reaganudall.org\/sites\/default\/files\/2022-12\/Tobacco%20report%20210pm.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">sagte<\/span><\/a><span style=\"font-weight: 400;\">\u00a0dass das CTP \u201ceine entscheidende Aufgabe hat, die \u00f6ffentliche Gesundheit vor tabakbedingten Krankheiten und Todesf\u00e4llen zu sch\u00fctzen und Produkte reguliert, die keinen inh\u00e4renten Nutzen haben und enorme gesellschaftliche Kosten verursachen; es ist ein staatliches Regulierungsprogramm mit der Pflicht, effizient, fair und transparent zu funktionieren.\u201d Sie auch\u00a0<\/span><a href=\"https:\/\/www.vapingpost.com\/2023\/03\/03\/us-the-fdas-ctp-review-uncovers-multiple-issues\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">berichtete<\/span><\/a><span style=\"font-weight: 400;\">\u00a0Es mangelte an Klarheit und Transparenz sowie an interner Kommunikation. Dar\u00fcber hinaus stellten sie fest, dass die CTP nicht f\u00fcr die mit dem PMTA-Verfahren und anderen ihr \u00fcbertragenen regulatorischen Aufgaben verbundene Arbeitsbelastung ger\u00fcstet ist.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cDer fast 40-seitige Bericht hob hervor, dass Reagan-Udall \u201ckeinen aktuellen umfassenden Plan vorlegen konnte, der die Priorit\u00e4ten, die zuk\u00fcnftige Ausrichtung sowie die kurz- und langfristigen Ziele und Vorgaben des CTP klar darlegt\u201d. Zu den weitreichenden Vorschl\u00e4gen geh\u00f6rten die Verbesserung der Kommunikation und Transparenz, beispielsweise durch eine \u00f6ffentliche Anh\u00f6rung; die Einf\u00fchrung von Methoden, die eine st\u00e4rkere Einbindung der Interessengruppen erm\u00f6glichen; die Entwicklung klarerer Rahmenbedingungen f\u00fcr qualitativ hochwertige Zulassungsantr\u00e4ge f\u00fcr Nikotinprodukte sowie die verst\u00e4rkte Einbindung des wissenschaftlichen Beirats f\u00fcr Tabakprodukte.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Wie f\u00fcr die FDA typisch, besteht ihre L\u00f6sung f\u00fcr diese gravierenden M\u00e4ngel im CTP darin, den Kongress aufzufordern, die Einf\u00fchrung von Nutzungsgeb\u00fchren zu genehmigen, um die durch den PMTA-Prozess verursachten \u201cArbeitskosten\u201d zu decken. Er sagte: \u201cUm diese Ziele zu erreichen, ben\u00f6tigen wir die entsprechenden Ressourcen, um Personal mit den erforderlichen Qualifikationen einzustellen und zu halten, damit wir unseren Auftrag im Bereich der \u00f6ffentlichen Gesundheit in Bezug auf Tabak effektiv erf\u00fcllen k\u00f6nnen.\u201d Mir gehen bei solchen Aussagen einige Fragen durch den Kopf: Nutzungsgeb\u00fchren \u2013 von wem verursacht? Und das soll eine L\u00f6sung f\u00fcr die von RUF genannten Probleme sein? Sie kassieren dein Geld und machen dich dann platt. Klingt echt logisch!\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In einem anderen<\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-outlines-steps-strengthen-tobacco-program\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\"> Stellungnahme von Califf in dieser FDA-Pressemitteilung<\/span><\/a><span style=\"font-weight: 400;\"> Er bekr\u00e4ftigt die Falschinformationen, indem er erkl\u00e4rt:\u201c<\/span><span style=\"font-weight: 400;\">Leider hat die Tabakindustrie viele der von uns ergriffenen wissenschaftlich fundierten Ma\u00dfnahmen der Beh\u00f6rde bek\u00e4mpft \u2013 Profite wurden dabei \u00fcber die \u00f6ffentliche Gesundheit gestellt. Obwohl wir beispielsweise als einziges Land weitreichende Regulierungsbefugnisse \u00fcber die Tabakindustrie besitzen, wurden wir im Gegensatz zu vielen anderen Nationen bisher zweimal durch Klagen daran gehindert, die vom Kongress vorgeschriebenen Warnhinweise auf Zigarettenpackungen umzusetzen, die auf die schwerwiegenden Gesundheitsrisiken des Rauchens hinweisen.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Das ist wirklich eine komische Aussage, da CTP ganz klar diejenigen sind, die den Profit \u00fcber die \u00f6ffentliche Gesundheit stellen, indem sie 99,991 % der eingereichten PMTA-Antr\u00e4ge ablehnen und den Konsum durch Jugendliche \u00fcber das Leben von Erwachsenen stellen.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Obwohl Dampfer von diesen Reaktionen auf den RUF-Test nicht \u00fcberrascht sind, betr\u00fcbt es mich dennoch, dass selbst dann, wenn solche Schritte unternommen werden, die m\u00f6glicherweise zu Ergebnissen f\u00fchren k\u00f6nnten, die nicht den gew\u00fcnschten Erfolg bringen. <\/span><b>(und sollte)<\/b><span style=\"font-weight: 400;\"> Obwohl wir bei der FDA echte Ver\u00e4nderungen versprechen, bleibt am Ende doch alles beim Alten.\u00a0<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>In 2022 FDA Commissioner Califf announced a review of its Center for Tobacco Products by the Reagan-Udall Foundation. The foundation\u00a0said\u00a0that the CTP \u201chas a critical mission to protect the public health from tobacco-related disease and death and is regulating products that have no inherent benefit and huge societal costs, it is a government regulatory program [&hellip;]<\/p>\n","protected":false},"author":15,"featured_media":3094,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17],"tags":[],"class_list":["post-3762","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Misses the Point, Again: Reagan-Udall Evaluation<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/worldvapersalliance.com\/de_de\/fda-misses-the-point-again-reagan-udall-evaluation\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Misses the Point, Again: Reagan-Udall Evaluation\" \/>\n<meta property=\"og:description\" content=\"In 2022 FDA Commissioner Califf announced a review of its Center for Tobacco Products by the Reagan-Udall Foundation. 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