| Ken Block Consulting |
美國政府將FDA 列入"高風險" 名單
美國政府審計局, U.S. Government Accountability Office, (又簡稱GAO) 是一重要專門監督美國政府的獨立機構.
其最重要工作是分析美國政府各局處表現, 再報告於美國國會. 而在過去兩年裡, 美國政府審計局已提列28個區域為高風險
群.
一般而言, 所謂的高風險群表示:
此單位為:
1. 易受欺詐, 浪費, 濫用, 管理不善或/及
2. 需要廣泛基礎變革/改革, 以解決主要的經濟, 效率或有效的挑戰.
於2009 年 1月23號, 美國政府審計局已加入3個新高風險群, 包括FDA - 美國食品和藥物管理局.
以下文章部份摘取於美國政府審計局官方網站:
其最重要工作是分析美國政府各局處表現, 再報告於美國國會. 而在過去兩年裡, 美國政府審計局已提列28個區域為高風險
群.
一般而言, 所謂的高風險群表示:
此單位為:
1. 易受欺詐, 浪費, 濫用, 管理不善或/及
2. 需要廣泛基礎變革/改革, 以解決主要的經濟, 效率或有效的挑戰.
於2009 年 1月23號, 美國政府審計局已加入3個新高風險群, 包括FDA - 美國食品和藥物管理局.
以下文章部份摘取於美國政府審計局官方網站:
© 2007 Ken Block Consulting
“…Protecting public health through enhanced oversight of medical products. Concerns have been expressed
about FDA's ongoing ability to fulfill its mission of ensuring the safety and efficacy of drugs, biologics, and
medical devices. GAO's work examining a variety of issues at FDA echoes the conclusions reached by others
that the agency is facing significant challenges that compromise its ability to protect Americans from unsafe
and ineffective products. FDA needs to, among other things, improve the data it uses to manage the foreign
drug inspection program, conduct more inspections of foreign establishments, systematically prioritize and
track promotional materials for review, and adopt management tools to ensure that drug sponsors comply with
regulations on the presentation of clinical trial results.”
“…Americans depend on the Food and Drug Administration (FDA), an agency within the Department of Health
and Human Services (HHS), to ensure the safety and effectiveness of medical products—drugs, biologics, and
medical devices—marketed in the United States. The agency’s medical product responsibilities are far-
reaching and apply to such products regardless of whether they are manufactured domestically or overseas.”
“…FDA’s ability to ensure the quality of medical products manufactured overseas is an area of particular
concern.”
about FDA's ongoing ability to fulfill its mission of ensuring the safety and efficacy of drugs, biologics, and
medical devices. GAO's work examining a variety of issues at FDA echoes the conclusions reached by others
that the agency is facing significant challenges that compromise its ability to protect Americans from unsafe
and ineffective products. FDA needs to, among other things, improve the data it uses to manage the foreign
drug inspection program, conduct more inspections of foreign establishments, systematically prioritize and
track promotional materials for review, and adopt management tools to ensure that drug sponsors comply with
regulations on the presentation of clinical trial results.”
“…Americans depend on the Food and Drug Administration (FDA), an agency within the Department of Health
and Human Services (HHS), to ensure the safety and effectiveness of medical products—drugs, biologics, and
medical devices—marketed in the United States. The agency’s medical product responsibilities are far-
reaching and apply to such products regardless of whether they are manufactured domestically or overseas.”
“…FDA’s ability to ensure the quality of medical products manufactured overseas is an area of particular
concern.”
在此段文章指出:
“...政府需加強監督醫療產品, 以保護公眾健康. 而GAO已對FDA是否能完成其使命, 持續確保藥物,生物製品及醫療
設備的安全和療效表示關注. GAO對FDA的多項審查工作已顯示出FDA即將面對重大的挑戰來確保及保護美國國民
免受不安全和無效產品. FDA不僅需要改進其對外國藥品檢查計劃, 更要以優先次序法來進行更多對外國機構的檢
查, 包括審核其宣傳資料及使用各管理工具來確保藥品提供商有確實遵守法規提交臨床試驗結果.”
“...美國人民依賴FDA, 一個美國衛生部內的管理機構, 以確保銷售在美國醫療產品, 藥品, 生物製品, 及醫療設備安
全和有效性. 而該機構在醫療產品上的責任是遠大的, 它包含了無論在國內或國外製造的產品."
“...FDA在為確保海外生產的醫療產品品質的能力是一個特別令人關切的問題.”
“...政府需加強監督醫療產品, 以保護公眾健康. 而GAO已對FDA是否能完成其使命, 持續確保藥物,生物製品及醫療
設備的安全和療效表示關注. GAO對FDA的多項審查工作已顯示出FDA即將面對重大的挑戰來確保及保護美國國民
免受不安全和無效產品. FDA不僅需要改進其對外國藥品檢查計劃, 更要以優先次序法來進行更多對外國機構的檢
查, 包括審核其宣傳資料及使用各管理工具來確保藥品提供商有確實遵守法規提交臨床試驗結果.”
“...美國人民依賴FDA, 一個美國衛生部內的管理機構, 以確保銷售在美國醫療產品, 藥品, 生物製品, 及醫療設備安
全和有效性. 而該機構在醫療產品上的責任是遠大的, 它包含了無論在國內或國外製造的產品."
“...FDA在為確保海外生產的醫療產品品質的能力是一個特別令人關切的問題.”
若您希望詳讀此GAO完整文章（英文）請不吝聯繫我們.
也歡迎諮詢FDA的“高風險”的情況包括相關外國醫療設備檢查的內容.
相關新聞: http://www.nytimes.com/2009/01/16/washington/16device.html?_r=1
GAO 官方網站: http://www.gao.gov/
也歡迎諮詢FDA的“高風險”的情況包括相關外國醫療設備檢查的內容.
相關新聞: http://www.nytimes.com/2009/01/16/washington/16device.html?_r=1
GAO 官方網站: http://www.gao.gov/