China Illustrates Challenges for 'Global' FDA
Faced with a chronic shortage of staff around the world and a lack of enforcement authority in foreign countries, the FDA has come up with a plan to transform itself into a 'truly global agency,' according to a report (pdf) on product safety and quality it released on Monday.
But there isn't more funding to put boots on the ground. Nor is it clear how the agency will acquire sharper teeth.
The FDA has asked repeatedly for additional funding from Congress to help it take on these expanded duties, but it's funding for fiscal year 2012 was actually cut by $284 million compared to 2011.
Nowhere are the global challenges of the FDA more apparent than China -- the agency's first international outpost -- where it has just 13 staff spread across three cities in a country that sent $4.9 billion in agricultural and seafood exports to the U.S. in 2007.
The agents on the ground aren't just poking around factories to spot problems. They've also got to establish relationships with local government counterparts and work with industry that want to export products to the U.S. to make sure they understand and to help navigate the FDA approval process.
In a recent interview, Christopher Hickey, the FDA's Country Director in China, says that when it comes to inspections, merely getting access to foreign facilities for inspection can be difficult, since the FDA has no authority to compel overseas manufacturers to let them in. And while the agency can slap a so-called import alert on a company that refuses FDA inspection, which results in the inspection of products at the U.S. border, the FDA doesn't have the authority to destroy products at the border without a lengthy court battle. Instead, it generally can only turn products away at port.
With drug makers, of the 6000 or so companies in China that produce drugs or active pharmaceutical ingredients, 40% to 60% aren't operating in compliance of good manufacturing practices, according to Mr. Hickey. Conveying the processes and requirements necessary to produce a safe product by U.S. standards is 'a clear challenge,' he says.
The office has been holding seminars to educate companies about these practices, as well as training sessions and mock inspections for Chinese regulatory authorities to understand how the FDA conducts its inspections, with more planned for later this year.
Several times a week, staff members 'troll' Chinese news outlets, talk with industry sources, local regulatory authorities, academics to track events, trends and news that could affect the safety of FDA-regulated products, says Mr. Hickey.
Such monitoring has led to some small early success: Last year, it learned from Chinese press that black-eye peas grown in a province in southern China were being sprayed with toxic pesticides that could cause cancer, says Mr. Hickey. Though the issue was reported as a domestic one, the staff in Guangzhou reported the concern to Beijing, who passed it on to their FDA colleagues in Washington.
Additional research found that the pesticide was considered illegal in China but readily available. Ultimately the FDA alerted its screening agents so they could look for these products at the U.S. border and conduct testing on them.
Though that specific product wasn't being shipped to the U.S., the staff identified other similar ones and processed foods that might contain the peas as one of its ingredients as ones that might be risky.
'Before we had an office here, there were not individuals at the FDA for closely following, for instance, the Chinese press,' said Mr. Hickey. 'I think we have helped to strengthen the safety of food coming from China.'
But some government officials and watchdog groups have been critical of the FDA's efforts. A September U.S. Government Accountability Office report (pdf) on the FDA's overseas offices identified several challenges to establishing effective overseas offices, including staffing difficulties, communication issues between the field offices and agency headquarters about what information needs to be gathered and an overall greater need for long-term planning.
Key among their concerns is the FDA's ability to conduct an adequate number of inspections of food and drug manufacturing facilities. While the FDA inspects domestic drug manufacturers an average of every 2.5 years, most drug facilities in China are inspected by FDA inspectors only every nine years or so, according to Allan Coukell of the Pew Charitable Trusts, who has been researching the safety of the U.S. drug-supply chain.
Some in Congress and the FDA itself says that more fundamental issues involve funding and the agency's lack of enforcement authority when it comes to goods produced abroad.
In April, eight Democratic House representatives introduced a bill, called the Drug Safety Enhancement Act, which would enhance the FDA's enforcement powers regarding imported drugs in the way that the FDA Food Safety Modernization Act, signed into law in January, strengthens its enforcement abilities over food.
'It's slow-going,' said Marcia Crosse, a director of health care at the GAO who co-authored the report, of the FDA's efforts to set up the international offices and better monitor imported products. 'I do understand it takes a long time and yet my concern is it not take another decade.'
Shirley Wang
But there isn't more funding to put boots on the ground. Nor is it clear how the agency will acquire sharper teeth.
The FDA has asked repeatedly for additional funding from Congress to help it take on these expanded duties, but it's funding for fiscal year 2012 was actually cut by $284 million compared to 2011.
Nowhere are the global challenges of the FDA more apparent than China -- the agency's first international outpost -- where it has just 13 staff spread across three cities in a country that sent $4.9 billion in agricultural and seafood exports to the U.S. in 2007.
The agents on the ground aren't just poking around factories to spot problems. They've also got to establish relationships with local government counterparts and work with industry that want to export products to the U.S. to make sure they understand and to help navigate the FDA approval process.
In a recent interview, Christopher Hickey, the FDA's Country Director in China, says that when it comes to inspections, merely getting access to foreign facilities for inspection can be difficult, since the FDA has no authority to compel overseas manufacturers to let them in. And while the agency can slap a so-called import alert on a company that refuses FDA inspection, which results in the inspection of products at the U.S. border, the FDA doesn't have the authority to destroy products at the border without a lengthy court battle. Instead, it generally can only turn products away at port.
With drug makers, of the 6000 or so companies in China that produce drugs or active pharmaceutical ingredients, 40% to 60% aren't operating in compliance of good manufacturing practices, according to Mr. Hickey. Conveying the processes and requirements necessary to produce a safe product by U.S. standards is 'a clear challenge,' he says.
The office has been holding seminars to educate companies about these practices, as well as training sessions and mock inspections for Chinese regulatory authorities to understand how the FDA conducts its inspections, with more planned for later this year.
Several times a week, staff members 'troll' Chinese news outlets, talk with industry sources, local regulatory authorities, academics to track events, trends and news that could affect the safety of FDA-regulated products, says Mr. Hickey.
Such monitoring has led to some small early success: Last year, it learned from Chinese press that black-eye peas grown in a province in southern China were being sprayed with toxic pesticides that could cause cancer, says Mr. Hickey. Though the issue was reported as a domestic one, the staff in Guangzhou reported the concern to Beijing, who passed it on to their FDA colleagues in Washington.
Additional research found that the pesticide was considered illegal in China but readily available. Ultimately the FDA alerted its screening agents so they could look for these products at the U.S. border and conduct testing on them.
Though that specific product wasn't being shipped to the U.S., the staff identified other similar ones and processed foods that might contain the peas as one of its ingredients as ones that might be risky.
'Before we had an office here, there were not individuals at the FDA for closely following, for instance, the Chinese press,' said Mr. Hickey. 'I think we have helped to strengthen the safety of food coming from China.'
But some government officials and watchdog groups have been critical of the FDA's efforts. A September U.S. Government Accountability Office report (pdf) on the FDA's overseas offices identified several challenges to establishing effective overseas offices, including staffing difficulties, communication issues between the field offices and agency headquarters about what information needs to be gathered and an overall greater need for long-term planning.
Key among their concerns is the FDA's ability to conduct an adequate number of inspections of food and drug manufacturing facilities. While the FDA inspects domestic drug manufacturers an average of every 2.5 years, most drug facilities in China are inspected by FDA inspectors only every nine years or so, according to Allan Coukell of the Pew Charitable Trusts, who has been researching the safety of the U.S. drug-supply chain.
Some in Congress and the FDA itself says that more fundamental issues involve funding and the agency's lack of enforcement authority when it comes to goods produced abroad.
In April, eight Democratic House representatives introduced a bill, called the Drug Safety Enhancement Act, which would enhance the FDA's enforcement powers regarding imported drugs in the way that the FDA Food Safety Modernization Act, signed into law in January, strengthens its enforcement abilities over food.
'It's slow-going,' said Marcia Crosse, a director of health care at the GAO who co-authored the report, of the FDA's efforts to set up the international offices and better monitor imported products. 'I do understand it takes a long time and yet my concern is it not take another decade.'
Shirley Wang
2011年 06月 27日 07:22 FDA欲全球化 中國成最大挑戰
Nelson Ching/Bloomberg
2010年11月5日﹐中國深圳﹐技術人員正在藥品生產車間工作。
美
國食品和藥物管理局(FDA)週一發佈了一份有關產品安全和質量的報告。報告顯示﹐鑒於FDA國際辦事處長期缺少工作人員﹐且它在海外缺乏執行權﹐因此FDA提出了一個將自己轉變為“真正全球性機構”的計劃。但現在沒有更多資金支持海外辦事處建設﹐另外也不清楚FDA將如何獲得更多執行權。
FDA曾多次要求美國國會給它額外撥款﹐以幫助其承擔這些範圍更廣的職責﹐但實際上﹐國會為該機構2012財年提供的資金與2011年相比竟然減少了2.84億美元。
Eugene Hoshiko/Associated Press
2010年8月13日﹐FDA專員Margaret Hamburg參觀上海市食品藥品檢驗所的一個實驗樓。
這些辦事處的日常工作並非只是檢查相關工廠以發現問題。它們還要與中國當地政府的對口部門建立關係﹐並與那些希望向美國出口的行業進行合作﹐確保它們理解並幫助它們完成FDA的審批程序。
FDA 駐中國的負責人希基(Christopher Hickey)前不久接受採訪時說﹐提到檢查﹐光是想辦法進入外國工廠可能就是件難事﹐因為FDA無權命令外國生產商為其敞開大門。雖然FDA可對拒絕接 受檢查的公司給出所謂的進口預警通報(import alert)(即產品抵達美國邊境時要接受檢查)﹐但若不經歷一番長時間的官司糾纏﹐FDA沒有權力在美國邊境銷毀這些產品。一般來說﹐它所能做的﹐只不 過是把這些產品拒之美國國門之外。
希基表示﹐中國生產藥物或活性藥物成分的公司有6000家左右﹐其中40%至60%的製藥商在經營上沒有遵守良好的生產規范。他說﹐向這些公司宣傳按照美國標準生產安全產品所需的程序和要求﹐這顯然是個挑戰。
為向中國公司宣傳良好的生產規范﹐FDA舉辦了多場研討會。此外﹐為讓中國監管當局瞭解其檢查方式﹐FDA還展開了專項培訓和模擬檢查。今年晚些時候FDA計劃推出更多這類活動。
希基說﹐FDA員工每周都要察訪好幾次新開的中國工廠﹐並與業內消息人士、當地監管機構和專家學者進行談話﹐以瞭解那些可能影響FDA相關產品安全的事件、動向和消息。
這類監控措施已經取得了一些初步成功。希基說﹐去年該機構通過中國的報紙瞭解到﹐中國南方某省生產的豇豆被噴洒了可能致癌的有毒農藥。雖然據說該事件只發生在中國國內﹐但FDA廣州辦事處的員工還是將此事匯報給了北京辦事處﹐後者又將其通報給華盛頓的同事。
FDA對此展開了其它調查併發現﹐這種農藥雖在中國被列為禁用農藥﹐但很容易就可買到。最後﹐FDA向隸屬檢查機構發出警報提醒﹐要求它們尋找是否有運抵美國邊境的豇豆類產品﹐一旦發現應予以檢測。
雖然上述有毒豇豆沒有輸往美國﹐但FDA人員發現了其它類似豇豆以及配料中可能含有這種有毒豇豆的加工食品。
希基說﹐我們在中國設辦事處之前﹐FDA沒有人專門負責密切關注中國報紙上的相關消息﹐我覺得我們在一定程度上加強了中國輸美食品的安全性。
但 一些政府官員和監察組織卻對FDA的努力感到不滿。美國政府問責局(Government Accountability Office)去年9月發佈了一份有關FDA海外辦事處的報告。報告發現﹐在海外建立有效辦事處存在幾大挑戰﹐包括人員配備困難和辦事處和總部之間的溝通 問題等﹐例如辦事處應收集哪些信息以及需要加大力度進行長遠規劃等。
這些挑戰中﹐最關鍵的是FDA是否有能力對食品和藥品生產企業發起足 夠多的檢查。美國皮尤慈善信托基金會(Pew Charitable Trusts)的庫克爾(Allan Coukell)表示﹐雖然FDA平均每隔兩年半就對美國本土製藥商進行檢查﹐但對中國大多數製藥商來說﹐FDA差不多每九年才檢查一次。該基金會一直負 責美國藥物供應鏈的安全研究。
美國國會某些議員和FDA自己都說﹐更根本的還是資金問題以及FDA缺乏對國外產品的執行權問題。
今年4月﹐八位民主黨眾議員提出了一項名為《藥品安全加強法案》(Drug Safety Enhancement Act)的議案﹐若獲得通過﹐可加強FDA對進口藥品的執行權。今年1月﹐《FDA食品安全現代化法案》(FDA Food Safety Modernization Act)獲得簽署通過並成為法律﹐增強了FDA對食品的執行能力。
美國政府問責局衛生保健主管、該報告合著者之一克羅斯(Marcia Crosse)說﹐FDA試圖在全世界建立辦事處並更好地監督進口產品﹐這是一項進展緩慢的工作﹔我非常能理解這項工作要花很長一段時間才能完成﹐而我關心的是﹐這個過程會不會還需10年時間。
Shirley Wang
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