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Of the residuary estate, after bequests to relatives and employees, four-fifths was designated for the ....
residuary
(rĭ-zĭj'ū-ĕr'ē)
adj.
- Of, relating to, or constituting a residue.
- Law. Entitled to the residue of an estate.
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
outpost
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