PharmAsia News
August 15, 2013
Executive Summary
The agency is waiting for approval to locate 10 new drug inspectors in China.
U.S. FDA has the funding to add a number of new inspectors to its offices in China, but diplomatic delays have so far prevented the agency from placing the personnel there to increase its inspectional capacity.
The Chinese government has yet to issue the necessary visas allowing 10 new drug inspectors and seven new food inspectors to locate there. But agency officials told the Alliance for a Stronger FDA Aug. 15 that they continue to move forward with hiring and planning for the staff to eventually head to the country.
Chris Hickey, director of FDA’s China office, said the length of the visa approval process was not surprising, given the size of the agency’s proposed staffing increase.
FDA now has one drug inspector, one device inspector and two food inspectors in China.
“The Chinese understand the importance of this issue to us,” Hickey said. “They understand that for us not only is the desire to have just more personnel in country but the responsibility that FDA has … to increase the number of inspections we’re doing.”
Hickey also said this is not an issue that would be specific to China.
“For any government, saying yes to this is a challenge,” he said. “The idea of having FDA inspectors, and not just a few, but a large number of them, based in your country is a big lift and a new concept ... It took us a while in 2007 and 2008 to socialize the idea of having an FDA office in the first place. So certainly the significant increase, we knew the approvals were not going to come overnight.”
FDA established three offices in China nearly five years ago as part of an effort to improve its ability to deal with the globalization of the drug supply chain.
The agency also has posts in South Africa, India, Mexico, Costa Rica, Chile, Jordan, and multiple locations in Europe. They allow FDA to conduct more foreign inspections quicker.
China also is working to improve its own enforcement efforts and recently announced a number of product recalls.
FDA received the funding to increase its presence in China in April when fiscal year 2013 appropriations were approved.
The agency asked for an additional $10 million in its budget specifically to increase inspections and training in China.
Short-Term Details Fill The Void
The visas have not been denied, and Hickey said the issue is being addressed at the highest levels of the U.S. and Chinese governments.
As the agency waits for approval, it is increasing short-term postings in China.
Mary Lou Valdez, FDA associate commissioner for international programs and director of the Office of International Programs, said after the meeting that the agency is trying to increase the number of 60- to 90-day details to China for its U.S. staff.
That not only helps fill the void that soon will be filled by the new full-time inspectors, but also gives staff who may be interested in relocating overseas a taste of what the job would be like.
Valdez said during the meeting that sending staff overseas remains a relatively new idea for FDA. She said staff members still think twice about whether they would like to move to a foreign country.
More Inspectors Are An Interim Step
FDA’s strategy for adapting to globalization includes better targeting resources at areas and activities that pose the most risk. Agency officials also want to work with other regulators to share information and the overall inspection workload.
The agency could form regulator coalitions based on specific issues, such as drugs or foods, to increase the information flow.
FDA also wants to eventually accept inspections conducted by other trusted regulators. It already has a number of agreements with European and Australian regulators that could allow an expansion of the practice.
Altaf Lal, director of FDA’s India Office, said during the meeting that the agency also would like India and China regulators to eventually become as inspection proficient as FDA.
He said the new agency staff in China and India will be working with their counterpart regulators to inform and train them on FDA standards.
FDA Commissioner Margaret Hamburg and others have said improving regulatory capacity in other countries also can serve economic development interests.
Where Should FDA Go Next?
The agency also may be considering where its next foreign offices should be located or thinking about whether existing offices are optimal to meet its needs.
Valdez said agency officials want information from industry and stakeholders about whether its overseas posts are in the right places as well as where they may need to locate in the future.
“We may not be thinking of Thailand today, but should we be because we know they’re on the horizon in two years or three years?” she said. “Where are we most effective if we want a toe-hold in Africa? Is South Africa really the best place to have that toe-hold?”
Valdez also said FDA should always be considering which staffing levels are most efficient and effective, as well as which skills are ideal for an overseas posting.
That likely will be particularly important as the agency continues to deal with a constrained budget.
President Obama’s FY 2014 budget request relied on user fees for nearly all of FDA’s proposed increase.
Executive Summary
The agency is waiting for approval to locate 10 new drug inspectors in China.
U.S. FDA has the funding to add a number of new inspectors to its offices in China, but diplomatic delays have so far prevented the agency from placing the personnel there to increase its inspectional capacity.
The Chinese government has yet to issue the necessary visas allowing 10 new drug inspectors and seven new food inspectors to locate there. But agency officials told the Alliance for a Stronger FDA Aug. 15 that they continue to move forward with hiring and planning for the staff to eventually head to the country.
Chris Hickey, director of FDA’s China office, said the length of the visa approval process was not surprising, given the size of the agency’s proposed staffing increase.
FDA now has one drug inspector, one device inspector and two food inspectors in China.
“The Chinese understand the importance of this issue to us,” Hickey said. “They understand that for us not only is the desire to have just more personnel in country but the responsibility that FDA has … to increase the number of inspections we’re doing.”
Hickey also said this is not an issue that would be specific to China.
“For any government, saying yes to this is a challenge,” he said. “The idea of having FDA inspectors, and not just a few, but a large number of them, based in your country is a big lift and a new concept ... It took us a while in 2007 and 2008 to socialize the idea of having an FDA office in the first place. So certainly the significant increase, we knew the approvals were not going to come overnight.”
FDA established three offices in China nearly five years ago as part of an effort to improve its ability to deal with the globalization of the drug supply chain.
The agency also has posts in South Africa, India, Mexico, Costa Rica, Chile, Jordan, and multiple locations in Europe. They allow FDA to conduct more foreign inspections quicker.
China also is working to improve its own enforcement efforts and recently announced a number of product recalls.
FDA received the funding to increase its presence in China in April when fiscal year 2013 appropriations were approved.
The agency asked for an additional $10 million in its budget specifically to increase inspections and training in China.
Short-Term Details Fill The Void
The visas have not been denied, and Hickey said the issue is being addressed at the highest levels of the U.S. and Chinese governments.
As the agency waits for approval, it is increasing short-term postings in China.
Mary Lou Valdez, FDA associate commissioner for international programs and director of the Office of International Programs, said after the meeting that the agency is trying to increase the number of 60- to 90-day details to China for its U.S. staff.
That not only helps fill the void that soon will be filled by the new full-time inspectors, but also gives staff who may be interested in relocating overseas a taste of what the job would be like.
Valdez said during the meeting that sending staff overseas remains a relatively new idea for FDA. She said staff members still think twice about whether they would like to move to a foreign country.
More Inspectors Are An Interim Step
FDA’s strategy for adapting to globalization includes better targeting resources at areas and activities that pose the most risk. Agency officials also want to work with other regulators to share information and the overall inspection workload.
The agency could form regulator coalitions based on specific issues, such as drugs or foods, to increase the information flow.
FDA also wants to eventually accept inspections conducted by other trusted regulators. It already has a number of agreements with European and Australian regulators that could allow an expansion of the practice.
Altaf Lal, director of FDA’s India Office, said during the meeting that the agency also would like India and China regulators to eventually become as inspection proficient as FDA.
He said the new agency staff in China and India will be working with their counterpart regulators to inform and train them on FDA standards.
FDA Commissioner Margaret Hamburg and others have said improving regulatory capacity in other countries also can serve economic development interests.
Where Should FDA Go Next?
The agency also may be considering where its next foreign offices should be located or thinking about whether existing offices are optimal to meet its needs.
Valdez said agency officials want information from industry and stakeholders about whether its overseas posts are in the right places as well as where they may need to locate in the future.
“We may not be thinking of Thailand today, but should we be because we know they’re on the horizon in two years or three years?” she said. “Where are we most effective if we want a toe-hold in Africa? Is South Africa really the best place to have that toe-hold?”
Valdez also said FDA should always be considering which staffing levels are most efficient and effective, as well as which skills are ideal for an overseas posting.
That likely will be particularly important as the agency continues to deal with a constrained budget.
President Obama’s FY 2014 budget request relied on user fees for nearly all of FDA’s proposed increase.
