Regulatory Focus™ > News Articles > Inspections in China to Increase Under Proposed FDA Budget

Inspections in China to Increase Under Proposed FDA Budget

Posted 16 February 2012 | By Alexander Gaffney, RAC 

The Obama administration's proposed Fiscal Year 2013 budget will increase the US Food and Drug Administration's (FDA) funding for facility inspections in China by $10 million, agency officials confirmed.

In a call with reporters on 13 February, FDA Assistant Commissioner for Budget Patrick McGarey said that the "Fiscal Year 2013 budget contains some strategic increases that will help speed the availability of new medical products, help FDA address the challenges of globalization, and allow FDA to meet its public health responsibilities."

"We have a $10 million initiative related to China," said McGarey, adding the initiative "will allow FDA to enhance its collaboration with our Chinese counterparts and increase FDA's presence in China."

"[FDA's] understanding of the exports that we have coming from china both food and drugs" will be improved by the increased funded, added McGarey.

The $10 million in funding is split in to $4.4 million for food-related inspections and $5.6 million for drug products.

 "One of the principles of this [Generic Drug User Fee Act (GDUFA)] agreement is that we would inspect foreign facilities manufacturing generic drugs or manufacturing the bulk ingredients that go in to those drugs-the ingredients that are compounded for those drugs-as  frequently as our domestic industry," said McGarey. "That will give assurances to patients that the level of scrutiny that the medications are being subjected to is parallel whether it is [manufactured by] a domestic or foreign manufacturer."

Congressional Attention

The issue of foreign inspections received significant amounts of attention during a House Energy and Commerce Committee Hearing on the Prescription Drug User Fee Act (PDUFA) on 1 February 2012.

US-based manufacturers currently experience factory re-inspections every two years on average, while foreign manufacturers typically are inspected once every decade. In a CNN op-ed posted 1 February, Representative John Dingell (D-MI) cited a Government Accountability Office report that said that "some of the 3,765 foreign drug establishments in the FDA's database may never have been inspected. An increasing demand, coupled with an expanding globalized drug market, blatantly calls for a more globalized and fully equipped FDA."

"Now, more than ever, US manufacturing facilities should be rewarded, not penalized, for retaining jobs in the United States," said Dingell. "It is not only fair and the right thing to do to protect American competitiveness, it's critically important for the health of American consumers."

Hamburg noted during the hearing that the agency is in need of additional funds to ensure the capability of the agency to monitor clinical trials and inspect foreign manufacturers. "We need additional resources to provide the level of oversight that we believe is adequate," said Hamburg. Parity between domestic and foreign manufacturers would go a long way in securing the domestic drug supply and stemming the flow of manufacturers out of the country, she added.

The increase in funding should allow FDA to expand their operation in China, which was established in 2009, significantly.

FDA stands to receive $4.5 billion dollars in appropriated funds and industry-generated user fees in Fiscal Year 2013-a 17% increase over its Fiscal Year 2012 budget. The bulk of that increase-98%-is due to an increase in user fees that the agency expects to collect. 


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