FDA Highlights Hands-On Approach To China Inspections In Budget Plan

The budget request targets an increase in pharmaceutical programs’ budget authority to boost the number of FDA staff focused on China’s manufacturing. The proposed $10 million increase, including $5.6 million to be allocated toward manufacturing, provides for additional inspections, educational efforts and inspectors in China.

The White House’s fiscal 2013 budget request reflects FDA’s emphasis on more collaboration with other countries as the only workable long-term approach to ensuring global drug production quality, but also underscores that the agency wants more of its own inspectors on the scene in China.

The Obama administration’s request targets the increase in budget authority – money provided from the general Treasury rather than from user fees – for pharmaceutical programs to boost the number of FDA staff focused on China manufacturing. The proposed $10 million increase, about $5.6 million of which would be allocated toward drug manufacturing, provides for additional inspections and educational efforts in that country. The funds would allow for nine new inspectors in China.

The Feb. 13 budget request does highlight some initiatives that fit with FDA’s globalization plans, but those activities get much less in the way of a funding nod compared to the stated increase in personnel for foreign inspections. International collaboration in manufacturing inspections includes information sharing, joint inspections and even relying on inspections by non-U.S. officials.

For all of FDA’s activities in drugs and other areas, the administration seeks a $4.5 billion budget in 2013, with $2 billion from user fees (Also see "Sanofi-Aventis offer" - Pink Sheet, 31 May, 2004.).

Funding for inspections both domestic and foreign is included in many areas. For example, $20 million in anticipated user fees for the new biosimilars review program would allow for staff to be trained in preparation for 30 domestic pre-approval inspections for biosimilars in fiscal 2015 and 12 overseas inspections the follow year. About $48 million of the anticipated $299 million in generic drug user fees would be budgeted so that 123 staffers could conduct inspections of foreign plants.

Domestic Vs. Foreign Distinction Is “Obsolete”

Although the request for China is small in comparison to user-fee funded inspections, it is highlighted throughout FDA’s budget documents. The approach, if approved by Congress, would enable FDA to plan for bolstered activity without depending on fees from manufacturers.

FDA’s emphasis could play well on Capitol Hill more than four years after tainted heparin from China began reaching the U.S., which continues to vex some lawmakers (Also see "FDA Foreign Inspections User Fee Program Getting Push On The Hill" - Pink Sheet, 18 Jul, 2011.). The proposed budget plan includes a similar increase for food plant inspections in China.

Global production of FDA-regulated products has “increased dramatically,” FDA notes in explanatory documents accompanying the 2013 request. Not only are more finished products imported, it notes, but manufacturers increasingly use imported materials in their U.S. plants, so much so that FDA says “this trend makes the distinction between domestic and imported products obsolete.” And China is a “source of a large and growing volume” of both finished drug products and drug ingredients.”

New Inspectors Based In Shanghai, Guangzhou

If the requested funds become available, the nine new inspectors hired would be based in Guangzhou and Shanghai for drug-related activities; FDA already has offices in those cities. Another two analysts would be hired at FDA’s headquarters in Silver Spring, Md., the agency said.

The educational efforts that would be included in the funding for inspections would allow FDA to conduct outreach to Chinese manufacturers to meet FDA good manufacturing practices and other requirements.

The agency also plans to expand its risk analytics to better target resources to high-risk drugs and ingredients made in China, according to budget documents.

That would fit with the globalization plan, which seeks to better target FDA resources to high-risk activities and collaborate with other regulators to share the foreign inspection workload (Also see "FDA Envisions International Focus Groups Navigating Globalization Issues" - Pink Sheet, 10 Oct, 2011.).

The risk analysis effort would be allotted $562,500, about 11% of the total new spending on the drug-related portion of the initiative.

FDA said it would be premature to speculate whether the expanded risk analysis could be used to target resources in other countries.

Agency Contemplates Foreign Offices’ Best Role

FDA still is thinking about how best to use its foreign offices, including China.

The agency has more than a dozen foreign posts around the world, with personnel stationed to handle inspections in the local area. That includes three in China: Beijing, Shanghai and Guangzhou.

Deborah Autor, deputy commissioner for global regulatory operations and policy, cautioned in a speech to the Alliance for a Stronger FDA that expanding existing foreign offices and creating new ones should not be taken for granted.

The offices are still in their early phase and their ideal role is not yet clear, Autor said Feb. 8.

“I think we have a lot of work to do to figure out how to maximize their use,” she said. “They’ve been terrific, but we want to think more about how to continue to be as strategic and leveraged as possible.”

While increased manpower will help, the agency knows it must look beyond its own staff to meet inspection and quality control requirements. FDA’s globalization plan, released in 2011, is intended to create a framework for dealing with the issue (Also see "FDA Global Pharma Safety Plan Looks To Food Model" - Pink Sheet, 27 Jun, 2011.).

Autor and other FDA officials assert the agency must at some point be able to rely on trusted foreign regulators for information, ideally to better target the agency’s own resources.

Private third parties also could handle more routine work, allowing FDA to devote more resources to risky areas, Autor said. Following the speech, she said third-party training programs still are under consideration for the drug manufacturer inspections, but are further along in the dietary supplement and food product and medical device areas.

Autor noted the agency also wants the authority to conduct remote facility inspections when appropriate. Records would be sent to the agency and reviewed, eliminating the need for inspectors to review them on-site.

Still, some signs point to the agency growing its own foreign inspection capacity.

The pending generic drug user fee agreement between FDA and industry would devote revenue toward increasing the number of foreign facility inspections with the goal of achieving parity with domestic inspections (Also see "Generic Facility Fee Unlikely To Be Charged Until A Few Months After GDUFA Implementation" - Pink Sheet, 19 Dec, 2011.).

The Senate also appears interested in creating a user fee specifically for foreign inspections. Similar legislation proposed in the House by Rep. John Dingell, D-Mich., has stalled (Also see "Inspection Fees Face Tough Road In Congress As PhRMA Remains Opposed" - Pink Sheet, 13 Feb, 2012.).

International Office Passed “Exchange” Target

In a nod to the collaboration efforts with other countries, FDA’s budget request justification documents indicate efforts by FDA’s Office of Global Regulatory Operations and Policy to work more closely with other regulators around the world.

In fiscal 2013, the office has a goal of having 2,100 “exchanges of confidential information received and shared with foreign counterpart bodies,” according to budget documents.

The budget request did not include further detail on what was meant by information exchanges and no target was listed for fiscal 2012.

The agency already seems to be performing at this level. FDA said the Office of International Programs, which is part of the global regulatory operations office, in fiscal 2011 had 2,200 non-public information exchanges with foreign regulators.

FDA said the 2013 metric was established before the end of fiscal 2011 and the emphasis going forward will be on the quality of information exchanges, not necessarily the quantity.

Autor said FDA’s ability to share confidential information with other countries also needs expansion. By law, some information still must be redacted before it can be shared, which prompts questions from some other governments.

“It actually creates a lot of friction in relationships,” she said.

The State Department also has said China needs to improve its regulatory system and assume more responsibility for the drugs sold in the country and exported. It and FDA have considered expanding programs to bring foreign regulators to the U.S. for training (Also see "Foreign Regulator Exchange Program Contemplated By U.S. State Department" - Pink Sheet, 16 Jan, 2012.).

While FDA’s budget highlights medical products imported from China, the White House has also been emphasizing U.S. exports to China. In November, President Obama toured India, Indonesia, Japan and South Korea for 10 days as part of a push to increase U.S. exports to the region and to bolster regional stability.

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