FDA Reorg Could Streamline HQ Procedures, but Won't Affect Field Operations

Through its reorganization, FDA appears to be aligning itself for its new Food Safety and Modernization Act mandates, said Ed Steele, CEO of EAS Consulting Group. FSMA puts new regulatory responsibilities on importers to make sure they know food has been processed properly before entry into the U.S., he said. “There’s going to be quite a bit more activity that coordinates those activities from headquarters at FDA,” said Steele. With this reorganization, FDA “is trying to align itself to make that whole process more efficient.”

But the reorganization is “not going to impact the FDA field that much…and the only place it’s really going to have an impact on importers is going to be when they’re interacting with headquarters,” said Ben England, owner of FDAImports.com and former regulatory counsel to the FDA Associate Commissioner for Regulatory Affairs. Carl Nielsen, president of C. Nielsen Consulting and former director of the Division of Import Operations and Policy, agreed. The reorganization “looks like a headquarters shuffle again,” Nielsen said. “The big key out of the document to show that there’s not going to be any significant change on a day-to-day basis on the front line is there’s no change in the field,” he said, referencing the internal fact sheet.

(See ITT’s Online Archives 12091902 for summary of the fact sheet on reorganization, and 12100404 for summary of the leadership FDA has put into place to head the new offices. See also ITT’s Online Archives 11010426 for a comprehensive summary of FSMA’s mandates.)

Handling of Import Alerts, HQ Compliance Activities Could Benefit

FDA’s reorganization would “have no or little direct effect on the day-to-day import operations at the point of entry,” but “could mostly affect the post entry processes which are currently handled at the headquarters level,” said Roger Clarke of customs broker Williams Clarke Company.

“Traditionally, there has been great delay for importers in obtaining decisions and information regarding import compliance issues and removal from import alerts,” said Christine Humphrey of C. Humphrey & Associates. The impact of the reorganization won’t be felt immediately by importers, but it will eventually streamline communications between importers and FDA on import alerts and compliance issues, she said. It will also provide needed resources for the FDA’s implementation of new FSMA programs like the Foreign Supplier Verification Program, she said. Humphries estimated at least 18 months before the reorganization is implemented and importers feel any impact.

Response times could still be slow, however, said Clarke, who also is chair of the National Customs Brokers and Freight Forwarders Association of America’s Regulatory Agencies Committee. “Many of the new reorganized positions will be staffed by acting management, which can lead to a delayed response to possible operational issues,” he said.

But Day-to-Day Field Operations Remain Untouched

But according to Carl Nielsen, FDA’s field operations remain untouched by the reorganization, which poses problems for its ability to effectively utilize risk-based approaches. “What I see is that the import operations is still going to be stuck as an organization that reports to [an] upper management with little understanding or experience with international trade and related issues,” Nielsen said. If it was going to be a significant move, import and international operations would have been broken off from FDA’s domestic programs. “The FDA’s enforcement of imports is connected at the hip regulatory-wise with Customs, and you cannot separate the two,” he said. “There are a whole lot of other considerations when it comes to compliance as it relates to imports versus domestic operations.”

Both food safety and importers would be winners from separating FDA’s import and domestic programs, Nielsen said. Such an organization would have a better skill set, be better managed and more efficient, and “would be able to more effectively work with foreign industry on supply chain management versus looking at random samples based on an FDA product code that may or may not accurately reflect the product,” he said.

Instead, the new import office remains attached to the FDA’s domestic programs, and is still part of an ORA that does not have any direct budgetary authority. “Even though it’s 45-50 percent of all the resources of FDA…[ORA] has to get its money from the centers,¹ said England. ORA’s lack of budgetary autonomy, combined with its domestic focus, has resulted in a lack of nimbleness needed to effectively utilize risk-based approaches, he said.

Most district directors grew up on the domestic side of FDA’s operations, and so they don’t really understand imports or the foreign process, England said. The same is true for the centers as well. Meanwhile, budgets for field operations are determined as part of a “workplan” process that sets ORA’s budget, negotiated in advance with the product-focused centers. The result is that decisions on how many inspections should be performed can be untimely, and at times arbitrary rather than risk-based, England said. “The issue is that the agency isn’t nimble -- it doesn’t have the ability to move.”

Implementation of FSMA Depends on Leadership, not Reorganization

Ed Steele was more sanguine about FDA’s ability to implement FSMA. “The bottom line is the work that the FDA is going to do is always going to be resource-dependent in terms of what available resources they have,” he said. But within these constraints, direction from headquarters will be targeted to implement FSMA, he said. To that extent, the reorganization may impact the field, but that may be the case regardless of the reorganization, said Steele. “You can change all the boxes around, but it really gets down to the leadership of the agency itself.”

“I think there’s a strong commitment on the agency leadership today to implement FSMA,” Steele said, so reorganization isn’t going to diminish the intent or the ability of FDA to focus on its implementation.

¹The FDA’s product-based centers include the Center for Veterinary Medicine, the Center for Food Safety and Applied Nutrition, the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Center for Tobacco Products.