FDA proposes streamlining inspections office along with new human foods center

Regulatory NewsRegulatory News | 31 January 2023 |  By 

An FDA inspector from the Office of Regulatory Affairs. (Source: FDA)

The US Food and Drug Administration has proposed restructuring the Office of Regulatory Affairs (ORA) as part of its efforts to reform its food safety oversight program. Agency heads say the changes will eventually mean more efficiencies for ORA, but the reforms will not be as fast as they want due to resource constraints.
In the wake of the infant formula scandal and shortage over the past year, several top lawmakers have called on the FDA to reform its food regulatory oversight. On 31 January, the agency proposed doing precisely that by creating a Human Foods Program and giving it more authority to prevent future food supply shortages. The new program would bring the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), and certain functions of ORA under one roof (RELATED: House committee sends FDA budget to floor vote, Regulatory Focus, 23 June 2022).
The FDA also wants to appoint a deputy commissioner for human foods who reports directly to the FDA commissioner and put together a larger executive team to manage the food program.
To support these reforms, FDA officials propose broader reforms by restructuring ORA, which inspects regulated products and their manufacturers, conducts sampling of products, and reviews regulated products entering the US. The agency says the “new model” for ORA will better integrate the office with work at all the other centers that regulate products.
In particular, the restructuring of ORA is meant to improve risk prioritization and the public health impact of the FDA’s field activities while modernizing the work. The agency says it will also streamline ORA’s work across the product centers.
“As part of this proposed new vision, ORA’s operating structure will be transformed into an enterprise-wide organization that supports the Human Foods Program and all other FDA regulatory programs (e.g., agency centers) by focusing on its critical activities,” said FDA Commissioner Robert Califf in a statement. “This realignment will allow ORA to be singularly focused on excellence in its core mission – inspections, laboratory testing, import, and investigative operations. This will optimize ORA’s operations in line with the FDA’s public health and prevention-oriented goals. Certain other functions of ORA will be aligned in other parts of the FDA to create an overall stronger agency.”
FDA has spent the past year building an IT workflow management system that would enjoin the various product centers through the ORA, FDA Principal Deputy Commissioner Janet Woodcock said during a press conference. It’s meant to allow the agency to order, conduct and eventually address inspections through one platform, regardless of product type, rather than performing such tasks in silos as it is currently.
"There are like 11 different ways that centers can order inspections,” Woodcock said. “We are modernizing that infrastructure, and at the same time, we're going to change the business rules for how that all works."
While the agency wants to modernize the ORA, Woodcock acknowledged that there isn’t additional funding to do so. She said the agency has to work with the resources it currently has, whether through appropriations or user fee programs.
“This will slow down the transformation because devising the new business rules and business processes, particularly for inspections, is challenging,” said Woodcock. “It could be accelerated if we had more resources.”
Califf agreed and noted that the lack of funding is very different from his experience in the private sector. "Usually, when you make a transformation this major, you have additional resources brought in for a period of time,” he said.
Califf emphasized that he and Woodcock have talked to FDA staff, who are not only on board with the proposal but are enthusiastic about streamlining the work ORA does. He added that the change would not only make people’s work more efficient, but they are more likely to enjoy their work, and the outcome would be better.
“We’re going to do with what we have because that’s the way it works,” said Califf.
News of the FDA’s proposal was received positively by stakeholders, including Steven Mandernach, executive director at the Association of Food and Drug Officials (AFDO).
“In particular, we appreciate that [Califf’s] proposal elevates state and local programs who do much of the food safety work, creates a deputy commissioner with streamlined authority, and focuses the agency’s nutrition mission in a Center of Excellence for Nutrition,” Mandernach said in a statement. “We see additional opportunities to streamline the authority between the Deputy Commissioner for Human Foods and the Office of Regulatory Affairs and will continue to engage with the Commissioner on this issue.”
Steven Grossman, executive director at the Alliance for a Stronger FDA, cheered the proposal and said creating a new deputy commissioner for human foods isn’t just about differently arranging boxes on an organizational chart but also about empowering a decisionmaker with the ability to make real change.
“The responsibilities placed on FDA and the growth of challenges in food safety have increased far faster than funding,” Grossman said in a statement. “Significant new monies are needed to assure that the food supply is safe and perceived to be so, and nutritional information is widely available and supported by science.”


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