Reorganization efforts at the Food and Drug Administration will “reduce the likelihood that a ball gets dropped” as the agency works to protect the U.S. food supply, says the leader of FDA's new human foods division.
Speaking on this week’s Agri-Pulse Newsmakers, FDA Deputy Commissioner for Human Foods Jim Jones says last year's infant formula crisis revealed the “structural flaw in the design” of FDA's leadership. Now, instead of having individuals with competing decision-making authority, Jones will be the "final decider on issues.”
One major problem exposed by the infant formula crisis was "there were so many different ways in which a complaint could be brought into FDA," Jones says.
“Sometimes balls get dropped because there’s lack of clarity as to who’s got the point,” Jones explains.
In its proposed reorganization, FDA has consolidated multiple points of entry for whistleblower complaints.
“I do think how you structure yourself can reduce the likelihood that a ball gets dropped, or somebody provides information to multiple sources and no one’s really quite sure who’s in charge of doing something with this,” Jones says.
The restructuring will better align FDA’s programmatic staff, who set policy, with inspectors in the field. This will allow a quicker response when a problem is identified, he says.
Also on Newsmakers, Roberta Wagner, International Dairy Foods Association senior vice president of regulatory and scientific affairs, says much of the agency’s reorganization focus has been on structural governance and leadership, but that FDA also needs to address its work culture.
For his part, Jones says that clarifying the leadership structure "will go a long way to helping address some of the cultural issues that have been ascribed to the organization previously."
Since the release of the Reagan-Udall Foundation report, Wagner says FDA has listened and engaged with stakeholders. “Kudos for stakeholder engagement and transparency," she says. "We’re hopeful that this becomes the new norm for the Human Foods Program and FDA as opposed to the exception.”
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Wagner says she hopes FDA “is a more action-oriented agency, an agency that makes decisions in a timely manner so that industry can innovate, grow and thrive and that also allows consumers access to affordable, nutritious and safe foods.”
Sarah Gallo, vice president of product policy at the Consumer Brands Association, adds this is a “once-in-a-generation shift” in how FDA considers its core missions as it relates to nutrition and chemical and food safety.
“That unified agenda with a unified leader where everybody’s rowing in the same direction is critical because that’s what’s going to allow us to get to food safety issues in a more timely fashion, allow innovation to meet consumer demand and allow our member companies to innovate and put new products in the marketplace that consumers are asking for, and again, to send that signal that we do have a safe food supply,” Gallo says.
Currently, the Department of Health and Human Services is reviewing FDA’s proposed plan before it goes to the Office of Management and Budget and House and Senate appropriations committees for review. FDA then will engage with its unions to finalize the reorganization. Jones anticipates the review process to be completed by 2024.
Gallo praised FDA for its aggressive timeline on implementing changes. Industry stakeholders will be watching carefully that the progress doesn’t halt or slow, she says.
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