— OPINION —
New York Times columnist Thomas Friedman once wrote; “Everything really important happens the morning after the morning after…”
In short, focus on what really changes, not what is said will change.
That is a good lesson for the White House and Congress to remember with the proposed “reforms” of the Food and Drug Administration’s (FDA) foods programs. Commissioner Robert Califf has promised that the structural, political, and cultural obstacles that have made FDA’s assurance of food safety ring hollow will be changed.
Food safety advocates across-the-board have their doubts. Consumer Reports’ food safety expert Brian Ronholm said the proposal “essentially cements the current dysfunctional structure at the FDA that led to the infant formula crisis and contributed to other longstanding problems that have plagued the agency.”
How dysfunctional was that structure that led to at least four infant hospitalizations and two deaths linked to tainted infant formula from an Abbott facility in Michigan? It took four months until the FDA would go into the plant to conduct a for-cause inspection months. A resulting, and much belated, recall then contributed to shelves empty of infant formula across the country, and parents of the richest country on the globe Googling DIY infant formulas.
Dr. Califf is in a long line of FDA commissioners trained in medicine with little to no experience in food safety. A cardiologist trained in clinical research, Califf is well versed in the risk/benefit approach to drug safety.
But for food safety, the approach needs to be different. Former President Barack Obama perhaps summed it up best in 2009 when he appointed FDA Commissioner Margaret Hamburg: “When we give our kids peanut butter and jelly, we don’t expect them to make them ill…No parent should have to worry that their child is going to get sick from lunch.”
And certainly, no parent should have to worry that their baby is going to get sick from infant formula.
When Dr. Califf testified before Congress during the infant formula crisis, he argued that, while serious systemic issues existed in the foods program, reorganization was not required. In eloquent managerial bureaucratic-speak, he said, “An optimal foods program organization must take into account the FDA’s product areas and centers are not silos, but a matrix of interdependent information and operations encompassing product and regulatory organizations and enterprise-wide support organizations.”
Maybe, he meant to say that unless and until there is a single food safety leader overseeing the entire foods program, consumers will remain at risk.
So, food safety advocates can be excused if that is not the change they see coming from the proposed reforms. It took the relentless and unified calls for reform from a broad coalition of FDA stakeholders, as well as the extensive investigative reporting by Helena Bottemiller Evich, that finally prompted the commissioner to have the Reagan-Udall Foundation conduct an independent review of the foods program that was chaired by former FDA Commissioner Jane Henney.
The panel’s conclusion? “The lack of a single clearly identified person to leads the human foods program has adversely impacted the organizational culture and led to overlapping roles and competing priorities that result in what is perceived as constant turmoil,” the review stated.
Precisely what the stakeholders have been telling the agency for years.
And the commissioner’s response, while promising change, delivers the same problems: A new “deputy commissioner” will be put in place, but once again not have authority over the agency’s food safety inspectors or laboratory staff as well as compliance and import oversight functions. While the commissioner said he is uniting the foods program, animal foods are left out despite the well-established principle that foods for animals and humans are inextricably linked.
As for when these “reforms” will actually happen, the most optimistic timetable is some time in 2024. The commissioner has stated the Department of Health and Human Services will not have a plan to review until late 2023, and he has also said publicly he is not certain of the support of employees and unions.
The morning after the morning after the proposed FDA food safety reform will not see much, if any, change.
That’s why it’s time for the White House and Congress to act: Create a new, independent federal Food Safety Agency. Then there really will be a morning after the morning after.
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