Maintaining things as they are? The FDA needs to make more changes.
One year after the scarcity of baby formula revealed significant structural and governance problems with the US Food and Drug Administration’s (FDA) Foods Program, the agency is facing yet another serious crisis: the inability to implement much-needed, drastic reform. The meals program’s severe shortcomings have not gone undetected, and it is evident that immediate action is required. However, significant reform is still lacking in the face of persistent, loud calls to address the major issues with the Food Program, and this comes at the expense of public health and safety.
In response to the problems highlighted by the scarcity of baby formula, the FDA declared last year that it was developing a proposal to restructure the Foods Program. Commissioner Robert Califf unveiled the original redesign proposal earlier this year, but it was harshly criticized for not making key significant changes that the agency sorely needed to improve the way it carried out its job on food safety. The Commissioner’s most recent public update on the redesign proposal revealed that, far from taking these concerns into consideration, he still wants to mainly maintain the existing quo.
Is a “specialized leader” necessary?
At the commissioner’s request, an independent panel of experts conducted an external evaluation prior to the announcement of FDA’s Foods Program reform plan. The final study demonstrated that by designating a fully capable, specialized leader or “Deputy Commissioner for Foods” with direct line responsibility over all significant elements of the Foods Program, immediate functional improvements could be achieved. The expert panel came to the conclusion that combining the functions of research, policymaking, inspection, and enforcement under a single food leader would increase functional efficiency and give the Foods Program’s budget the much-needed accountability it needs. This would be a radical structural shift that would allow for significant improvements.
Though Califf’s redesign plan includes some commendable revisions, it still falls short of reflecting the true spirit of the report’s recommendations. Although his strategy involves modernizing IT (information technology) business procedures, inspection workflows, compliance, and other regulatory activities, these improvements are not a replacement for the more radical changes that the Foods Program still requires.
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Rather, the Commissioner’s current plan doubles down by giving the agency’s next foods leader fewer administrative authority. His idea places main meals program components under distinct leaders who answer directly to the commissioner, rather than giving direct line control over all of them. This means that an astounding 60% of the Food Program’s budget would remain unmonitored for the next meals leader.
The Foods Program, as a unique component of the organization, should have a leadership model and organizational structure that are suited to its goals, not just enhanced in name. Such a fragmented organization has already proven to be ineffective, and permitting it to continue will not result in the complete transformation that the food program requires. Despite not having official authority over every aspect of the program, the FDA has made an effort to reassure us that the next Deputy Commissioner for Foods will make all of the financial decisions.Even if this is the true, the failure to provide complete direct line authority creates the possibility that, if the present commissioner steps down, things will resume as usual without warning. More immediately, this arrangement will make it more difficult for the FDA’s incoming head of food to provide funding authorizers in Congress with full budgetary transparency. In the end, this can discourage competent applicants from applying to take on the position.
Confusion-inducing reforms
We don’t know why the FDA ignored warnings regarding the dangers associated with the fragmented foods program structure. It is intolerable that the Commissioner isn’t actively pursuing more significant measures that adequately address the gravity of the current issue, a full year after the newborn formula crisis occurred. The FDA should prioritize preventing public health concerns over acknowledged structural weaknesses, and the present foods program redesign plan would make much-needed agency modernization extremely difficult to achieve. Nevertheless, consumers deserve an FDA that does everything within its power to avert such hazards.
Instead of dismissing important suggestions from prominent figures in the industry, impartial experts, Congressmen, and his own staff without providing a justification, we implore the Commissioner to undertake a really revolutionary meals program reform plan that will make a genuine and long-lasting difference. We require further information on the schedule for the remaining steps in the search for a new deputy commissioner for foods as well as details on how the redesign of the Foods Program will be implemented. It would be a disservice to consumers and the many FDA employees who have devoted their careers to promoting American health and safety if we miss this chance to make bold changes.