Earlier this month, the US Food and Drug Administration (FDA) requested $7.2 billion as part of President Biden’s 2024 budget. According to the FDA budget proposal, the agency wants $128.2 million of the $7.2 billion allocated for food safety programs. That means the FDA is requesting approximately 1.8 percent of its total budget for food safety.
The extent of the FDA’s problems is reflective of all the different responsibilities the vast agency has, ranging from control and supervision of food safety and cosmetics to pharmaceutical drugs and medical devices. But the agency has been under fire for the lack of a clear chain of command on the food side of its responsibilities as well as underfunding the food division, compared to the drug side of its operations.
With the FDA’s plate so full, some policymakers feel splitting off food safety into its own agency is the best way forward. Before examining the past proposals to separate and whether a separate food safety agency has potential, let’s look at the 2024 FDA budget and where it falls short in terms of food safety and regulations.
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2024 FDA Budget
A portion of the $128.2 million would go toward the food safety revisions outlined recently by FDA Commissioner Robert Califf. Califf has proposed changes that he says will help with response and prevention in food safety matters, but critics say his proposed deputy commissioner position lacks the authority to make a difference.
The FDA’s budget proposal also includes money to strengthen responses to shortages of critical foods, including baby formula. The baby formula crisis of 2022 — sparked by findings of Cronobacter sakazakii contamination in Michigan’s Abbott baby formula plant that manufactured Similac and other popular brands, and the subsequent recall and temporary closure of the plant — brought to light the agency’s lack of ability to respond to such crises.
Part of the $128.2 million request would also include:
- $10 million in investments in enterprise data and information technology (IT) modernization;
- $16 million for regulatory and mission support functions within the Office of the Commissioner; and
- $9.4 million for FDA buildings, facilities and infrastructure improvements.
Proposals for the food safety efforts of the agency include legislative efforts to boost the FDA’s authority to pursue food safety. This includes requiring the industry to test final food products marketed for consumption by infants and children for toxic elements and allowing the FDA to access those records.
Separate Food Safety from the FDA?
The latest proposal to split up the FDA is the Food Safety Administration Act, introduced by Senator Dick Durbin and Representative Rose DeLauro in July 2022. The bill would spin-off the FDA’s food-related responsibilities into a separate Food Safety Administration.
They argue that establishing a separate Food Safety Administration would improve food safety and benefit consumers by applying “focused leadership” from a food safety expert capable of providing more accountability. Additionally, the newly formed agency’s unified structure and direct oversight capabilities would ensure constant attention to food safety issues and more bandwidth to stay on top of foodborne illnesses.
In fact, policymakers have been discussing the separation of food safety from other FDA-regulated industries for years, or at least instituting reforms that would bolster the agency’s food safety responsibilities.
For example, some critics called for the FDA to be split into two agencies — one that handles drugs and medical devices and another that handles food safety and cosmetics — in the wake of a salmonella outbreak in 2008. Meanwhile, in 2010, the Obama administration established the new position of a deputy commissioner for foods and veterinary medicine to provide direct oversight on food issues. However, the Trump administration later took away the deputy commissioner’s authority over these units.
In June 2018, the Trump administration proposed a plan to consolidate the FDA’s food safety functions into a new agency within the US Department of Agriculture (USDA) known as the Federal Food Safety Agency. The FDA would have been renamed the Federal Drug Administration, but Congress would not extend him the power to reorganize the government.
Over the past ten years, the FDA’s budget for food has grown by 42 percent, while funding for the agency’s drug and medical device-related programs has increased 122 percent. This hasn’t always been the case. In 2008, the FDA budget sought $11 million for drug safety, $7 million for medical device safety and $10.6 million for food safety.
But until any serious reforms are made, the FDA will likely struggle to find a way to give the proper time and attention to its long list of food safety responsibilities.
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