Still, Williams says, “Never say never.”
“I think if the FDA is supportive of it, Congress will likely align with whatever the FDA thinks is best, as long as it’s not costing them more money,” he adds. “However, the split could mean a more immediate need for an increase to the FDA’s budget, which some members of Congress would likely not support. I also think the push from big pharma and their powerhouse of lobbyists could help push this along. The pharmaceutical industry feels that they would be able to get drugs approved faster if the agency was split, which has a direct impact on a pharmaceutical company’s bottom line.”
Ronholm agrees and expects more dialogue on the idea to happen in 2022. And even if it doesn’t, the Reagan-Udall Foundation report revealed a lot of organizational failures that validated what many food safety experts have been saying for years, and he believes FDA will take many of the ideas for betterment into consideration, which would have a huge impact on food safety going forward.
Money Matters
Currently, nearly half of FDA’s budget is funded by user fees levied on industry members, and nearly all those user fees are drawn from drug, not food producers. Specifically, according to FDA, food regulation activities account for 18% of FDA’s budget, but only 1% of that funding comes from food industry user fees, while 65% of the funding comes from the drug industry. The rest comes from the Treasury.
Therefore, LaRae-Perez says that migrating food safety regulation to a new agency would require Congress to allocate much more than half of the current FDA Treasury funding to a new food safety agency, or the new food safety agency would have to start imposing significant user fees on food producers to fill the gap.
Many argue that the bigger and probably more important issue, which needs to be addressed whether the agency is split or not, is increasing FDA’s budget. “Currently, the FDA does not have the resources to inspect every food facility every two years as required by the FDA,” Williams says. “Realistically, this is done every three to five years. If the agency does get split, I think we need to understand the impact this could have on the FDA’s budget, as some shared resources may not be able to be shared anymore after the split. This could have a serious impact on both the food and drug industries, as well as consumers.”
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