President Donald Trump’s proposed budget could have wide ranging implications in virtually every industry. In the medical and food industries, the sweeping cuts could impact the implementation of new regulations and development of new research – which could ultimately impact product recalls.
The administration’s proposed budget would more than double fees collected by the Food and Drug Administration (FDA) to over $2 billion in 2018. That money would come from pharmaceutical and medical device companies submitting new products for review. The budget states that “in a constrained budget environment, industries that benefit from FDA’s approval can and should pay for their share.”
In what is referred to as a “complement” to this hike in fees, the budget also includes a now-familiar call for accelerating the approval process through what it calls a “package of administrative actions.” It also provides funding to implement the 21st Century CURES Act, which also aims to expedite approvals and fund new research. However, it calls for cuts to the Department of Health and Human Services (HHS) totaling nearly 18 percent, which many researchers believe could stall medical innovations.
In the food and beverage sector, the proposal calls for cutting the Department of Agriculture’s funding by 21 percent. However, it does not include a reduction to its Food Safety and Inspection Service.
While the proposal does not specifically mention the Food Safety Modernization Act (FSMA), as an HHS agency, cuts could have a widespread impact on the Food and Drug Administration, creating uncertainty even as FSMA implementation is underway. One day prior to the release of the proposed budget, a group of large food companies and associations delivered a joint letter to congress urging it to fully fund FSMA and pointing out that “substantial investments” have already been made “to ensure that FDA is on track” for implementation.
With no apparent direct cuts to existing food safety programs and differing recommendations on new medical advances that may be more vulnerable to recalls, it is unclear what – if any – immediate effect the cuts would have on recall preparation and execution. And it is important to remember that Congress ultimately controls the purse strings. But just as with every other aspect of business, it should be a key consideration for companies who are examining the potential impact.
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The FDA has announced a new Toolkit to combat counterfeits and other substandard medical products.… https://t.co/ifpjNuidD8
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