According to the U.S. Food and Drug Administration (FDA), $8.4 billion has been requested for the 2023 fiscal year budget. Although the amount is about 34% over their 2023 level of appropriated funding, the announcement comes as no real surprise coming on the heels of the COVID pandemic.
What is the FDA?
While most Americans are familiar with the FDA, many don’t completely understand what the agency’s job is. The FDA is an organization within the U.S. Department of Health and Human Services that is charged with protecting the public by ensuring their safety through testing and regulating vaccines, veterinary drugs, medical devices, and biological products for human use. They are also in charge of the security and safety of the nation’s dietary supplements, food supply, cosmetics, tobacco products, and products that emit electronic radiation. Being a national agency, they are required to submit a projected budget request for the upcoming year which they have to the tune of $8.4 billion.
Why the Big Budget?
It’s not unusual for a national agency to request a huge sum for their budget for no good apparent reason so the fact that the FDA is asking for a large increase is definitely not out of line following a global pandemic. The proposal includes a $336 million increase, and $3 billion in user fees for an escalation of $153 million, according to the FDA. Also in the mix is $1.6 billion in mandatory funding to support the FDA’s capacity for pandemic preparedness.
What Exactly is Included in the Budget?
There are multiple levels of expenditure that is being proposed for the 2023 budget including:
Cancer Research and Improvements
$20 million has been earmarked for efforts to combat cancer via the program “Cancer Moonshot” which is in place to speed up cancer treatment and research progress and to improve the outcomes. Also on the list is the allocation for one-time filtration of funding with the purpose of advancing various research, extending educational outreach programs, and creation and development of external collaborations. The support and development of medical products through the Oncology Center of Excellence to build upon existing programs and to advance Moonshot goals is part of the plan as well.
Safety and Security of Medical Devices
An escalation of $5 million for the improvement of the safety and security of medical devices is one of the top priorities. With the recent global pandemic having exposed some shortcomings in the current system, the need for increased cybersecurity for medical devices is evident to prevent the possibility for the disruption of device manufacturing and other medical system vulnerabilities. Grants will be given, and contracts granted which will address rising cybersecurity challenges.
Animal Drug Submissions
The safety of animal drugs is at stake due to the length of time it takes to test submitted drugs and the long process of getting them approved. Since animal drug products also affects humans, the need to expedite the process is of great concern. Additional funding in this line is set for $5 million.
Close to 50,000 people die each year from opioid overdose. More than 10 million individuals abuse opioids annually. In an effort to find solutions, $30 million of additional funding will be used to end the crisis.
Another area to be addressed in the budget is reducing the use and harm of tobacco and tobacco products, including e-cigs. The FDA is asking for $100 million to further efforts.
For the HHS Pandemic Preparedness Plan, $1.6 billion has been requested. The funds will be allocated over the course of a five-year period. They will be used to enable and coordinate a comprehensive public health plan to protect American lives as well as the economy in the event of a future pandemic. Strengthening IT and laboratory infrastructure is a main focus. Evaluation of vaccines and therapeutics in response to a pandemic threat is also a key component which includes facilitation of rapid development, diagnostic work and PPE supply chain expansion.
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Data Modernization and Enhanced Technologies
Funding of $68 million has been requested for programs and infrastructure that deals with medical product programs and the capabilities of critical enterprise technologies. Artificial intelligence, state-of-the-art solutions (such as blockchain technology), and training in machine learning are some of the arenas the funding will funnel.
Expedited Inspection and New Product Testing
Especially during a time of medical crisis such as a pandemic, it is imperative that products be tested with haste. The proposal for $5 million in new funding for comprehensive strategies to expedite new product testing will expand so they can keep up with rapidly expanding medical product needs. $24 million is intended to enhance inspection capacity and optimize inspections.
Food Safety and Nutrition
Additional investments totally $43 million are allotted for food safety modernization. This proposal involves animal food safety oversight, supporting a continued effort to promote and perfect data-driven protection for consumers. Improving the response to outbreaks and recalls of food products is also on the agenda. Transforming and modernizing U.S. animal food inspection has also been cited as a chief focus.
Nutrition awareness is up for $14 million. Reduction of exposure to harmful toxins and chemicals in food, better nutrition for infants, young children, and expectant mothers, and addressing interruption in infant formula will be subjects of concern that will be tended to in this area.
Breaking it All Down
The FDA has big plans and a big requested budget to manage it. Whether you are in the medical field, are a developer, or are a citizen who will reap the benefits of a medically safer society, what it all boils down to is that the budget is astronomical but in the long run, so are the benefits.