The federal government and many private businesses have learned some valuable lessons over the past several years. To keep up with the changing times and better respond to potential disruptions, organizations are making investments in modernization in addition to boosting initiatives for the future.
In March of this year, the U.S. Food and Drug Administration (FDA) announced that it had requested $7.2 billion for the 2024 national fiscal year budget. The budget authority will increase by $372 million due to this request, a 10% increase from the prior year. The agency aims to use funds to modernize its processes and capabilities for the coming years. Here’s what’s behind that request.
Improving Food Safety, Nutrition, and Cosmetics
The FDA is requesting $128.2 million in funding to go toward nutrition and food safety modernization. The programs will also focus on the oversight of animal food safety and food labeling.
The agency continues to define its vision for its Human Foods Program. At the same time, there is a substantial need for new programs to boost the agency’s nutrition and food safety capacity. The new budget aims to enhance consumer protection. It will also create long-term solutions for additional operational efficiency through ongoing investments in the New Era of Smarter Food Safety.
The budget seeks to build on what was learned from the supply chain troubles related to the infant formula shortage by including funding that will modernize oversight and improve response efforts when there are shortages of essential foods. These changes will help consumers gain access to healthier foods and reduce the potential for chemical toxins in the food supply.
The new budget is also structured to allow the FDA to remain competitive in terms of novel technologies and innovations being used to create ingredients for animal food. It will also help the agency address various oversight gaps in the animal food industry.
$5 million of the budget request will be allocated toward modernizing how the FDA oversees the cosmetics industry. For example, there will be funds for the creation of new regulations, product listing, and registration platforms, adverse event reporting, compliance policies, and other programs related to the proper labeling and safety of cosmetic products.
Enhancing Access to Effective and Safe Medical Products
The FDA is requesting $37.1 million to advance access to effective and safe medical products. It will be allocated as follows:
- $23.1 million in funds will be used to continue the battle related to the opioid epidemic. This funding will advance the development of various substance use disorder treatments and opioid overdose reversal, as well as expand compliance, regulatory oversight, laboratory support, and enforcement.
- $11.6 million in additional funds will go toward enhancing the supply chain for medical devices and various shortage programs. When there are supply chain issues of any kind, patients can get the medical care and devices they need. This funding will give the FDA the resources to advance its efforts in working proactively with healthcare providers, medical device makers, and supply chain partners to improve processes that will strengthen this critical supply chain.
- $2.5 million of this money will go toward the implementation of ACT for ALS, which will foster the development of treatments for ALS and other rare neurodegenerative diseases. These funds will allow the FDA to create new grants and related contracts and attract quality talent to work on these programs.
Strengthening Public Health and Mission Support Capacity
The FDA is requesting $35.4 million in funding to strengthen public health and mission support capacity. Those funds will be allocated as follows:
- $16 million in funds will be used to support regulation and mission functions by the Office of the Commissioner. This funding will allow the FDA to prioritize things like policy coordination, creating strategic direction for the agency, and enhancing business services that will ensure the FDA’s programs operate efficiently and effectively. The budget includes funds for improving data and technology management.
- $10 million will go toward IT and data modernization. The budget will help the agency significantly expand its resources to better meet its responsibilities and challenges. Some of its focuses will be related to identifying and addressing emerging trends and threats, such as outbreaks, adverse events, and recalls.
- $9.4 million in funding will be allocated to FDA facilities, buildings, and various infrastructure improvement projects. This will include funds to ensure the FDA’s laboratories and offices nationwide are modern, secure, cost-effective, and relatable to continue to protect the agency’s workforce and the American public.
Advancing Cancer Moonshot Goals
$50 million in new funding is in FY 2024 budget, earmarked for advancing the President’s Cancer Moonshot goals. This will include the expansion of collaborations and resources for new and innovative therapeutic and diagnostic products for the treatment of rare cancers and other initiatives to address cancer mortality and morbidity.
The budget will improve the agency’s efforts to help underrepresented populations in oncology clinical trials and provide support for the generation of new and useful data. It will also assist the FDA in expanding its efforts to achieve faster approval for cancer treatments that are showing promise in other countries.
Additional Legislative Proposals
The funding requests were also complemented by a package of legislative proposals designed to advance the FDA’s mission. These include things like expanding drug shortage notification requirements, broadening the FDA’s authority to request records in advance of inspections, and removing limitations requiring manufacturers to notify the FDA of discontinuances or interruptions in the manufacture of certain medical devices.
If approved, this additional funding will help the FDA build on its existing accomplishments and modernize its capabilities. These different initiatives will allow the agency to protect the public health and deliver oversight thanks to improved visibility throughout the system.