FDA seeking significant budget increases to modernize and monitor public health
The U.S. Food and Drug Administration announced it is requesting a total budget of $8.4 billion as part of the President’s fiscal year (FY) 2023 budget – a nearly 34% ($2.1 billion) increase over the agency’s FY 2022 appropriated funding level for investments in critical public health modernization, core food safety and medical product safety programs and other vital public health infrastructure.
The request includes $3.7 billion in budget authority – including an increase of $356 million, and $3 billion in user fees – an increase of $153 million. The request also includes $1.6 billion in mandatory funding to support the FDA’s ability to prepare for future pandemics.
“The funding outlined in this year’s FDA budget request is critical to fulfilling the agency’s mission as we continue our work on a wide range of COVID-19 and non-COVID priorities. The FDA has focused our budget request on some of today’s most urgent needs such as human and animal food safety, medical device security and e-cigarette oversight. We also continue to look ahead at our role in public health, including at ways to modernize our efforts to keep pace with evolving science, technology and potential public health emergencies,” said FDA Commissioner Robert M. Califf, M.D. “Additional funding brings new ways to leverage opportunities to protect and advance the health of every American with reliable and science-based information. We look forward to continuing our work with Congress to help meet the critical public health challenges ahead.”
The FY 2023 request, which covers the period from Oct. 1, 2022, through Sept. 30, 2023, fully funds initiatives previously requested in the FY 2022 budget request and includes new efforts for high priority program areas. Highlights of the agency’s request include:
$1.6 billion over five years to support the FDA’s contributions to the HHS Pandemic Preparedness Plan. The FY 2023 Budget makes transformative investments in pandemic preparedness and biodefense across the U.S. Department of Health and Human Services’ public health agencies to enable an agile, coordinated and comprehensive public health response to future threats and protect American lives, families and the economy. This budget increase would allow the FDA to modernize its regulatory capacity by strengthening its IT and laboratory infrastructure. The agency will also focus on evaluation of vaccines and therapeutics to respond to any future pandemic or high consequence biological threat, facilitation of rapid development of diagnostics and work to support efforts to expand the personal protective equipment supply chain.
$43 million in additional investments in food safety modernization, including animal food safety oversight. The budget builds on the successes of human and animal food safety modernization activities and supports the agency’s continued implementation of the New Era of Smarter Food Safety and other core food safety efforts to enable the FDA to strengthen data-driven approaches to protecting consumers, allocating regulatory oversight resources based on risk and improving the FDA’s capacity to quickly respond to ongoing and evolving public health challenges. Building on the modernized food safety regulatory framework created by the FDA Food Safety Modernization Act, this funding will allow the agency to improve prevention-oriented food safety practices, strengthen data sharing and predictive analytics capabilities and enhance traceability to more quickly respond to outbreaks and recalls for human and animal food. The budget request advances mutual reliance efforts as part of the New Era of Smarter Food Safety by providing significant funding to state animal food programs. In partnership with states, the FDA will expand efforts to modernize, harmonize and transform the U.S. animal food inspection system to become more comprehensive and prevention oriented.
$14 million to improve health equity through nutrition. Through the Healthy and Safe Food for All initiative, the budget includes additional funding to reduce exposure to harmful chemicals and toxins in food. Additional funding and legislative proposals will focus specifically on better protecting mothers, infants and young children through contamination limits in food, product testing requirements, notification of anticipated significant interruptions in the supply of infant formula or essential medical foods, as well as modernization of dietary supplement regulation.
$20 million for the FDA’s efforts as part of Cancer Moonshot to speed progress in cancer research and improve cancer outcomes. The budget request provides a one-time infusion of funding to advance a variety of research, external collaborations and educational outreach programs and continue to support development and regulation of oncology medical products through the Oncology Center of Excellence. The agency will build upon existing programs to advance Moonshot goals.
$5 million increase toward improving the safety and security of medical devices. Developing a more comprehensive cybersecurity program for medical devices will help to identify and mitigate vulnerabilities that could compromise medical systems or disrupt device manufacturing or consumer use, placing national security at risk. Dedicated base funding for a cybersecurity program will allow for FDA to hire additional staff to recruit and develop greater cyber expertise within the devices program, as well as administer grants and contracts to develop infrastructure geared towards addressing emerging cybersecurity challenges.
$5 million in additional funding to boost review capacity for premarket animal drug submissions. Continuing to meet performance commitments, including reduced application review times for animal drug reviews, is a priority for the agency. The number of animal drug submissions received have steadily increased over time and therefore more effort is needed to review the additional submissions within agreed upon user fee timeframes and subsequently increasing the availability of safe and effective animal drug products.
$30 million in additional funds to advance the goal of ending the opioid crisis. Funding will address four priority areas of the epidemic including decreasing exposure and preventing new addiction, supporting the treatment of those with opioid use disorder, fostering the development of novel pain treatment therapies and improving enforcement and assessing benefit-risk.
$68 million in further investments in Data Modernization and Enhanced Technologies. The budget provides increases to core programs and infrastructure aligned to the food and medical product programs as well as critical enterprise technology capabilities. Data-informed capabilities, such as artificial intelligence, machine learning and state-of-the-art solutions like blockchain, will be critical to support the FDA’s public health priorities. Data modernization will also allow the FDA to review large volumes of data more quickly to identify critical safety signals or emerging outbreaks.
$100 million increase in user fees to support the FDA’s mission of reducing the use and harms of tobacco. The request includes funding to enhance the FDA’s ongoing oversight of e-cigarettes and other ENDS products, which remains a high priority and is critical to the agency’s public health mission, especially, to protecting kids from the dangers of nicotine addiction and other harmful health consequences. The budget proposes the additional user fees and requests authority to include manufacturers and importers of all deemed products among the tobacco product classes for which the FDA assesses tobacco user fees.
$24 million to optimize inspections and enhance inspectional capacity. The budget request increases support for the recruitment and training of new FDA investigators to improve the efficiency of the agency’s human and animal food and medical product inspectional operations. With additional personnel, as well as expanding the use of new and existing inspectional tools, the FDA will enhance its inspectional capacity and build on the efforts to keep pace with rapidly expanding industry including medical counter measures and advanced manufacturing.
$5 million in new funding for a comprehensive strategy for new, alternative methods for product testing. The budget includes funding to support a new, FDA-wide New Alternative Methods Program to reduce animal testing through the development of qualified alternative methods and spur the adoption of methods for regulatory use that can replace, reduce and refine animal testing. New alternative methods have the potential to provide both more timely and more predictive information to accelerate product development and enhance emergency preparedness.
To complement the funding requests the agency’s budget proposal also includes a package of legislative proposals designed to bolster the FDA’s authorities to further its mission to protect and promote public health. Notable proposals include efforts to:
Modernize dietary supplement regulation, seeking to require annual listing with the FDA of individual dietary supplement products, including basic information about each unique product. It is estimated the current supplement market is between 50,000 and 80,000 products. Additionally, the agency seeks to clarify its authorities over marketed dietary supplement products to better facilitate enforcement against unlawfully marketed products, allowing the FDA to know when new products are introduced, quickly identify dangerous or illegal products on the market and take appropriate action to protect consumers.
Require firms to notify the FDA of anticipated significant interruptions in the supply of infant formula or essential medical foods for patients with certain inborn errors of metabolism. This proposal would ensure the agency routinely receives timely and accurate information about likely or confirmed shortages in the U.S. and help the FDA to take steps to promote the continued availability of these foods. Additionally, the FDA is seeking authority to require firms to provide shortage notification for other FDA-designated categories of food during a declared public health emergency.
Enhance drug and biologic accelerated approval provisions to help ensure that the confirmatory studies will progress in a timely manner and reap high-quality, interpretable results. This will help minimize the time that a product is marketed before its clinical benefit can be confirmed. The FDA is also proposing a technical fix to revise the accelerated approval withdrawal standard.
Amend the Hatch-Waxman 180-day patent challenge exclusivity provisions, so that the FDA can approve subsequent generic drug applications unless and until a first applicant begins commercial marketing of a drug and triggers the exclusivity period, at which point approval of subsequent applications would be blocked by 180 days. This would ensure that the exclusivity only lasts 180 days, as intended, rather than multiple years. This would substantially increase the likelihood that generic versions of patent-protected drugs come into the market in a timely fashion and would allow multiple versions of generic products to be approved quickly leading to significant cost savings.
Require the destruction of imported products by their owner or consignee that have been refused and pose a significant risk to public health. The FDA believes this new authority would prevent the potential re-importation of these products and would deter owners and consignees from importing products they know to pose a significant public health risk. This authority could also increase efficiencies when Customs and Border Protection seizes an FDA-regulated product.
Assure a more resilient domestic supply chain for medical devices. This would include authority to require certain firms to provide notification of potential shortages with production volume information. In addition, it would establish a requirement for device manufacturers to perform risk assessments, implement risk management plans and identify alternate suppliers and manufacturing sites. The FDA is also proposing the temporary importation of unapproved devices, with appropriate scientific and regulatory controls, when needed to prevent or mitigate a shortage.
