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# FDA Budget Request Seeks $2.1 Billion Spending Boost
- URL: https://www.fdaweb.com/fda-budget-request-seeks-2-1-billion-spending-boost/
- Published: 2022-03-28T12:00:00.000Z
- Updated: 2026-09-14T17:38:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151464

FDA is requesting a $2.1 billion (34%) boost in its fiscal year (FY) 2023 proposed spending plan as part of President Biden’s just-released budget request. The proposed budget total would amount to $8.4 billion, which includes $3.7 billion in budget authority – an almost 10% increase of $356 million from the current authorized spending — and $3 billion in user fees – an increase of $153 million (5%). 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,” Commissioner **Robert Califf** is quoted in a [release](https://content.govdelivery.com/accounts/USFDA/bulletins/310d109?ref=fdaweb.com) as saying. “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.”

The $1.6 billion for pandemic preparedness would cover five years of increased spending and would allow FDA to modernize its regulatory capacity by strengthening its information technology and laboratory infrastructure. The agency says it will also help improve the evaluation of vaccines and therapeutics to respond to any future pandemic or high consequence biological threat, rapid development of diagnostics, and efforts to expand the personal protective equipment supply chain. Other notable budget items include:

- $24 million to toward improving inspections, such as 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.
- $5 million increase to improve medical device safety and security. The funding would help develop a more comprehensive device cybersecurity program.
- $20 million for FDA’s part in the Administration’s revamped Cancer Moonshot to speed progress in cancer research and improve cancer outcomes. The budget request would allow 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.
- $68 million in further investments in data modernization and enhanced technologies, such as artificial intelligence, and blockchain. Data modernization will also allow the agency to review large volumes of data more quickly to identify critical safety signals or emerging outbreaks.
- $5 million in additional funding to boost review capacity for premarket animal drug submissions.
- $30 million in additional funds to help end the opioid crisis. Funding will address 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.
- $5 million in new funding to develop a comprehensive strategy for new, alternative methods for product testing. It would fund FDA’s *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.

Additionally, FDA says the spending request also includes a “package of legislative proposals designed to bolster the FDA’s authorities to further its mission to protect and promote public health.” The proposals include those to: 

- Modernize dietary supplement regulation by requiring annual listing of individual dietary supplement products, including basic information about each unique product. It also would seek authorities over marketed dietary supplement products to improve enforcement against unlawfully marketed products.
- Enhance drug and biologic accelerated approval provisions to help ensure that the confirmatory studies will progress in a timely manner and provide high-quality, interpretable results. “This will help minimize the time that a product is marketed before its clinical benefit can be confirmed,” FDA says. “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 to allow the agency to approve subsequent generic drug applications unless and until a first applicant begins commercial marketing of a drug that would trigger the exclusivity period.
- Require the destruction of imported products by their owner or consignee that have been refused and pose a significant risk to public health.
- Assure a more resilient domestic supply chain for medical devices by requiring firms to provide notification of potential shortages with production volume information. In addition, it would require device manufacturers to perform risk assessments, implement risk management plans and identify alternate suppliers and manufacturing sites. FDA is also proposing the temporary importation of unapproved devices, with appropriate scientific and regulatory controls, when needed to prevent or mitigate a shortage.

Meanwhile, The Alliance for a Stronger FDA says it “endorses” the requested increase in FDA’s budget authority appropriations of about $356 million over the FY 2022 spending level. “We will be reviewing the detailed budget request to provide additional information about the strengths of the request and any areas in which we think additional emphasis is needed,” the group says.