In March 2022, United States President Joe Biden released his budget request for Fiscal Year 2023, which included a significant boost for the United States Food and Drug Administration (FDA) – an increase of 34%, or $2.1 billion. The FDA notes that the FY 2023 request “fully funds initiatives previously requested in the FY 2022 budget request and includes new efforts for high priority program areas.”
That majority of those new funds are to be directed at preparing for the next potential pandemic, including the next iteration of the current COVID-19 pandemic. Biden requested $81.7 billion in 2023 pandemic funds for the entire Department of Health and Human Services (HHS) with $1.6 billion going to the FDA so that the agency can expand and modernize pandemic-related regulatory capacity, technology, and lab infrastructure.
The budget includes an additional $54 million to be spent on capacity-building efforts at the agency, including support for essential services, such as responding to inquiries and subject matter expertise on FOIA requests, legal services, and support efforts that reduce risk from laboratory work, enhance laboratory security and data quality, and increase efficiencies across the safety and health program.
President Biden’s budget request also includes $34 million over last year’s budget to partially fund some of the anticipated increases in payroll for FDA’s employees.
FDA Budgetary Requests
The FDA sought $20 million for the FDA’s efforts in the Cancer Moonshot program to speed progress in cancer research and improving cancer outcomes. The $20 million is a one-time fund to support programs that incorporate patient voice, real-world evidence, and collaborations with FDA’s global partners to facilitate faster patient access to new cancer therapies.
An additional $30 million next year will also go to helping the opioid crisis, with funds helping 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.
The FDA also requested a $5 million increase toward improving the safety and security of medical devices. The agency believes that by developing a more comprehensive cybersecurity program for medical devices, it will better be able to identify and mitigate vulnerabilities that could compromise medical systems or disrupt device manufacturing or consumer use, placing national security at risk. Plus, 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.
FDA Congressional Requests
When it comes to Congressional requests made by the Agency, the FDA sent Congress a package of legislative proposals “designed to bolster the FDA’s authorities” — notable proposals mentioned include accelerated approval reforms to help ensure that the required confirmatory studies will finish in a timely manner and “reap high-quality, interpretable results” which will reduce the time that a product is marketed before its clinical benefit can be confirmed.
The FDA is also looking to Congress to revise the Food, Drug, and Cosmetics Act to allow the agency to require that a sponsor first demonstrate that a proposed confirmatory study is adequately designed to verify and describe clinical benefit and can be completed in a timely manner before as a condition of an accelerated approval application’s acceptance for filing or approval.
The FDA would also like to revise the law so that it can follow its typical dispute resolution procedures for drug applications when withdrawing an accelerated approval. FDA is also proposing a technical fix to revise the withdrawal standard so that it mirrors the analogous withdrawal standard set forth in section 505(e) for drugs with traditional approvals.