FDA Gets $226 Million Spending Boost in Budget Bill

FDA’s fiscal year 2023 spending bill was signed into law 12/29/2022 as part of the end-year omnibus legislation (HR 2617, Consolidated Appropriations Act, 2023) that gives the agency a 6.5% boost ($226 million) above FY 2022 spending levels. In total, the measure provides FDA’s funding at $6.56 billion, which includes $3.03 billion coming from the agency’s user fee programs.

Under the spending bill, the funding increase allocated $43 million for medical product safety, $41 million for food safety activities, $21 million for infrastructure investments, and $121 million for cross cutting initiatives supporting both medical and food safety, according to a Congressional explanatory document. 

Within the increases for medical product safety, the bill includes $5 million for device shortages and supply chain activities; $800,000 for CVM medical product supply chain; $7 million to address the opioid crisis; $3 million for the agency’s Predictive Toxicology Roadmap; $5 million for its Data Modernization and Enhanced Technology Initiative; $1.5 million for foreign unannounced human drug inspection pilot programs; $5 million for the Orphan Products Grants Program; $5 million for premarket animal drug review workload; $1.5 million for drug safety surveillance and oversight; $5 million for medical device cybersecurity; $2 million for the neurology drug program; and $2 million for the Cancer Moonshot program.

The document also breaks down the increases for crosscutting agency-wide support initiatives, such as $71 million for payroll costs; $15 million for data modernization and enhanced technologies; $10 million for inspections; $2.5 million for the Office of Minority Health and Health Equity; $1.5 million for the Office of Laboratory Safety; $2.5 million for the Office of the Chief Counsel; $5 million for initiatives related to reducing animal testing through alternative methods; and $13.5 million for essential services.

The explanatory document also provides guidance to FDA on the following:

• It urges FDA to clarify the obligation of prescription drug and biological product sponsors regarding promotional activities.
• It supports FDA’s work to promote the domestic manufacturing of drug and biological products and urges the agency to increase efforts to encourage the pharmaceutical industry to adopt advanced manufacturing technologies that have the potential to improve product quality.
• It urges FDA to work with industry and the research community more broadly to continue enhancing its guidance and regulations concerning standardization of potency testing requirements for cellular therapies. This is intended to expedite the advancement of novel cellular therapies and accelerate delivery of medicines to patients with complex and unmet medical need.
• It encourages FDA to clarify the use of the accelerated approval pathway in expediting access to critical therapies for patients with cancer and certain rare diseases.
• It encourages FDA to organize clinical trials, in collaboration with academic medical centers and other federal agencies,
• It encourages FDA to work with the Type 1 diabetes community on the assessment of potential diabetes biomarkers related to islet autoimmunity.
• FDA should further invest in the science base for regulatory decisions on botanical dietary supplements, such as research to identify potential drug interactions with botanical drugs.
• FDA should provide a report to the Committees on Appropriations identifying applicants of INDs, NDAs, ANDAs, and BLAs that are headquartered in Russia.
• It encourages ongoing collaboration with patient stakeholders and the broad eczema community to address gaps and scientific knowledge and clarify the pathways for eczema therapies.
• It encourages FDA to facilitate innovative and flexible regulatory approaches to allow for genetically targeted platform technologies, gene expression biomarkers, novel statistical approaches, external controls and a benefit-risk approach to evaluating manufacturing process requirement
• It urges FDA to develop policies and guidances that keep pace with scientific discovery for the prevention and early detection of neurological disease.
• It encourages FDA to establish a pilot program that will apply new tools to improve generic drug development, manufacturing, and quality.

In advance of the bill’s signing, the Alliance for a Stronger FDA thanked Congressional appropriators for their continued support of the agency. “The Alliance remains committed to working with appropriators and the commissioner to assure that these additional funds are used appropriately and to the benefit of the American people,” the group said in a statement. “FDA’s mission continues to grow, and its vital activities have become more complex and require greater sophistication and expertise. The agency needs an increased budget, more scientific and technical staff, and better analytical tools that support science-based decision-making and keep up with innovation in food and drug safety, and food, veterinary and medical products.”