Food safety was called out this year as the step-child at Food and Drug Administration. And the FDA Commissioner who called for an outside review by Reagan-Udall Foundation did not seem to doubt there are leadership and organizational problems. The Foundation’s report also seemed to lay everything on the table.
Congress is responding too, with more money for food safety and more overall for FDA. In the just-released omnibus bill covering FY 23 appropriations funding, FDA gets an additional $226 million in budget authority (BA) funding, which is more than a 6.5 percent increase.
The omnibus funding bill is expected to be on the Senate floor by today (Wednesday) and should reach the House on Thursday or Friday. It is expected to pass both bodies and be signed by the President before the current Continuing Resolution expires at midnight on December 23, 2022.
The source for this late-breaking budget information is The Alliance for a Stronger FDA, a stakeholder organization with 150+ members devoted to advocating for increased appropriations for the FDA and educating policymakers and the public about the FDA’s mission and responsibilities.
“FDA’s mission continues to grow, and its vital activities have become more complex and require greater sophistication and expertise” according to the Alliance. “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.”
The Alliance reports that The agreement provides $3,530,150,000 in discretionary budget authority and $3,032,643,000 in definite user fees for a total of $6,562,793,000 for FDA, Salaries, and Expenses.
This total does not include permanent, indefinite user fees for the Mammography Quality Standards Act; Color Certification; Export Certification; Priority Review Vouchers for Pediatric Disease; Food and Feed Recall; Food Reinspection; Voluntary Qualified Importer Program; the Third Party Auditor Program; Outsourcing Facility; and Over-the-Counter Monograph.
The agreement expects FDA to continue all programs, projects, activities, and laboratories, as included in the fiscal year 2022 unless otherwise specified, and maintain the $1,500,000 transfer to the Health and Human Services Inspector General for its audit and oversight work involving FDA.
The agreement provides a net increase of $226,005,000, of which $42,800,000 is for medical product safety, $41,000,000 is for food safety activities, $121,122,000 is for cross-cutting initiatives supporting both medical and food safety, and $21,083,000 is for infrastructure investments.
Within the increases provided for medical product safety, the agreement includes $5,000,000 for Device Shortages and Supply Chain; $800,000 for CVM Medical Product Supply Chain; $7,000,000 for Advancing the Goal of Ending the Opioid Crisis, including support for interagency activities to combat the illicit importation of opioids, including fentanyl, through international mail facilities and land ports-of-entry; $3,000,000 for the Predictive Toxicology Roadmap; $5,000,000 for the Data Modernization and Enhanced Technology Initiative; $1,500,000 for Foreign Unannounced Human Drug Inspection Pilots; $5,000,000 for the Orphan Products Grants Program to implement Act for ALS; $5,000,000 for Premarket Animal Drug Review Workload; $1,500,000 for Drug Safety Surveillance and Oversight; $5,000,000 for Medical Device Cybersecurity; $2,000,000 for the neurology drug program; and $2,000,000 for Cancer Moonshot.
Within the increases provided for food safety activities, the agreement provides $10,000,000 for Maternal and Infant Health and Nutrition; $8,000,000 for Emerging Chemical and Toxicology Issues; $20,000,000 for New Era of Smarter Food Safety; $1,000,000 for machine learning; $1,000,000 for sodium reduction targets; and $1,000,000 for Standards of Identity.
Within the increases for crosscutting Agency-wide support initiatives, the agreement provides $71,092,000 for Pay Costs; $15,000,000 for Data Modernization and Enhanced Technologies; $10,000,000 for Inspections; $2,500,000 for the Office of Minority Health and Health Equity; $1,500,000 for the Office of Laboratory Safety; $2,500,000 for the Office of the Chief Counsel; $5,000,000 for Reduce Animal Testing through Alternative Methods; and $13,530,000 for Essential Services.
The year is ending with FDA getting an inflation-fighting boost for food safety, not the reorganization or shake-up many were expecting. The outside foundation report still gives FDA Commissioner Robert Califf all the backing he needs should he decide in 2023 to put a single deputy in charge of food.
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