Details on the Draft Senate FY 23 Funding Bill for FDA
Context. The draft Senate bills are considered placeholders. They appear to take account of some Republican priorities, but Republican have not agreed to spending levels or the balance between defense and non-defense spending. However, if there is any hope of appropriations bills passing the Senate in September, these draft bills are pivotal as responses to the House-passed funding bills.
Senate vs. House Top-line. The draft Agriculture/FDA Senate bill released this week would provide FDA with a $229 million (7%) increase in its FY 23 budget authority (BA) funding. This breaks down to a nearly $211 million increase in salaries and expenses (S&E) and an $18 million increase in buildings and facilities (B&F).
The House-passed FY 23 minibus funding bill would provide $3.645 billion in BA funding, an increase of $341 million (10%). and slightly more than the President’s Request.
Senate vs. House Priorities. A Senate summary document provides the following additional information: “Total discretionary funding for FDA $3.545 billion, an increase of $229 million over fiscal year 2022. Included in these increases are $43.5 million for food safety; $49.8 million for medical product safety; and $85 million for cross cutting activities. The bill also includes $5 million to implement the ALS ACT. In response to the current infant formula crisis, the bill also includes additional resources for maternal and infant formula health.”
The Senate Explanatory Statement detailing FDA provisions can be found here.
A House summary document provides the following additional information: “Within this total [of $3.645 billion], the Committee provides a targeted increase of $64 million for the opioid crisis, medical supply chain surveillance, drug safety surveillance and oversight, and increasing and strengthening in-person inspections of foreign drug manufacturers in India. It also includes a $77 million increase to better avoid or more quickly respond to food outbreaks, improve the animal food inspection system, and address heavy metals in baby food.”
Specific Program That Would Be Funded by the Draft Senate Bill. The Senate bill provides that “The Committee expects the FDA to continue all projects, activities, laboratories, and programs as included in fiscal year 2022 unless otherwise specified. The Committee provides a net increase of:
$34,000,000 for pay costs;
$22,050,000 for infrastructure;
$15,000,000 for Data Modernization and Enhanced Technology [DMET];
$7,000,000 for New Era for Smarter Food Safety;
$5,500,000 for Animal Food Safety Oversight;
$8,500,000 for Maternal and Infant Health;
$7,500,000 for Emerging Chemical and Toxicology Issues;
$2,000,000 for Standards of Identity;
$10,000,000 for Device Shortages and Supply Chain;
$800,000 for Medical Product Supply Chain;
$2,000,000 for Drug Safety Surveillance and Oversight;
$20,000,000 for Opioids;
$4,500,000 for Predictive Toxicology Roadmap;
$5,000,000 for DMET Medical Product Safety;
$2,500,000 for Premarket Animal Drug Review;
$5,000,000 for Medical Device Cybersecurity;
$20,000,000 for DMET Enterprise Wide;
$15,000,000 for Inspections;
$2,500,000 for Laboratory Safety;
$3,000,000 for the Office of the Chief Counsel;
$8,000,000 for Essential Services;
$2,500,000 for Reducing Animal Testing Methods;
$5,000,000 for ALS; and
$3,000,000 for Neurology Drug Program.”