Alliance thanks Appropriators for FY23’ Plans for FY24

FDA’s FY 23 Appropriation Increases BA Funding by $226 Million

• Alliance Thanks Appropriators for Support; Releases Information About Omnibus

• Alliance Builds Support for Further Increases in FY 24

• First Alliance Webinar of 2023

• CY23 Invoices Sent to Alliance Members

• Upcoming Publication Schedule for Friday Update

This week’s Analysis and Commentary answers questions about 21st Century Cures monies; ascertaining funding levels for specific programs; the status of provisions contained in House report language; the rationale behind monies for increased personnel costs; the relationship between the FY 23 omnibus and food safety reform; and other FDA-related provisions in the Omnibus.
 
FDA’s FY 23 Appropriation Increases BA Funding by $226 Million.Congress is on a path to adopt the Consolidated Appropriations Act of FY 2023 (the Omnibus), which in part funds FDA (Details start on page 47 of the Explanatory Statement found here.). The result: an addition of $226 million in budget authority (BA) funding (more than a 6.5% increase) to meet FDA’s needs and strengthen programs throughout the agency.
 
President Biden is expected to sign this bill into law following completion of Congressional action. Another short-term CR through December 30 has also been passed by the Senate and is expected to be approved by the House to provide the time needed to review and enroll the final bill once House action is completed.

The legislation provides a net increase of $226 million in FDA’s FY 23 BA authority. Of this, $43 million is for medical product safety; $41 million is for food safety activities;  $121 million is for cross cutting initiatives supporting both medical and food safety, and $21 million for infrastructure investments. Specific allotments are described in the Explanatory Statement, which is excerpted in the Alliance’s media release.

For medical products safety, the legislation “provides targeted increases to address the opioid crisis, medical supply chain issues, cybersecurity of medical devices, and increasing and strengthening in person inspections of foreign drug manufacturers.” For food safety, the legislation provides monies “to better avoid or more quickly respond to food outbreaks, improve the animal food inspection system, and address heavy metals in baby food.”
 
Within the increases for crosscutting Agency-wide support initiatives, the legislation provides monies to support pay costs and essential services; data modernization and enhanced technologies; inspections; minority health; laboratory safety, and reduction in animal testing through alternative means.

Alliance Thanks Appropriators for Support; Releases Information About Omnibus. In a statement to the media, the Alliance thanked Congressional appropriators for their continued support of the FDA  It added that “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.”

This release also contains 1/ text from the House Executive Summary and Explanatory Statement, and 2/ a chart constructed by the Alliance that shows growth by center for FY 23 compared to the FY 22 base.

Alliance Builds Support for Further Increases in FY24. Looking ahead to FY 24 appropriations, the Alliance’s statement provided the rationale:  “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.

We believe a growing mission requires a growing budget. The American people are the beneficiaries of continued investment in the agency."

First Alliance Webinar of 2023. The Alliance will have its first webinar of 2023….January 13 at 11:30 a.m. with:  Andi Fristedt, FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs. More details to follow, but you can register here now.

CY23 Invoices Sent to Alliance Members.Please keep an eye out for your invoice for Alliance 2023 dues. Please let Elisa know if you have not received an invoice or cannot find it.

Upcoming Publication Schedule for Friday Update.Today’s special edition—December 23, 2022—is the last scheduled Friday Update for this year. We will restart weekly editions on January 6, 2023.