Commissioner Califf to Address Alliance for a Stronger FDA: July 12 from 1:30 to 2:30.
Top-Line:
Commissioner Califf to Address Alliance for a Stronger FDA: July 12 from 1:30 to 2:30. Registration open.
House Appropriations Committee Advances Ag/FDA Funding Bill with 10% Increase for FDA.
House Appropriations Committee Report Covers Dozens of Issues.
Alliance for a Stronger FDA Supports House Mark.
House Provides Subcommittee Allocations with 8.3% Increase for Ag/FDA Bill.
FDA Makes Progress on Drug Shortages in 2021.
Alliance Unveils New Website: www.strengthenfda.org.
This week’s Analysis and Commentary discusses the need for appropriate FDA funding, staffing needs across FDA offices, and the need for FDA-devoted resources with the implementation of ARPA-H.
Commissioner Califf to Address Alliance for a Stronger FDA: July 12 from 1:30 to 2:30. Dr. Califf will address FDA’s mission and resource needs as part of a fireside chat with the Alliance. The event will be Tuesday, July 12 from 1:30 to 2:30 p.m. ET and will be open to Alliance members and media. Please register here.
The Alliance welcomes guests at our events. If you are not an Alliance member and would like to attend, please contact Alliance Executive Director, Steven Grossman.
House Appropriations Committee Advances Ag/FDA Funding BIll with 10% Increase for FDA. The House Appropriations Committee marked up the Ag/FDA funding bill on June 23, 2022, passing it by a vote of 31-26. Under the bill, BA (budget authority) funding would reach $3.645 billion, an increase of $341 million (10%) and slightly more than the President’s Request.
Floor consideration of appropriations bills is projected for July. Senate dates have not yet been announced. If the Senate follows prior years, their mark-ups will occur in July.
House Appropriations Committee Report Covers Dozens of Issues. The FDA report language in the FY 23 House bill runs twenty pages and includes items of interest to dozens of FDA stakeholders.
The first item in the report expresses concerns about the understaffing of small, key offices. This topic is explored in this week’s Analysis and Commentary (below).
Alliance for a Stronger FDA Supports House Mark. The Alliance released the following statement:
"The Alliance for a Stronger FDA is appreciative and fully supportive of the FY23 FDA funding proposed in the subcommittee bill. We applaud the leadership of Subcommittee Chair Sanford Bishop (D-MD) and Ranking Member Andy Harris (R-MD).
As reported in the subcommittee summary, FDA would receive a total of $3.645 billion in discretionary (budget authority) funding in the bill. This is an increase of $341 million (10%) above the FY 2022 enacted level.
The proposed increase is in line with the Alliance’s “ask” for FY 23 BA funding for FDA and is, reportedly, slightly larger than the President’s Budget Request.
As more detailed budget tables become available, we will provide policymakers, media, and FDA stakeholders with additional analysis."
House Provides Subcommittee Allocations with 8.3% Increase for Ag/FDA Bill. Without a bipartisan and bicameral agreement on total FY 23 federal discretionary spending, neither the House nor the Senate can tell appropriations subcommittees how much they will they be able to appropriate.
To move forward in the meantime, the House adopted a deeming resolution that sets total spending at a certain level. The subcommittee allocations within that total have been released and the Ag/FDA subcommittee has been given an 8.3% increase over the FY 22 funding levels. The higher allocation is what helps allow for the increase in FDA and other programs. See the 302 b comparisons here.
FDA Makes Progress on Drug Shortages in 2021. As reported by Regulatory Focus (here), 317 drug shortages were prevented by the FDA in 2021, the highest since the agency began tracking shortages in 2012. This reflects agency reliance on regulatory flexibility, determining if other manufacturers can take over production, and ensuring inspections and facility reviews are completed quickly.
Alliance Unveils New Website: www.strengthenfda.org. The new site is content-rich and our goal, over time, is to make it even more useful. Please let us know if you have ideas about content related to FDA’s funding, mission, and responsibilities that you think would be valuable to Alliance members, policymakers, media, FDA stakeholders, and the public.
