Alliance Hill Days Announced & Dr. Shuren Transcript Available

Alliance Virtual Hill Days Announced—April 25 and 26.  Each Spring the Alliance for a Stronger FDA reaches out to Hill offices to emphasize our support for robust FDA appropriated resources.
 
Our first two days will be Tuesday, April 25 and Wednesday, April 26 and will be virtual.As veterans of this process will recall, we would like to have a broad cross section of our membership participate which helps illustrate the breadth of FDA’s work and its central role in public health and our economy.
 
Alliance members are asked to check their calendars and let Ben Dash know your availability on those two days. This promises to be a challenging appropriations cycle and your voice is important. More details are contained in this week’s Analysis and Commentary.
 
Commissioner Califf Testifies Before House Appropriations Subcommittee on FDA’s FY 2024 Budget Request. On Wednesday, March 29, the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held its hearing on the FY 2024 Budget Request for the Food and Drug Administration. Commissioner Robert Califf was the only witness at this hearing.  
 
In his opening remarks, new Subcommittee Chairman Andy Harris (R-MD) said that the Administration’s budget request is “make believe” while there is a need to rein in spending.   He said the total FDA budget request is an 8% increase over FY 2023, and the budget authority portion itself is a 10% increase.  He also said the BA increase since 2018 is 25%.  He called for a better utilization of existing resources, and more transparency in how funds are spent.   
 
Subcommittee Ranking Member Sanford Bishop (D-GA) and Full Committee Ranking Member Rosa DeLauro (D-CT) both expressed concerns about what the impact will be on food and drug safety if appropriations are provided at only the FY 2022 level, as some have suggested.
 
The hearing covered a wide range of topics, including concerns about the restructuring of FDA food programs, continuing issues involving infant formula, FDA’s work with state agencies, unannounced foreign inspections, pediatric cancer, the proposed rule regarding food traceability, supporting domestic production of drugs and food items, cell cultured foods, and other matters.
 
Subcommittee Chairman Andy Harris’ opening statement is here. Subcommittee Ranking Member Sanford Bishop’s (D-GA) statement is here. Full Committee Ranking Member Rosa DeLauro’s statement is here. Commissioner Califf’s statement for the record can be found here. 
 
The video of the hearing can be found here. Scroll to the 9:30 mark where the hearing begins.
 
Commissioner Califf is scheduled to testify before the Senate Subcommittee on April 19.
 
Testimony Deadlines: Senate on March 31; House on April 10. The Alliance encourages all members to submit testimony that makes a general case for FDA funding (“FDA’s growing responsibilities requires a budget that grows”) and talks specifically about the impact of a well-funded FDA on your organization and its members.

The Senate Ag/FDA Subcommittee testimony is due March 31 (later today). Here are the explicit directions about formatting and other submission details (here). The House Ag/FDA Subcommittee testimony is due April 10. Here are explicit directions about formatting and other submission details (here).

Contact Roger Szemraj if you need our help.  
 
Summary and Transcript for March 23 Webinar with CDRH Director Jeff Shuren. On March 23, the Alliance held a webinar with CDRH Director Dr. Jeff Shuren. He focused his remarks on the FY 24 budget request and also discussed progress on a number of program initiatives.

A summary of his remarks is here. A transcript of his remarks is here. He also announced the then-pending release of “Transition Plan for  Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency'' (FDA notice here and the guidance here).

2023 Alliance Webinar Series: Center Directors Discuss Their FY 24 Budget Requests.

3/31     Dr. Susan Mayne, CFSAN               11:00  Mayne event registration
4/04     Dr. Peter Marks, CBER                    3:30    Marks event registration
4/05     Dr. Patrizia Cavazzoni, CDER         2:00    Cavazzoni event registration
4/10     Ms. Tracey Forfa, CVM                    3:00    Forfa event registration
4/14     Ms. Judith McMeekin, ORA             1:00    McMeekin event registration

CFSAN Director Susan Mayne Retiring, Effective May 31. As CFSAN Director over the last eight years, Dr. Mayne highlighted her accomplishments by reference to:

“...great progress on the Food Safety Modernization Act (FSMA), issuing 9 rules and almost 70 guidances since 2015. We continue this work through a series of prevention strategies. These tremendous efforts exemplify the prevention of foodborne illness at its best….

In the nutrition space, the policies put in place over the last 8+ years are arguably some of the most impactful ever to come out of FDA….[by] empowering consumers with information and working to create a healthier food supply for all, policies that are being emulated across the globe.  This work will further empower consumers and have an impact on public health.”

A news story on her retirement can be found here.