Califf Slated for Senate Hearing

2023 Alliance Webinar Series: Center Directors Discuss Their FY 24 Budget Requests. We have further upgraded our webinar series in 2023, with more programs and a broader range of FDA speakers.

We have six more programs planned—all intended to help FDA stakeholders to become more knowledgeable about the President’s FY24 Request and the priorities within each Center.

First up, next week, we will hear from Dr. Jeff Shuren, Director of FDA’s Center for Devices and Radiation Health (CDRH)

Over the three weeks, we will hear from all 5 Center directors and the head of the Office of Regulatory Affairs. While the topic is the FY 24 budget, in past years there have been a lot of updates and announcements about program initiatives:

3/23     Dr. Shuren, CDRH                  11:00   Shuren event registration

3/29     Ms. McMeekin, ORA               2:30   McMeekin event registration

3/31     Dr. Mayne, CFSAN                11:00   Mayne event registration

4/04     Dr. Marks, CBER                     3:30   Marks event registration

4/05     Dr. Cavazzoni, CDER              2:00   Cavazzoni event registration

4/10     Ms. Forfa, CVM                       3:00   Forfa event registration

The Alliance has already this year held four programs including with the Commissioner, the Principal Deputy Commissioner, and the Deputy Commissioner for Policy, Legislation, and International Affairs. Transcripts are available for each.

1/15      Andi Fristedt                            Legislation and Policy   Transcript

2/10      Dr. Robert Califf                       State of the Agency       Transcript

2/15      Elizabeth Hillebrenner                Diagnostics                    Transcript

3/2       Dr. Janet Woodcock                  Food Programs               Transcript

House Deadline for Submission of Testimony is April 10. There is the opportunity to submit testimony in the House, with a due date of April 10, 2023. Accordingly, the Alliance encourages all members to submit testimony to the House in support of the Alliance “ask” for FY 24 FDA funding. The Alliance’s main message is that a growing agency (FDA) requires a budget that grows. The case for this is stronger if Alliance members tell Congress why more resources are necessary.

The House Subcommittee has provided explicit directions about formatting and other submission details (here). The best testimony intermixes broader points about FDA funding needs with specific examples of how a well-funded FDA advances programs that affect you or your organization. Alliance staff welcomes requests for assistance in preparing testimony in support of FDA funding.
 

Senate Appropriations Committee Announces FDA Hearing on April 19 – Senate Appropriations Chair Patty Murray and Ranking Member Susan Collins have released a tentative hearing schedule for the Subcommittees of the Senate Appropriations Committee.  According to this tentative schedule, FDA and Commissioner Califf are expected to present FDA’s budget request to the Agriculture/FDA Subcommittee  on Wednesday, April 19, at 2:30 p.m.

Balancing the Federal Budget Would Require Drastic Spending Cuts Over the Next Ten Years. As reported by The Hill (here), the Congressional Budget Office (CBO)’s analysis of plans to eliminate the annual budget deficit in 10 years found the task daunting.

If legislators exclude Social Security—as both parties have promised—balancing the budget could require cutting 41 percent of spending on other programs aside from interest outlays. The percentage rises to 57 percent if Congress takes Medicare off the table as well, and then 86 percent if defense discretionary programs, and mandatory veterans’ programs are additionally factored out. If the expiring portions of the Trump tax cuts were to be extended, then all of these percentages would be higher.

Advance Manufacturing Needs Clearer Rules: Reports from GAO and USP. As reported in RAPS Focus (here), the Government Accountability Office (GAO) and the United States Pharmacopeia (USP) asserted in two recent reports that the regulators need to address some of the ambiguities associated with advanced manufacturing to accelerate adoption in the pharmaceutical industry. The GAO further recommended that the US Food and Drug Administration (FDA) should set benchmarks to better measure uptake to this mode of manufacturing.

According to one commentator, the  GAO report offers a more comprehensive look at advanced manufacturing while the USP’s report explores supply chain preparedness and ensuring a quality supply of antimicrobials for combatting antimicrobial resistance. Both reports cite regulatory challenges as obstacles for companies to invest in advanced manufacturing.

Woodcock Transcript Available on Alliance Website. On March 3, 2023, the Alliance for a Stronger FDA hosted a webinar with Dr. Janet Woodcock to discuss emerging changes in food programs at the FDA. A transcript of that conversation is available here.