FDA Before Senate Appropriations on Wednesday, May 8
Register for the last two programs in the Alliance’s Annual Budget Series.
CDER Director Dr, Patrizia Cavazzoni on Monday, May 6 at 2:30 pm. Register here.
CDRH Director Dr. Jeff Shuren on Tuesday, May 14 at 2 pm. Register here.
This week’s Analysis and Commentary is entitled “Q&A on the Urgent Need for FDA Advocacy.”
FDA Before Senate Appropriations on Wednesday, May 8. Commissioner Califf will appear before the Senate Agriculture/FDA Appropriations Subcommittee on Wednesday, May 8 at 10:00 regarding FDA’s FY 25 budget request.
A link to the upcoming hearing can be found here. This provides the capability for the public to hear the testimony live.
Submission of Outside Witness Statements for the Record: House and Senate Subcommittee Deadlines Are Next Week. Each year the Alliance submits a statement for the record detailing our rationale for FDA funding. The Senate Agriculture/FDA Subcommittee has now set Wednesday, May 8 for its deadline, while the House Subcommittee has set May 10.
Here you will find an advance copy of the testimony that we will be submitting to the Senate Appropriations Subcommittee by its May 8 deadline.
We encourage our members to submit testimony on behalf of their own organizations to help bolster support for the FDA. It can mirror our testimony or pick up on one or more funding priorities that are described in our testimony.
Instructions for submitting testimony to the Senate Subcommittee can be found here.
Instructions for submitting testimony to the House Subcommittee can be found here.
Please note that the instructions are different.
If you have any questions, please contact Roger Szemraj.
Alliance Members Urged to Participate in Upcoming Hill Days. A strong number of House and Senate offices have agreed to in-person meetings with the Alliance. House offices will be on May 7 and 8, and Senate offices on May 15 and 16.
We strongly encourage Alliance members to join us for these visits. Please let Ben Dash know of your availability for any of these days, particularly for May 15 and 16. Non-members interested in participating should contact Steven Grossman.
The Alliance’s Hill Days are an opportunity to advocate for a strong, well-funded FDA and educate Congress about FDA’s expanding mission and growing responsibilities.
Broad participation from every stakeholder group and member organization strongly reinforces our unity about FDA’s funding needs and our commitment to two messages: “a strong FDA benefits all Americans” and “FDA’s growing responsibilities require a budget that grows.”
We also plan a round of virtual visits with both House and Senate offices on May 22-23.
Recap: All About the Alliance’s FY 25 Budget Ask. The Alliance for a Stronger FDA announced its FY 25 funding ask (here) for FDA, calling for a budget authority (BA) appropriation of $3.896 billion for salaries and expenses (S&E). This is $214 million more than the President’s FY 25 budget request and $377 million more than the FY 24 funding level.
The Alliance’s request for FY 25 is consistent with its request from a year ago and reflects that the FDA’s funding needs have not diminished in the intervening time. The ask will be the central document in the Alliance’s Hill visits this month and our advocacy throughout the FY 25 budget cycle.
FDA’s BA (non-user fee) revenue remained essentially the same between FY 23 and FY 24. Meanwhile, the agency was directed to absorb mandatory pay increases and implement new initiatives without corresponding funding. Combined, those realities put enormous strain on the FDA. The Alliance’s FY 25 “ask” covers further pay raise increases, while providing a broader view of the growing program imperatives facing the agency.
Summary and transcripts from FDA’s ORA Director Michael Rogers Available Soon; Video Available Now. On May 1, the Alliance hosted Michael Rogers, Head of the Office of Regulatory Affairs (ORA) and Associate Commissioner for Regulatory Affairs. Discussions surrounded inspections, compliance, enforcement, field force strategic planning, field laboratory and import operations at FDA. Find the recording here. The summary and transcript will be posted on our website next week.
All summaries and transcripts from the Alliance Webinar Series and our other webinars can be found on our website here.
Register for the Alliance’s Annual Budget Series. There are two more budget webinars scheduled. The links to register are below: