FY24 Appropriation Deadline Approaching
Last week’s Analysis and Commentary summarized the Administration’s FY 24 Budget Request for FDA and asked Alliance members to provide feedback on their organization’s priorities. This week’s Analysis and Commentary explains, in Q&A format, how the Alliance’s “ask” is put together and why Alliance member feedback is so important. Please provide feedback to Steven Grossman.
First Set of Alliance Hill Days Announced. Please Sign Up To Participate. 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. More dates—both virtual and in-person—will be announced soon.
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 is certain to be a challenging appropriations cycle and your voice is important.
Testimony Deadlines: Senate on March 31; House on April 10. There are opportunities to submit testimony to the Ag/FDA Appropriations Subcommittees. 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. 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).
We welcome requests for assistance in preparing testimony in support of FDA funding. Contact Roger Szemraj if you need our help.
Webinar Series on FY 24 Budget: CDRH Director Jeff Shuren. CFSAN’s Director on March 31. On November 23, the Alliance held the first of six webinars on FDA’s FY 24 Budget Request. Our guest was Dr. Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health. He focused his remarks on: transition from COVID to the new normal; implementation of the new MDUFA 5 agreement; working with the Hill (appropriations, renewal of the Pandemic and All Hazards Preparedness Act, and diagnostics); and his Center’s efforts to promote health equity. He also answered a number of questions from the moderators and the audience.
A summary of his remarks is here. A transcript should be available by the middle of next week or sooner. We will be posting it to the Alliance website and linking to it in next week’s Friday Update. Also, let Phil Karsting know if you need a recording or the transcript as soon as it is available.
Alliance Meets with FDA on Cosmetics Reform. On March 22, the Alliance and ten of its members met with FDA Chief Scientist Dr. Namandjé N. Bumpus and Cosmetics Office Director Dr. Linda Katz. The topic was the recently-enacted Modernization of Cosmetics Regulation Act (“MoCRA”). Prior to MoCRA, the last change in cosmetic safety regulation was 1938.
The Alliance was primarily concerned about the program’s resource needs. There is no money in the FY 23 (current year) appropriation to pay for implementation, so initial efforts are being staffed by detailees and temporary reassignments. The President has $5 million in his FY 24 request. Undoubtedly, more money will be needed.
If you are an Alliance member interested in cosmetics reform (but not at the meeting), please let Steven Grossman know.
2023 Alliance Webinar Series: Center Directors Discuss Their FY 24 Budget Requests: CFSAN’s Director on March 31. We have further upgraded our webinar series in 2023, with more programs and a broader range of FDA speakers.
Next week, on March 31 at 1 p.m., we will hear from Dr. Susan Mayne, Director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN). This is the second webinar in our FY 24 budget series, which will feature all of the Center Directors and the head of the Office of Regulatory Affairs.
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
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