Commissioner Califf to Testify Before House Appropriations Committee; FDA Leaders Discussing FY 23 Budget Priorities; the House User Fee Bill
Top-Line:
Commissioner Califf to Testify Before House Appropriations Committee About FY 23 Funding Priorities and Infant Formula
Alliance Encourages FDA Stakeholders to Submit Testimony to the House Ag/FDA on FY 23 Funding
Alliance Plans More Hill Visits in May and June; Seeking Sign-Ups
FDA Leaders Discussing FY 23 Budget Priorities and Other Alliance Webinars.
For Those Interested in the House User Fee Bill.
Advanced Manufacturing Can Create Patient-Specific Products On Site.
This week’s Analysis and Commentary summarizes the remarks of Dr. Jeff Shuren, Director of the Center for Devices and Radiologic Health (CDRH). It also links to a longer summary and the transcript.
Commissioner Califf to Testify Before House Appropriations Committee About FY 23 Funding Priorities and Infant Formula. On May 19 at 10:00 AM, the Agriculture Appropriations Subcommittee will be holding a hearing with Commissioner Robert M. Califf on the FDA’s fiscal year 2023 budget request as well as oversight of infant formula.
Alliance Members Encouraged to Submit Testimony to House Ag/FDA Subcommittee in Support of the Alliance’s FY 23 “Ask.” The Alliance for a Stronger FDA supports the Administration’s BA request of $3.653 billion. This provides for an increase of $336 million in budget authority (BA) funding. Of that, $318 million would increase BA salary and expenses (S&E) and $18 million would increase BA buildings and facilities (B&F). We already submitted Senate testimony that advocates for this position (here).
There is a similar opportunity to submit testimony in the House, with a due date of May 31, 2022. Accordingly, the Alliance encourages all members to submit testimony to the House in support of the Alliance “ask” for FY 23 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. For more information on the key message points, check here and the two-page document that we have been using in Hill meetings, here. In addition, Alliance staff welcomes requests for assistance in preparing testimony in support of FDA funding.
Alliance Plans More Hill Visits in May and June; Seeking Sign-Ups. The Alliance conducted more than 50 Hill visits during March and April. We expect to do more later in May and in June. If you would like to be on our priority list to participate in these future Alliance Hill meetings, please contact Elisa Bayoumi.
FDA Leaders Discussing FY 23 Budget Priorities and Other Alliance Webinars. Over the last five weeks, six FDA leaders discussed their FY 23 budget priorities as part of an exclusive Alliance webinar series. This series includes remarks by CDER Director Patrizia Cavazzoni (April 4), Associate Commissioner for Regulatory Affairs Judy McMeekin (April 6), CFSAN Director Susan Mayne (April 12), CVM Director Steven Solomon (April 22), CDRH Director Jeff Shuren (April 29), and CBER Director Peter Marks (May 10). Dr. Marks’ webinar will be summarized in next week’s (May 20) Analysis and Commentary.
We have audio, summaries and, in most cases, transcripts of all six of the budget presentations. Additionally, we have materials from our January webinar with the FDA’s Acting Chief Scientist and our February webinar on How FDA is Funded. If you are interested in any of our eight completed webinars, please contact Elisa Bayoumi.
For Those Interested in the House User Fee Bill. Politico’s Agency IQ regulatory monitoring and analysis service has produced an exhaustive analysis of the House user fee bill. They have given us permission to circulate it to Friday Update readers. Analysis of the bill as introduced is here. An update that describes changes in the bill prior to mark-up and proposed changes from the mid-week mark-up is here.
Advanced Manufacturing Can Create Patient-Specific Products On Site. Space-permitting, Friday Update always likes to feature food safety and medical product innovations that illustrate why FDA needs to be well-funded and have staff who understand innovative technologies. This week brings a story (here) about how radiation therapy can be better targeted and less of a threat to surrounding tissue using a customized shield. The shield can be created in a health care setting using onsite 3-D printers.
