Alliance Members Urged to Participate in Senate and Virtual Hill Days
This week’s Analysis and Commentary is entitled “Three Things We Heard in House-side Hill Meetings.”
Alliance Members Urged to Participate in Senate and Virtual Hill Days. Alliance teams will have in-person meetings with Senate offices on May 15 and 16. We are also in the process of scheduling additional virtual meetings with House and Senate offices on May 22 and May 23.
We strongly encourage Alliance members to join us for these visits. Please let Ben Dash know of your availability for May 15, 16, 22, or 23. Non-members interested in participating should contact Steven Grossman.
Register for the final webinar in the Alliance’s Annual Budget Series: CDRH Director Dr. Jeff Shuren. Director Dr. Shuren will be wrapping up the Budget Series on Tuesday, May 14 at 2 pm. Register here.
Hill Days Underway. Teams of Alliance members met with staff of nearly 30 members of the House Appropriations Committee and the Health Subcommittee of the House Energy and Commerce Committee this week. The Alliance’s recommendations for FDA’s FY 25 budget were presented, focusing on the need for additional resources to adequately fund FDA’s growing responsibilities. Teams included representatives who spoke to FDA’s food, medical product, and veterinary medicine activities.
The diversity of the Alliance team and the unified message about FDA’s needs was expressly recognized in several meetings. More about the House Hill meetings is in this week’s Analysis and Commentary.
Alliance Submits Statements to House and Senate Appropriation Subcommittees. The Alliance for a Stronger FDA submitted statements to the House and Senate Agriculture/FDA Appropriation Subcommittees detailing the Alliance’s recommendations for FY 25 FDA funding levels. The House statement can be found here, and the Senate statement here. The FY 25 funding “ask” calls 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.
House 302(b) Allocations Being Developed with Markups Forthcoming. House Appropriations Committee Chairman Tom Cole (R-OK) this week said he hopes to provide the twelve subcommittees “round numbers to work with” by the end of next week. He expects the amounts will be adjusted over time,including following the Congressional Budget Office’s release of federal receipts data on May 22. His goal is to begin subcommittee markups in late May or early June, and have all twelve bills approved by the full Committee before the August recess.
FDA Appeared Before Senate Appropriations on Wednesday. Commissioner Califf appeared before the Senate Agriculture/FDA Appropriations Subcommittee on Wednesday, May 8, at 10:00 regarding FDA’s FY 25 budget request.
Subcommittee Chairman Martin Heinrich (D-NM) in his opening statement (here) said the $168 million increase over FY 24 enacted is “modest”. He also said that they had to make difficult decisions under grim spending caps last year, and that he is afraid this year will not be much better. Ranking Member John Hoeven (R-ND) said that FDA has to get it right, and get it right every time - that is what Americans expect. Topics raised during the hearing included substantial discussion of avian influenza and its possible transfer to humans; continuing concerns about infant formula; the role of states in food safety enforcement; medical gasses; enriched enrollment of opiates; and mifepristone.
A video of the hearing and a link to Dr. Califf’s prepared statement can be found here.
FDA Center Directors to Appear Before House Energy and Commerce Subcommittee on Health May 22. The Subcommittee on Health has scheduled a hearing titled "Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices” on May 22 at 10:30. Those scheduled to appear include: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research (CDER); Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research (CBER); and Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH).
The Alliance hosted CDER Director Dr, Patrizia Cavazzoni on May 6. On May 6, the Alliance hosted Dr. Patrizia Cavazzoni, Director of FDA's Center for Drug Evaluation and Research (CDER). We had fruitful conversations about drug development and drug safety at FDA. Find the summary here and the transcript here.
Summary, transcript, and presentation slides from FDA’s ORA Director Michael Rogers are now available. 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 summary here, the transcript here, and the presentation slides here.
All summaries and transcripts from the Alliance Webinar Series and our other webinars can be found on our website here.