Commissioner Califf Testifies in Senate; House/Senate Appropriations Leaders Have First Informal Chat About Total Spending for FY 23; Inspections, Budgeting, and the Pandemic
Top-Line:
Commissioner Califf Testifies Before Senate Ag/FDA Appropriations Subcommittee.
Alliance Has More Hill Visits Planned in May and June; Seeking Sign-Ups
House/Senate Appropriations Leaders Have First Informal Chat About Total Spending for FY 23.
More on FDA Inspections, Budgeting, and the Pandemic.
Hear FDA Leaders Discuss FY 23 Budget Priorities.
Peter Marks, MD | CBER | May 10, 1 p.m. | Register
Why Sign-Up to Listen to Dr. Marks?
This week’s Analysis and Commentary summarizes 1/ Dr. Califf’s testimony this week to the Senate Appropriation Committee’s Ag/FDA subcommittee; and 2/ CVM Center Director Dr. Solomon’s webinar on FY 23 budget priorities with the Alliance.
Commissioner Califf testifies before Senate Ag/FDA Appropriations Subcommittee. FDA Commissioner Robert Califf appeared on Thursday, April 28, 2022, before the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies in support of the FDA’s Fiscal Year (FY) 2023 budget request. The Commissioner's prepared statement can be found here. A video of the hearing can be found here.
A similar hearing had been scheduled for Wednesday before the House Ag/FDA appropriations subcommittee. It has been postponed, and not yet rescheduled.
This week’s Analysis and Commentary contains a summary of Dr. Califf’s remarks, as well as a link to a longer summary.
Alliance Has More Hill Visits Planned in May and June; Seeking Sign-Ups. The Alliance conducted nearly 50 Hill visits during March and April. We expect to do more in May and June. If you would like to be on our priority list to participate in these future Alliance Hill meetings, please contact Elisa Bayoumi.
House/Senate Appropriations Leaders Have First Informal Chat About Total Spending for FY 23. Reportedly, informal discussions about total FY 23 spending were to be held this week by Appropriations leaders. Senate Appropriations Chair and Ranking Member, Senators Leahy and Shelby were to be involved, along with House Appropriations Chair and Ranking Member, Representatives DeLauro and Granger.
The expectation was that the meeting would be very preliminary, just the first step toward the leaders agreeing on Section 302(a) total spending levels for FY 23. Most years, the Committees move to complete the individual spending bills, but the process stalls until there is a bipartisan and bicameral agreement on total spending. Reaching an agreement early would likely accelerate the appropriations process this year.
More on FDA Inspections, Budgeting, and the Pandemic. The Alliance’s April 6 webinar with Judy McMeekin, Associate Commissioner for Regulatory Affairs, was well-received, reflecting increasing interest in how FDA’s Office of Regulatory Affairs operates. The Pink Sheet’s Bowman Cox used the McMeekin presentation as a starting point to look more deeply into the pandemic’s effect on ORA and how pandemic savings from reduced travel were allocated to related programming. His story is here: US FDA Strengthens Inspection Capabilities With Pandemic Alternatives – And Travel Savings. Our thanks to Informa for permitting us to redistribute the article.
Hear FDA Leaders Discuss FY 23 Budget Priorities. Hear FDA leaders discuss their FY 23 budget priorities as part of this exclusive Alliance webinar series.
• Peter Marks, MD | CBER | May 10, 1 p.m. | Register
These online events are for Alliance members and media, although we welcome guests. If you are not an Alliance member and would like to participate, please contact Alliance Executive Director, Steven Grossman.
Also, we have audio and, in most cases, transcripts of the six Alliance webinars this year. They cover the FDA Office of Chief Scientist, How FDA is Funded, CDER, the Office of Regulatory Affairs, CFSAN and CVM. If you are interested, contact Elisa Bayoumi. Also, a summary of CVM Director Steven Solomon’s webinar is in this week’s Analysis and Commentary.
Why Sign-Up to Listen to Dr. Marks? The Center for Biologics Evaluation and Research (CBER) protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.
Even without its pivotal role in responding to COVID-19, CBER covers a vast array of cutting-edge medical product areas, including blood and blood products, cellular and gene therapy, tissue and tissue products, vaccines, and products involving xenotransplantation.
Dr. Marks will review CBER’s FY 23 budget request and opportunities for CBER to play a pivotal role in the future of gene therapy, vaccines, and orphan drugs. Making our blood supply ever-safer is also a continuing challenge for CBER.
