How FDA Is Funded; User Fee Reauthorization Legislation Released in the House; White House Conference on Hunger, Nutrition, and Health Announced for September
Top-Line:
How FDA Is Funded; User Fee Reauthorization Legislation Released in the House
White House Conference on Hunger, Nutrition, and Health Announced for September
Alliance Has More Hill Visits Planned in May and June; Seeking Sign-Ups
House/Senate Appropriations Leaders Have Informal Chat About Total Spending for FY 23.
Hear FDA Leaders Discuss FY 23 Budget Priorities. Last of the series.
Peter Marks, MD | CBER | May 10, 1 p.m. | Register
Why Sign-Up to Listen to Dr. Marks?
This week’s Analysis and Commentary encourages Alliance members to submit testimony on FY 23 FDA funding to the House Appropriations Subcommittee on Agriculture, Rural Development, and the Food and Drug Administration. The commentary provides directions and talking points. Submissions must be to the Subcommittee by May 31.
How FDA Is Funded/User Fee Reauthorization Legislation Released in the House. Earlier this year, the Alliance circulated materials to the Hill and our members about How FDA Is Funded. A link is here.
The Alliance’s focus is on Budget Authority (BA) appropriations, which come from the U.S. Treasury and represents taxpayer funding. The $3.3 billion in BA funding that FDA received in FY 22 pays for nearly 60% of FDA’s activities (excluding tobacco user fees). Establishing BA funding levels is an annual process.
The bulk of medical products user fees are on a 5-year cycle that requires them to be renewed by September 30 of this year and, as a practical matter, should be renewed by August 1. So, the introduction in the House this week of a user fee reauthorization bill is important news for FDA. The details are here and also widely discussed in trade publications.
White House Conference on Hunger, Nutrition, and Health Announced for September. The first such White House Conference was 55 years ago and was never repeated, making this a noteworthy event. The Domestic Policy Council and the Secretaries of Agriculture and Health and Human Services will be involved. Some initial details are here.
On the White House call earlier this week, there were references to multiagency involvement but no explicit reference to FDA participation. We will track this closely in forthcoming Friday Updates and will publish any details we receive about what role, if any, FDA will play.
Alliance Has More Hill Visits Planned in May and June; Seeking Sign-Ups. The Alliance conducted over 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 Informal Chat About Total Spending for FY 23. Informal discussions about total FY 23 spending occurred last week. The participants were Senate Appropriations Chair and Ranking Member, Senators Leahy and Shelby, along with House Appropriations Chair and Ranking Member, Representatives DeLauro and Granger.
After the meeting, Representative DeLauro and Senator Leahy expressed some optimism about getting a framework and then a deal in place. Senator Shelby’s comments were positive, while warning that election year politics might make an agreement difficult to reach.
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. This is the last of our budget priorities series, which has included the 5 Center Directors and the Associate Commissioner for Regulatory Affairs.
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 seven 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. A summary, transcript, and links to the presentation by CDRH Director Jeffrey Shuren should be available next week. If you are interested, contact Elisa Bayoumi.
Why Sign-Up to Listen to Dr. Marks? The Center for Biologics Evaluation and Research (CBER) protects and advances 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.
