Agriculture/FDA Appropriations Likely to be Overtaken by a Continuing Resolution
This week’s Analysis and Commentary contains Dr. Califf’s comments on the impact of Artificial Intelligence (AI) on FDA regulation and staffing.
Agriculture/FDA Appropriations Likely to be Overtaken by a Continuing Resolution. Amid speculation of a potential government shutdown at the end of September, House Appropriations leaders continue working to overcome numerous hurdles to pass appropriations bills and reach an agreement on a Continuing Resolution (CR). While we hope that the Ag/FDA bill will be considered on the House floor next month, a CR appears to be inevitable regardless.
No official announcement has been made regarding full Senate action on the Ag/FDA bill in September. The Senate measure, S. 2131, was advanced by the Appropriations Committee on June 22nd.
Can Funding Disagreements Be Resolved? In a recent Analysis, the Alliance pointed to the many barriers to completion of funding bills, but concluded: “Eventually, funding disputes will be resolved, although it may take a government shutdown and might not be resolved in 2023.”
The Alliance Welcomed FDA Commissioner Califf on Tuesday. The Commissioner’s February 2023 webinar (here) was one of our most informative, providing an opportunity for multiple topics and multiple stakeholder interests to be discussed. Tuesday’swebinar was no different.
See Dr. Califf’s webinar transcript here and the summary here. You can also find all the transcripts & summaries of our past Alliance webinars on our website here.
See media coverage of our Alliance webinar with Dr. Califf here, here, here, here, here, here, and here.
FDA Names James Jones as the first Deputy Commissioner for Human Foods. FDA on August 23 named James “Jim” Jones to serve as the first Deputy Commissioner for Human Foods. He will lead the proposed unified Human Foods Program (HFP), including food safety, chemical safety, and innovative food products, including those from new agricultural technologies, as well as nutrition to help reduce diet-related diseases and improve health equity. Jones is scheduled to begin at the FDA on Sept. 24.
According to the FDA announcement, for more than 30 years, Jones has held various positions in the U.S. Environmental Protection Agency (EPA), stakeholder community, and private industry where he has managed teams and provided strategic planning and thought leadership around issues related to chemical safety and sustainability in the environment. His work has focused on lessening the impact that chemicals and pollution have on the U.S. food supply.
Along with the announcement of the Jones appointment, the FDA released a short presentation on how food programs and Office of Regulatory Affairs inspections will be reorganized (Twitter announcement here).
Upcoming Webinars:
FDA Chief Ombudsman Ms. Laurie Lenkel. August 30 from 2 to 3 p.m. Please register here!
The FDA Office of the Ombudsman is the agency's focal point for dispute resolution of complaints and disagreements between companies or individuals and FDA offices. They serve as consultants, and mediators, and oversee formal dispute-resolution mechanisms. Their goal is to assure fair and even-handed application of FDA policy and procedures.
Digital Health Center of Excellence, Acting Assistant Director of Digital Health Policy MiRa Jacobs, PhD. September 19 from 11 to noon. Please register here!
Artificial intelligence and machine learning (AI/ML) are profoundly impacting health care, food safety, and medical product development and manufacturing. More is coming. FDA’s Digital Health Center of Excellence is at the center of conversations to ensure innovations in this space to assist FDA and benefit the American public.
We have asked Dr. Jacobs to discuss the integration of AI/ML into FDA’s regulatory framework and also the challenge of recruitment and staff training in this area.
You can also find all the transcripts & summaries of our past Alliance webinars on our website here.
FY25 Budget Process Starting Now. Each year around this time, federal agencies prepare their budget requests to submit to the White House Office of Management and Budget. A memo sent on August 17 to agency leaders outlines the Administration’s R&D priorities and provides a glimpse into what the President may submit to Congress next year.
Did You Know: The Alliance Is On Twitter and Linkedin. The Alliance’s Twitter and LinkedIn provide updates, commentary, and everything you need to know regarding FDA resources and programs. Please give us a follow!