Agriculture/FDA Appropriations in Limbo as End of Fiscal Year Looms
This week’s Analysis and Commentary explores FDA funding in both absolute and relative terms.
Agriculture/FDA Appropriations in Limbo as End of Fiscal Year Looms. 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. We hope that, as a result, the Ag/FDA bill will be considered on the House floor next month.
Prior to adjournment for August recess, the House Rules Committee began consideration of a rule to advance the measure, HR 4368, but were unable to conclude negotiations. Various reports suggest disagreements among Republican Members regarding further spending cuts, SNAP work requirements, and proposed restrictions on prescribing mifepristone. A total of 189 amendments (of which 32 are related to the FDA) were filed and can be found here. Which of these may be made in order for floor consideration is yet to be determined.
A SAP (statement of administration policy) and veto threat issued by OMB says “funding reductions contained in the bill would leave the FDA underprepared to address ongoing and urgent public health challenges in FY 2024.” See the Executive Office OMB statement here.
On the Senate side of the Capitol, there is speculation that an Ag/FDA bill could potentially see floor action in September though no official scheduling announcement has been made. The Senate measure, S. 2131, was advanced by the Appropriations Committee on June 22nd.
With crowded calendars and uncertainty in both chambers, a Continuing Resolution - IF one can be achieved to avoid a government shutdown - seems to grow more likely.
The Alliance Welcomed FDA Chief Scientist Dr. Namandjé Bumpus This Past Wednesday. The Office of the Chief Scientist (OCS) is a hub for scientific programs that support the Centers and the overall FDA mission, including regulatory science, the National Center for Toxicological Research, technology transfer, scientific professional development, and advisory committee management. The Office of Cosmetics and Colors will be moved into OCS in the near future.
See Dr. Bumpus’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.
Upcoming Webinars:
FDA Commissioner Dr. Robert Califf. August 16 from 1 to 2 p.m. Please register here!
The Commissioner’s February 2023 webinar with the Alliance (here) was one of our most informative, providing an opportunity for multiple topics and multiple stakeholder interests to be discussed. Dr. Califf has agreed to do another fireside chat with us later this month. If you are interested in FDA priorities, this is a must-see event.
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 MiRa Jacobs, PhD. September 19 from 11 to noon. Mark your calendars/registration link coming soon.
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 assist FDA and benefit the American public.
We have asked Dr. Jacobs to discuss integration of AI/ML into FDA’s regulatory framework and also the challenge of recruitment and staff training in this area.
Did You Know: You Can Find Our Weekly Analysis and Commentary On the Alliance’s Website. For more than a decade, the Alliance’s Friday Update has included an “Analysis and Commentary” covering FDA programs and funding, the budget and appropriations process, and the costs and needs associated with FDA’s expanding mission and growing responsibilities. All the columns are on the Alliance website and can be searched by key words.
Friday Update Publication Schedule During August Recess. Friday Update will not publish on August 11 and August 25. We will bring you advocacy information and “Analysis and Commentary” on August 18 (mid-recess) and then on September 1 (previewing Congress’ return to DC). If there is important news to report on the off-weeks, we will provide special editions.
Regardless of the publication schedule, the Alliance staff will be available to our members and media throughout the Congressional recess.