FY23 CR; No Change to User Fees; FDA Human Food Programs Review Panel Members
Top-Line
FY 23 Continuing Resolution Likely on House Floor the Week of September 12.
User Fee Legislation: Status Unchanged.
Panel Members Announced for FDA Human Food Programs Review.
September Events in the Alliance’s Webinar Series September 16 at 11:00 a.m. “Celebrating 10 years of Patient-Focused Drug Development”; September 27 at 11:30 a.m. “FDA and One Health.”
New Report: FDA’s Work to Combat the COVID-19 Pandemic.
This week’s Analysis and Commentary (below) discusses the current situation with the user fee reauthorization legislation and considers the question “what next?”
FY 23 Continuing Resolution Likely on House Floor the Week of September 12. With the new fiscal year starting on October 1 and no final action on FY 23 appropriations bills, Congress will move forward quickly in September to pass a Continuing Resolution (CR). According to Roll Call (here), during the week of September 12, he House intends to take up a CR running from October 1 through December 16 .
A critical and unresolved issue is what else might go onto the CR. Often, the CR covers only an extension of funding and some provisions (called anomalies) that prevent bad outcomes.
Republicans are expected to want a clean CR (i.e., nothing extraneous) in case they have more leverage post-election or next year. However, there is speculation that the CR might include disaster aid, more funds to support Ukraine, or a COVID supplemental. The treatment of existing policy riders may also become an area of significant disagreement.
Two recent Analysis and Commentary columns have discussed the timing, duration, and consequences of a CR in an election year. (August 12) (August 19). Among the questions answered: What happens to FDA funding under a CR; and, Why is a full-year CR unlikely?
User Fee Legislation: Status Unchanged. The House-passed and the Senate HELP Committee-passed bills both include non-user fee provisions. There is a prevalent view within Congress that House-Senate conferees can work quickly to resolve the differences. However, there is a dissenting view that the best option is to pass clean user-fee reauthorizations immediately and to address the non-user fee provisions separately and later.
This week’s Analysis and Commentary (below) is devoted to explaining the situation and considering the question “what’s next?”
Panel Members Announced for FDA Human Food Programs Review. Commissioner Califf requested the Reagan-Udall Foundation (RUF) to undertake an operational evaluation of FDA’s human foods programs.
On September 1, the Reagan-Udall Foundation (RUF) announced membership of the Independent Expert Panel that will conduct the review, naming former Commissioner Jane Henney as chair and adding:
Francisco Diez-Gonzalez, PhD, a food safety microbiologist and Director of the Center for Food Safety and a Professor at the University of Georgia;
James Jones, President of J. Jones Environmental, following a 30-year career at the U.S. Environmental Protection Agency;
Barbara Kowalcyk, PhD, directs the Center for Foodborne Illness Research and Prevention at The Ohio State University and chairs the FDA Science Board;
Shiriki Kumanyika, PhD, MS, MPH, Research Professor at Drexel University and chair of the National Academies Food and Nutrition Board;
John Taylor, JD, President and Principal at Greenleaf Health and held senior positions in his more than 20 years at FDA.
As stated by RUF: the Independent Expert Panel will focus on structure/leadership, authority, resources, and culture as it develops recommendations to equip FDA to better fulfill its regulatory responsibilities, strengthen its relationships with state and local governments, and secure the nation’s food supply for the future. (The review excludes cosmetic and dietary supplement responsibilities.)
Just Announced: September Events in the Alliance’s Webinar Series.
NEW: September 16 at 11:00 a.m. “Celebrating 10 years of Patient-Focused Drug Development.” Our guest will be Dr. Theresa Mullins, CDER Associate Director for Strategic Initiatives and one of the pioneers of PFDD. The webinar will be moderated by Mary Dwight of the Cystic Fibrosis Foundation and Ron Bartek of the Friedreich's Ataxia Research Foundation. REGISTER HERE.
Patient-focused drug development (PFDD) is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation. As experts in what it is like to live with their condition, patients are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation.
September 27 at 11:30 a.m. “FDA and One Health.” September 27, at 11:30 a.m. Our guests will include representatives from the Office of the Chief Scientist and the Center for Veterinary Medicine. REGISTER HERE.
“One Health” is an approach to solving health problems by recognizing the interconnection of people, animals, plants, and the environment. FDA is one of many federal agencies that support this approach and encourages its use. The webinar will explain the concept in more detail and feature presentations on how FDA’s work utilizes One Health. Subsequent program announcements will include more on the speakers and agenda
Newly Released Report: FDA’s Work to Combat the COVID-19 Pandemic. The report is here and describes FDA’s efforts on many fronts to lessen the impact of the pandemic.
“The FDA is responsible for monitoring the continued performance, safety, availability, and effectiveness of the COVID-19-related products on the market now, as well as in the years to come…The FDA continues to build on the foundation of scientific rigor, thoughtfulness, and adaptability in rising to this challenge.”