Califf and Woodcock Discuss Food Programs | Alliance Prepares for Budget Release
Topline
· Quick Turnaround for House Appropriation Requests.
· Commissioner Califf Announces Details on CFSAN and ORA Reorganization.
· Alliance Congratulates Tracey Forfa on Appointment as CVM Center Director.
· Alliance Webinar with Dr. Janet Woodcock Regarding FDA’s Proposed Human Foods Program
· Hillebrenner Discusses Diagnostics (transcript).
· Alliance FY 24 FDA Budget Webinar Series: Save the Dates.
This week’s Analysis and Commentary looks ahead to release of the President’s FY24 Budget Request with helpful reminders to keep in mind as the news rolls out on March 9. This is part 2 (Part 1from last week can be found here.)
Quick Turnaround for House Appropriation Requests. The President's Budget Request will be sent to Congress on March 9. The Alliance will release its review of the President's Budget Request as quickly as possible thereafter.
The House Appropriations Committee’s Subcommittee on Agriculture and FDA has now set its deadline for input from Members as March 24 at 6:00 pm.
Each year, Members of Congress ask their constituents and interested parties to recommend program funding for the coming fiscal year. In turn, Members formulate lists of their priorities, which they share with subcommittee leadership. Requests can be highly localized (monies to rebuild a bridge) or broadly programmatic (increases for FDA, for example).
Several members have already established personal office deadlines of March 17 or sooner. We are compiling a list of individual deadlines. Alliance members are urged to contact their representatives to encourage them to voice support for the FDA. Committee clerks constantly emphasize the importance of subcommittee chairs to hear directly from Members of Congress. Our goal is to reach out, particularly to members of the Appropriations Committee and the Health Subcommittee of the House Energy and Commerce.
The Senate Appropriations Subcommittee has not announced its deadline, but individual members are beginning to do so.
Contact Roger Szemraj for further assistance.
Commissioner Califf Announces Details on CFSAN and ORA Reorganization. On February 28, FDA provided an update on its January 31 announcement on food program reform. The new announcement covers the opening up of the search process for a new Deputy Commissioner for Human Foods and announces the proposed transfer of the cosmetics and color certification programs from CFSAN to the Office of the Chief Scientist.
The bulk of the announcement is devoted to details on how program initiatives, policy, budget and operational control with be shared between ORA and the Deputy Commissioner for Human Food. Specifically, “the FDA’s proposal will create a new model that better integrates ORA’s enterprise-wide expertise in field-based operations with product subject matter experts who sit in all the agency’s programs. The Deputy Commissioner for Human Foods and other program leads will be charged with setting strategic direction for food inspections and have authority over program resource allocation.”
In this latest announcement, FDA enumerated the steps and timeframe for completing the CFSAN/ORA reorganizations and related steps for program integration. By the Fall, FDA plans to have “a reorganization package that contains the newly designed structure, an established budget, and a detailed mapping and crosswalk of staff from the current to new organization.” That package will be thoroughly reviewed within the Executive Branch before being submitted to Congress. The submission triggers a 30-day period for Congress to raise any concerns.
Alliance Congratulates Tracey Forfa on Appointment as CVM Center Director. Ms. Forfa has been the Deputy Center Director since 2008 and has twice served as Acting Center Director. The Alliance congratulates her on her appointment as permanent Director of the Center for Veterinary Medicine.
Alliance Webinar with Dr. Janet Woodcock Regarding FDA’s Proposed Human Foods Program. On March 2, the Alliance for a Stronger FDA hosted a webinar with FDA’s Principal Deputy Commissioner Dr. Janet Woodcock, a key player in FDA's reexamination of food programs. At the start of this webinar, Dr. Woodcock offered a summary of the food program changes FDA announced on January 31 and supplemented with additional details this week.
Dr. Woodcock explained the planned restructuring of the foods program as bringing together multiple offices--including portions of ORA, CFSAN, and the animal food and feed component of CVM--into a new Human Foods Program that will be headed by a Deputy Commissioner. CVM will remain independent but will be matrixed into food matters. ORA will continue as an independent office but will be more strategic with respect to food, as well as part of the matrix management. This is a response to food programs that have been struggling against organizational obstacles, reflecting that food programs have been assembled by aggregation rather than intent.
In response to a question by Alliance Executive Director Steven Grossman about needed resources, she reiterated the overall underfunding of food programs and pointed to scientific staff and nutrition as particularly urgent. Some of the funding needs, she said, require sorting out the organization first.
A summary of some key points is here.
Hillebrenner Discusses Diagnostics. Last month FDA’s Elizabeth Hillebrenner participated in a webinar to familiarize the Alliance with her office’s work on diagnostics. A transcript of that conversation can be found here.
Alliance FY 24 FDA Budget Webinar Series: Save the Dates. The President’s FY 24 Budget Release is set for March 9. As in past years, we follow with a series of six budget webinars to explain FDA’s request. Registering at this point is a good way “to save the dates.”
3/23 Dr. Shuren, CDRH 11:00 Shuren event registration
3/29 Ms. McMeekin, ORA 2:30 McMeekin event registration
3/31 Dr. Mayne, CFSAN 11:00 Mayne event registration
4/04 Dr. Marks, CBER 3:30 Marks event registration
4/05 Dr. Cavazzoni, CDER 2:00 Cavazzoni event registration
4/10 Ms. Forfa, CVM 3:00 Forfa event registration