FDA Proposes to Reorganize Food Safety; More Details Coming
It is official: the FY 24 President’s Budget Request will be released on March 9. Accordingly, this week’s Analysis and Commentary discusses budget content and structure, how we review the 400-page Congressional Justification, and what information we provide to stakeholders and the media. Links are provided to the Alliance’s budget series webinars with FDA leaders.
NEXT WEEK: Fireside Chat with FDA Commissioner Dr. Robert Califf on Friday, February 10, 2:30 to 3:30 pm. Register here.
February 10 is just a week shy of Dr. Califf’s 1-year anniversary as Commissioner. He has agreed to do a fireside chat with the Alliance to discuss his first year and his vision for the future for FDA.
We also expect discussion of last year’s legislation, food safety, cell and gene therapy, cosmetics safety, and regulation of innovative products. As well, we will want to hear about his progress in recruitment and retention of scientific staff and plans for investment in technology that will strengthen the agency.
FDA Announces Plans to Re-organize Safety Programs; More Details Coming. On January 31, Commissioner Califf and Principal Deputy Commissioner Woodcock presented the first set of changes to food safety programs (here). More details are to be released in 30 days.
Under this plan, the functions of the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), as well as certain functions of the Office of Regulatory Affairs will be unified into a newly envisioned organization called the Human Foods Program, to be led by a new Deputy Commissioner for Human Foods.
The re-organization was a response to last year’s infant formula crisis and based on:
recommendations from the December 2022 Reagan-Udall Foundation review of FDA human foods programs; and
information received by the Commissioner at January 2023 listening sessions.
The Alliance testified before the Reagan-Udall Foundation (here) and had its own listening session with Drs. Califf and Woodcock (see What the Alliance Told the Commissioner About Food Safety).
The Alliance’s press release applauded the agency’s efforts and noted:
"The creation of a Deputy Commissioner for Human Foods is not just about the arrangement of boxes on an organizational chart. With five different units within FDA using food and nutrition funding, resources cannot be spent effectively and with appropriate intentionality, unless there is an empowered decision maker in charge.”
“The responsibilities placed on FDA and the growth of challenges in food safety have increased far faster than funding. Significant new monies are needed to assure that the food supply is safe and perceived to be so, and nutritional information is widely available and supported by science.”
Webinar on Diagnostics with Elizabeth Hillebrenner, CDRH Associate Director for Scientific and Regulatory Programs. Wednesday, February 15 from 2:00 to 3:00 pm. Register here.
This educational webinar is intended to highlight FDA’s role in the current regulatory landscape for diagnostics and underscore why regulation in the diagnostics space remains so complicated. Attempts to pass legislation clarifying FDA’s statutory authority with respect to diagnostics fell short in the last session of Congress and the FDA has said it may consider using its rulemaking authority in this area.
The webinar will also cover topics such as increased staffing and resource needs for the agency if it is required to oversee a larger number of diagnostics in the future. The webinar will be at 2 p.m. on February 15. Register here.
Transcript Available from January 13 Webinar with Deputy Commissioner Fristedt. On January 13, 2023, the Alliance for a Stronger FDA held an informative webinar with Andi Fristedt, FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs. She covered a wide range of issues including: the user fee actions taken by Congress last September; the additional authorities provided to FDA as part of the Consolidated Appropriations Act of 2023; priorities for the coming year; and anticipation of challenges facing the FY 2024 budget request.
Her remarks are summarized here. A transcript of the session is now available here.
Reminder to Alliance Members. On Monday, January 16, Alliance members received an online link to register approval/disapproval/abstention for a new slate of directors whose term will run through 2024. They will join others on the board whose terms run through 2023.
If you have not already responded, please follow this link for additional information and register your organization’s position here. We have a busy year ahead and your board members provide incredibly valuable insights and service