Food Safety Reform Still A Pressing Issue for FDA and Stakeholders.
TOP LINE
Fireside Chat with FDA Commissioner Robert Califf.
Webinar on FDA Diagnostics Programs with Elizabeth Hillebrenner of CDRH.
Food Safety Reform Still Pressing Issue for FDA and Stakeholders.
ORA Re-organization Has A History; Not Just Aimed at Food Safety.
President’s State of the Union—No Direct Impact on FDA.
Alliance FY 24 FDA Budget Webinar Series: Save the Dates.
This week’s Analysis and Commentary responds to key questions: Why do food and medical product stakeholders need each other? Why were the first actions on food safety reform met with mixed reviews? How will this year’s budget be resolved?
TODAY: Fireside Chat with FDA Commissioner Dr. Robert Califf from 2:30 to 3:30 pm. Register here. Last chance to sign up and hear Commissioner Califf talk about his first year and his vision for the future of FDA.
NEXT WEEK: 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..
Food Safety Reform Still A Pressing Issue for FDA and Stakeholders. The Alliance’s position is that food safety reform and additional resources go together. Either will fail without the other.
We have also acknowledged what many of our Alliance members’ have told us: until there is a clear demonstration of change, the broader food stakeholder community will not be ready to advocate for additional resources for FDA food programs.
Part of this week’s Analysis and Commentary (below) explores “why there were mixed reactions to Commissioner Califf’s proposed creation of a Deputy Commissioner for Human Foods.” As explained below, the major concerns are about the ambiguous relationship between the new Deputy Commissioner and the food component of the Office of Regulatory Affairs.
A group of consumers, state agencies, and industry wrote a letter to Commissioner Califf earlier this week 1/ asking specific questions about the Deputy Commissioner/ORA relationship and 2/ expressing their concern that the line management authority of the Deputy Commissioner would be incomplete if it did not include the food component of ORA. (Food Safety News reprinted that letter here). Our understanding is that they will be meeting with Dr. Califf soon to discuss their concerns.
In the interim, further insight could become available during the Alliance’s Fireside Chat with Commissioner Califf (today, Friday February 10 at 2:30; registration link above). One of the questions he will be asked is: “Can you describe the plans for reorganizing the Office of Regulatory Affairs so that it is more responsive to food safety needs?”
ORA Re-organization Has A History; Not Just Aimed at Food Safety. On February 7, FDA Today (a free publication from Politico’s AgencyIQ) published an analysis of ongoing re-organization of FDA’s Office of Regulatory Affairs (ORA).
FDA Today: “Some early hints on realignment at ORA came when McMeekin spoke in July 2021 at an Alliance for a Stronger FDA webinar. Noting first that ORA employs about 5,000 FDA staffers in over 200 offices across 49 states, she added that her ORA leadership role “really allows me to see the need for an enterprise or FDA-wide approach.”
At that webinar Ms. McMeekin described the new FDA Inspectional Affairs Council (FIAC), which draws on leadership across the agency and within ORA. (Alliance transcript of McMeekin webinar).
FDA Today: “In August 2022, FDA Principal Deputy Commissioner Janet Woodcock spoke at another Alliance event centered on data modernization efforts across the agency. The discussion at that meeting provided some deep insight into how outmoded technology, data silos, and a fragmented workflow have hampered the agency’s efforts to modernize inspectional work.”
At the webinar, Dr. Woodcock described the need for a standard set of data elements for inspections to be carried on a “single workflow pattern management platform” (Alliance transcript of Woodcock webinar).
To be noted: this is context for the current discussions between Drs. Califf and Woodcock and the food safety community. It doesn’t change what’s being requested by the food community and the FDA’s yet-to-be announced details. However, it does underscore 1/some of the complexity and 2/ the need for resources once the details have been worked out satisfactorily.
And yes, we are pleased that FDA Today used two of the Alliance’s webinars to explain the evolution of FDA thinking about re-imaging ORA’s functions and process.
President’s State of the Union—No Direct Impact on FDA. The President’s SOTU covered a number of health care topics: Medicare solvency, opioids, cancer moonshot, drug pricing, and COVID-19. While these may have secondary impacts on FDA, all of them have a primary assignment at agencies other than FDA. For FDA, the next pivotal budget development will be release of the voluminous agency Congressional Justification (CJ) as part of the President’s FY 24 budget request. That document is slated for release on March 9.
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 Cavazzonni event registration
4/10 Ms. Forfa, CVM 3:00 Forfa event registration