On Friday, January 19, 2024, I had the chance to join a webinar with the Alliance for a Stronger FDA and a distinguished panel of FDA personnel. This webinar intended to serve a few purposes - hold true to the word and goal for more transparency from the FDA and to learn more and discuss the proposed restructuring of the Food and Drug Administration.
Wow.
As I was sitting there, it dawned on me how major this moment actually is. The infant formula shortage put a large, public spotlight on a number issues within the FDA, including a lack of true authority or head of 'foods'. That is a pretty major finding! The infant formula shortage also laid the grounds for a need for an extensive review at responses, policies, and personnel.. (As you may remember, this review was spawned from the poor response time to the infant formula recall..)
During the webinar on Friday, Principal Deputy Commissioner, Janet Woodcock discussed many of the milestones and key points that have come about since 2022, as shown in the image above. Abbott and Similac initiated their infant formula recall officially on February 17, 2022. In reality, response and acknowledgment was fairly limited from a majority of government agencies and officials until May 2022. In July 2022, Deputy Commissioner, Dr. Robert Califf, requested an external evaluation of the foods program. In September 2022, the FDA released an internal evaluation regarding the infant formula response. I vividly remember how disappointing this review was. This review said very little with regards to some of the true issues, that those of us in the industry already knew about. Quite frankly, it felt very much like the FDA was gaslighting us all over again...
In December 2022, the Reagan U-dall foundation released their evaluation report of the human foods program. This report was a game changer.
Many of the issues and concerns were multiplied times 1000. And many were confirmed. There was no true head of "Foods" in the Food and Drug Administration. There were also tons of areas of evidence of poor communication and lack of reporting policies and many many other concerns. With this being public knowledge, the FDA was now required to be responsible. Some accountability would finally be had!
By January 2023, the FDA had announced they had a new vision for a unified human foods program, although what that vision actually looked like would not be revealed for many more months. During this time, the Deputy Commissioner of Food Policy and Response, Frank Yiannas, had announced that he would be leaving his position in February 2023. In March 2023, Mr. Yiannas, as well as Dr. Peter Lurie provided testimony to the oversight committee hearing regarding the infant formula shortage. This was followed with testimony from Director of the Center for Food Safety and Applied Nutrition, Dr. Susan Mayne, in May 2023.
Meanwhile, the restructuring planning had begun. And what started primarily as a restructure of the foods program, seemed to quickly expand to improve functions throughout most of the FDA. By the summer of 2023, it was known that the search was on for the first Deputy Commissioner of Human Foods. In September 2023, Jim Jones filled this position.
In November 2023, I was also able to join a call with many in the industry- welcoming Mr. Jones to his new position, and getting a chance to learn more about him.
A few things stuck out to me immediately.
He had been involved in the Reagan U-dall foundation review. This means that Mr. Jones was walking into his position, Already understanding exactly what needed fixed. And he felt he would be able to make the changes needed.
He has a history of work with the EPA and chemical control. Knowing that this is also a topic in the food and nutrition world, this experience and expertise will likely be very useful.
He and many others are already working to change the culture and landscape of the FDA.
In the midst of this meeting in November, the cinnamon applesauce recall had come to light, and Mr. Jones was able to show that he truly means change. He expressed some improvements already implemented such as quicker response times to complaints, clearer understanding of who to report these complaints to, and who is even in charge!
In December 2023, the FDA officially submitted the re-organization package/plan to HHS. It is currently undergoing the formal external review process required for all federal re-organization. The goal is for implementation to occur within 2024. And during the webinar on Friday, it was made clear that while formal implementation may not occur until later this year, many informal changes and improvements have already begun. These improvements include more direct communications, more collaboration, and beginning to work in new capacities as needed.
A few key changes to notice:
Every center previously reported directly to the Office of the Commissioner, including some of the smaller offices. There also seems to be a fair amount of overlap in the structure. This has been cleaned up to limit repetitiveness. Each Center will also have its own Deputy Commissioner to report to within their field. These individuals will then report directly to the Deputy Commissioner of the FDA.
For the human food program specifically, Mr. Jim Jones, the Deputy Commissioner of Human Foods will be in charge of all human foods. He will be the one to report directly to Dr. Califf, the commissioner of the FDA.
A good majority of staff/departments will be impacted by this reorganization, not just the foods program.
Major emphasis has already been placed on collaboration and improved communications across the FDA as a whole. There was also a great degree of focus on improving the culture at FDA, which is currently undergoing an overhaul as well!
The structure currently set up for 'Inspections and Investigations' will be getting quite an upgrade as well!
Cosmetics and colorings will be moving under the "Office of the Chief Scientist" with hopes and plans for additional insight and collaboration and works with Food Additives and Colorings!
Webpages and such will be updating over this year as well!
Additional Resources:
Distinguished FDA Panel Featured:
Deputy Commissioner Janet Woodcock,
Chief Scientist Namandje Bumpus,
Deputy Commissioner for Human Food Jim Jones,
Associate Commissioner for Regulatory Affairs Michael Rogers,
Acting CFSAN Director Donald Prater, and
Deputy Commissioner for Operations/COO Jim Sigg.
John Taylor (former Acting Deputy Commissioner for Global Regulatory Operations and Policy) and Alliance Board member Sarah Sorscher (Center for Science in the Public Interest) will be the co-moderators.
Official FDA Webpage for Proposal for a Unified Human Foods Program and New Model for the Office of Regulatory Affairs: https://www.fda.gov/about-fda/fda-organization/fdas-proposal-unified-human-foods-program-and-new-model-office-regulatory-affairs
Politico Article, 'FDA Focuses on Reorg' by Lauren Gardner and David Lim: https://www.politico.com/newsletters/prescription-pulse/2024/01/17/fda-focuses-on-reorg-plan-00135884
Alliance For A Stronger FDA website: https://www.strengthenfda.org/
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