Time is on my side, yes it is . . .”
Written by Jerry Ragovoy performed by The Rolling Stones
Nothing could be further from the truth than that song lyric regarding the work ahead for the first-ever deputy commissioner for human food at the Food and Drug Administration.
During a round table discussion on Thursday with a select group of journalists, Deputy Commissioner Jim Jones repeatedly said it would take time for him to get things in order at the sub-agency of the FDA. He comes to the FDA in the midst of a tumultuous time. He was formerly an administrator at the EPA. His selection as FDA’s first deputy commissioner for human foods was preceded by the infant formula crisis of 2022 and the failure of internal communications that helped bring the crisis and other problems to light during congressional hearings.
Members of the House of Representatives, consumer advocacy groups, and individual consumers have expressed concerns that the agency was in a mess so severe it was hampering all aspects of its work, especially food safety. They called for more transparency and faster action when foodborne problems arise. They expressed a general lack of confidence in the food side of the massive Food and Drug Administration. They admitted that part of the problem could be traced to the fact that the food side of the FDA gets a tiny slice of the agency’s funding pie, but also said that the food piece of the pie should be sliced up differently to better fund food safety efforts.
I asked Deputy Commissioner Jones what he can do to restore confidence in the workings of the food side of the FDA. He is a lifelong bureaucrat — coming to the FDA from the EPA — and some critics have said he will perpetuate the so-called white-guys-in-ties government operational style in his new post. But he didn’t skirt the question of restoring confidence with a word salad of bureaucratic speak that so many administrators fall back on. He put the responsibility squarely on his shoulders. He said spending time with stakeholders, members of Congress, producers, and consumers will be the key. In his first month on the job, he has already met with groups that have given him key data. And he has concrete plans to continue his travel around the country.
In his first month, Jones has met with congressional members on Capitol Hill. He has gone to California to meet with food producers. He has met with many state officials and has a travel schedule for next week and weeks after to meet with more people in those groups.
“The point is not to build goodwill but to make decisions at the end of the day,” Jones said.
In actuality, the “end of the day” could take months to reach, with some problems taking years to resolve, but he said he is also ready for the agency to act quickly if problems arise that need immediate attention. “We hope that doesn’t happen, but we know it will sooner or later,” he said.
Accompanying his round table remarks, the deputy commissioner released a statement about top priorities currently on his plate. Food safety is one of those priorities. In his written statement and opening remarks before the question and answer section of Thursday’s round table discussion, the deputy commissioner mentioned the restructuring of lines of communication in the Human Foods Program. Previously, numerous FDA administrators reported directly to FDA Commissioner Robert Califf in a starburst organizational chart. With Califf appointing Jones as deputy commissioner, all administrators and heads of offices in the Human Foods Program report to Jones. The Human Foods Program is being reorganized so there are transparent chains of command to enhance internal communication.
The deputy commissioner also said the regulatory framework should involve states but also not burden states or confuse consumers. “The more active (we) are, the less the states feel they need to act. It shouldn’t be a function of where you live.”
Other paraphrased questions fielded by Jones during the round table
Question: The Reagan Udall Report commissioned by FDA Commissioner Califf during the infant formula crisis praised staff but raised concerns about the regulatory process. What can you do about that?
Answer: We will go with voluntary processes first if they move the ball forward; if not, regulations will come into play.
Question: With the infant formula situation, where do we stand? If illnesses occurred again, how quickly would you know? How quickly would you act? How quickly would you tell the public?
Answer: We are closely monitoring the manufacturing situation, which means investigators can find problems more quickly. The goal is to get it done faster.
Question: If there were a report of cronobacter, how long would it take before you act?
Answer: We will act as soon as we know.
Question: Food manufacturers fear how whole genome sequencing could be used against them. What can you tell them?
Answer: It should help us find problems faster and allow us only to go where the problem is instead of shutting down an entire industry; it should make problem situations less disruptive and help us only go where we are needed.
Question: What can you do with status quo funding?
Answer: The activities I have discussed are not contingent on funding.
Question: The Reagan Udall report discussed the need for cultural changes in the program. What will you do in that area?
Answer: Culture comes from the top. The structure was problematic because the staff didn’t know how to proceed. But I won’t be making all of the decisions. People will understand what cultural decisions to make and when and how to make them.
Question: How are you incentivizing the infant formula industry?
Answer: We have been tracking it, and it has given us a better line of site.
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