Special Edition; Transcript of Woodcock Discussing Food Programs at Alliance Webinar
On March 3, 2023, the Alliance for a Stronger FDA hosted a webinar with Dr. Janet Woodcock to discuss emerging changes in food programs at the FDA. Below is a lightly edited transcript of that conversation.
Tom Kraus: We’re just going to wait a few more minutes to get started. [No dictation] [00:00:26 - 00:01:10] Okay, good afternoon. Thank you so much for joining us today. I’m Tom Kraus from the American Society of Health System Pharmacists. I am also the Vice President of the Alliance for a Stronger FDA. Today, I am joined by the Alliance’s Executive Director, Steven Grossman, and several Alliance members: Sara Sorscher from the Center for Science in the Public Interest. Donna Garren from the American Frozen Food Institute and Thomas Gramillion from the Consumer Federation of America.
They will be acting as co-moderators for our discussion with Dr. Woodcock. But first, I just want to say a few words about the Alliance. As a former FDA’er, I am very proud to continue supporting the agency through the Alliance for a Stronger FDA. We are delighted to have a large number of Alliance members, media participants and guests for today’s webinar. The Alliance is a multi-stakeholder coalition of FDA supporters. We advocate for increased appropriated resources for FDA and have been an important source of funding, an important force for doubling FDA’s budget authority from $1.6 billion to more than $3.5 billion.
We also spend a lot of time educating policy makers and the American people and media about FDA’s expanding mission and its growing responsibilities. We’re the only advocacy organization that advocates for resources on both the food and medical products side of the FDA, as well as other parts of FDA’s jurisdiction. Our members include consumer groups, patient groups, research advocates, health professionals, societies, trade groups and we have about 160 members and continue to grow.
We welcome new members to further strengthen our advocacy and educational efforts or about the FDA. So, please consider joining the Alliance. As we start the new congress. Particularly as FDA’s responsibilities grow faster than its budget. For today’s webinar, we’re going to focus on FDA’s foods program.
We’re joined by FDA’s Principal Deputy Commissioner, Dr. Janet Woodcock. She’ll begin the program by summarizing some of the recent changes that FDA has announced. And some of the supplemental additional details about that plan. After her presentation, we’ll be joined by the Alliance’s Executive Director, Steven Grossman to interview Dr. Woodcock and ask some further questions. And then our co-moderators will engage in some questions submitted by the audience, as well as their own questions.
So, we encourage you to submit questions. Please do that using the Q and A button at the bottom of your screen. Please, do not use the chat function. We won’t be able to see that during the discussion, so use that Q and A button. So, I now have the privilege of introducing our guest for today’s webinar, Dr. Janet Woodcock. Of course, I think many folks on the phone know Janet. And I can’t begin to summarize her contributions to the agency.
But just want to say, thank you Janet for being here and we’re excited to hear from you. She is joined by her colleagues, Bill Tootle and Peter Reikes, who are available to help answer any questions that come up. And so, with that Janet, I think we look forward to your discussion and I will turn it over to you.
Dr. Woodcock: Thanks a lot, Tom and I’m delighted to be here. And again, I thank the Alliance for all its efforts on FDA’s behalf. We do have a very large remit and we do better by our stakeholders in general if we have enough funding to accomplish our regulatory mission. And that includes, I think the regulated industry. So, today’s discussion is about changes in the foods program at FDA. There’s been a lot of talk about this in the media already. We recently had an announcement about this. And so, I want to catch people up on where we are. When I rejoined the agency as Acting Commissioner a couple years ago, I immediately recognized the dire straits the foods program was in.
And I did try to increase funding for that program and did get small incremental increases for infant formula and other critical foods, really in the last couple appropriations to the agency. But there’s no doubt that this is a program that’s under-resourced compared to its very broad remit. Now, some of the recent discussions were precipitated by the infant formula crisis that happened last year, when one of the major players, plants had to shut down and initiate a recall, due to potential contamination. And shortages arose and they were very difficult to manage because there’s little resiliency within that market.
As a result, FDA did a lessons learned and issued a report about the infant formula and things that we could have done better during that episode. Subsequently, the agency was asked to do an independent expert evaluation of the foods program. And that was conducted under the auspices of the Reagan-Udall Foundation for FDA. And it was done by Dr. Jane Haney, who many of you may know, former commissioner. And a number of experts worked with her and produced a very robust and thorough report with recommendations about some significant changes to the foods program.
That came, I think in December and at the end of January, we issued an initial response to that, and then as I said earlier this week, another response. I just want to tell people where we are, where we’re planning to go and then hopefully, respond to a lot of questions. So, what was announced in January and recently is, that restructuring of the foods program is planned. Now, the foods program is comprised of multiple different units right now, OFPR and the Commissioner’s Office. The Office of Food Preparedness and Response. I’m not too good with acronyms, sorry. ORA has about 60% of the foods program by budget.
And then CFSAN, the Center for Food Safety and Applied Nutrition has the remainder of the budget. And then of course there is animal food and feed in the Center for Veterinary Medicine. And so, these multiple components have had to work together. And what was announced is that there will be a human foods program headed by a Deputy Commissioner, that will be over most of these activities. But CVM, based on the input from the stakeholders that we received, will remain an independent Center reporting to the Commissioner. But will be matrixed in on the human food areas, with the human foods program. And that ORA will remain an independent organization.
However, it’ll be under more of the strategic direction, budget direction and resource allocation direction of the human foods program and the same will occur because we’re considering the changes to ORA should go across the agency, that will be the same for all the other programs such as the device program, biologics, drugs and so forth. So, these are going to be major organizational changes to ORA.
It was also announced this week that we will be moving the cosmetic and colors program out of CFSAN. Now, an interesting anecdote about that is, many years ago when Fred Shank was head of CFSAN, and I was the head of CDERnd David Kessler was Commissioner, there was a desire by CFSAN to transfer cosmetics to the drugs program. And that didn’t go very well because they really didn’t have any FTEs, hardly. It had three FTEs, they were interested in transferring, along with the entire cosmetics program. And so, that program ended up staying in CFSAN, but it has never been a robust fit with the Center.
So, what was announced is, those programs will currently be under the auspices of the chief scientist, Dr. Bumpus. And they’ll be evaluating what to do, including all the new authorities that have been recently given to us as part of the omnibus.
So, those were the two major organizational announcements that have been discussed. It was also announced in January and further elaborated on this week, that we’re going to try to pull together most of the elements that deal with the state, local, tribal and territorial elements. And put them together into an integrated food safety system office. We’re also going to evaluate our international programs in foods and see if they should also be in that office. We give about $100 million a year, or probably more, we put towards our work with the states and tribal and local and so forth. As well as training and so on. And we leverage them tremendously in the number of inspections that they have done. and we really need to have a unified and coherent program there. So, that was announced as well.
Now, the other thing that was announced this week is that we have set up an implementation and change management group that will look at how to bring about how these different organizational changes should be done. And they will assist in actually implementing them and also change management. Right now, we have four workstreams set up under that organization, which I’m chairing. The implementation and change management effort. The first one is a budget workstream and Peter Reikes, who is on this webinar is co-leading that with Suzanne Roosen who is in OFPR.
And basically, that effort is to map the budget of all these different components to actual activities, such as how much effort do we spend, what’s the level of effort payroll and operating dollars on domestic inspections? How much do we spend on foreign inspections? How much actual investment do we put in these state contracts, cooperative agreements, training, all the activities we do with these state organizations. What percentage of the budget is that? Because of course, as many of you know who are in industry, one industry or another, it’s really very difficult to manage your program unless you understand how you are implementing your resources.
And you might ask, well how come we don’t know that now? And it’s because of the way the federal budgets are set up and appropriated. We can tag things more carefully, which is part of the project. So we can actually develop dashboards and figure out where our resources are going very specifically and be able to report on that. We’re also looking of course at the FSMA increases. Now, all those were used for FSMA-related activities, of course and a huge amount of progress has been made since 2011 by the agency, against all the FSMA expectations. But it’s really hard to trace that exactly to the dollars spent and where those dollars went.
And we’re asked repeatedly to provide that information. So, that’s one workstream that’s going on. The second workstream is trying to find all the elements that might be candidates for the integrated foods safety system office. And trying to bring all of those together. So, once we look at those and find out where they are, what people are associated with it, what resources and then figure out the work processes that’re associated with that, we can hopefully develop a design, an office structure for that office, that will be rational and non-duplicative and that will allow everybody to know what’s going on. So, that’s an important workstream.
A third workstream that’s under Dr. Bumpus is around the laboratories. We have heard some issues about collaboration amongst the laboratories, some issues with tech transfer. And we’re talking about the [inaudible] [00:15:10] laboratories, the [inaudible] laboratories and then the state and other laboratories that we work with. And so, Dr. Bumpus is looking into that. She’s uniquely qualified to help work on those issues and sort them out. So, that is ongoing. And I think we’ll yield a lot of useful changes and information. And then the final workstream, Theresa Mullen from CDER, along with Carol Cave who’s the Deputy ACRA in ORA are running a workstream on the inspection process.
And this takes a little bit of orientation, but for almost two years now, FDA’s been working on getting the inspection process across the agency, onto a workflow management platform. So that we’re no longer transferring information and data, requests for an inspection or inspection results, through email, SharePoint, Excel spreadsheets and all these things. In other words, so everyone is on the same page. And what they have started with doing is the inspection process itself and seeing if that can be done, piloting, doing that on a workflow management platform. Particularly, we’re using inspection protocols that have structured data elements and seeing if we can’t do that.
And so, one of them, is a pilot in the foods area. So, that is going on along with an inventory project, to try and rationalize, across the agency, the inventory of regulated facilities. And of course, this is uniquely difficult for foods. Because both the fact that farms do not register, even domestically we don’t have registration at farms. We have difficulty getting information from the states because every state is different. And also, because the import process poses unique challenges because not everything, all the foods that are imported are actually from registered firms. So, we’re working on all of that. And those are parallel projects to this other work that we’re doing.
So, those have been going on and they’re well into the pilot stage. What Dr. Mullen and Carol Cave are doing, they’re working on the requested inspection process right now. The Centers have prioritized lists that they send over to the field, using various methods, Excel spreadsheets, email and so forth. Then the field has its own work planning process that they do, that is not transparent to the Centers. Or even really, completely to ORA and it’s highly manual in its execution. And so, we would like to get a totally transparent, optimized process where everybody’s working together.
They do it once but it's also dynamic and everybody can see the results. And then that will be put on to the workflow management platform that we have. So, that’s the front end, we’re planning process reform. We think ultimately, we need to automate much of this using an optimization program. But at the moment, as I said, it’s done by hand. And multiple times. So, that’s Step No. 1. Then, Step No. 2 I’m doing with Carol Cave on the backend, which is the case workup. So, once a problem is found in a facility, what we would like to see is forming a multi-disciplinary team immediately. Having the investigator have access to the SMEs immediately, or [inaudible] [00:19:27] or whatever people are needing.
So that whenever evidence collection can be done efficiently, the right evidence can be collected. And then, not have a multi-step process to work up a case, if there’s going to be an enforcement action. So, that’s on the backend. Again that eventually, when the process is worked out, will be put on the workflow management platform, which we hope next year that we will be standing that whole thing up. So, that’s that workstream. Now, the implementation and change management group itself is taking on certain other projects.
For example, we have already agreed internally that the activities of the food program are primarily risk management and we need to have a unified risk prioritization process that is aligned with budget and strategy for the program, for every year. And that we should publish that, so that everybody on the outside knows what we’re going to work on, what we can’t work on due to resource limitations, where that cut line is. And we’ll be taking on how to figure out how you incorporate that into a new structure within this human foods program structure.
Additionally, we need to take on training. It is very clear the state inspectors need more training. They’re clamoring for more training. Our investigators need more training, they need more specialized training and so forth. The resources or the way we currently conduct the training does not enable that. In addition, we need to be able to train inspectors faster and if people come on with more advanced skills, we need to give them credit and move them through the process quickly. We’re currently down on inspectors. We’re just currently losing people through attrition and so forth. So, what you will see over the next several months, we pray we’ll be making many more announcements. However, we will at some point, announce the new structures that we’re envisioning in more detail.
We are limited by the fact that we have several unions. We have federal processes that we need to follow and so forth, so we can’t just go out and announce everything all at once. And we’re not exactly sure we have to really nail things down before we communicate about them. And communicate with the internal staff before we talk to the outside world. But Dr. Califf and I have been doing multiple stakeholder engagements and we’re very open to input about all of this and where we should go. So, Tom. I think I’ll stop there.
Tom Kraus: Thanks. Thanks, Dr. Woodcock. So then, let me invite Steven Grossman, the executive director of the Alliance to join the conversation.
Steven Grossman: Thank you. Thank you, Dr. Woodcock. It’s always a delight when you join us, and we always come away better informed. Before we get into any of this, I just hope that everybody in this audience appreciates that this is literally thousands of hours of systematic and systemic attention to food programs. That’s never occurred. You’re producing valuable numbers, for example, that nobody’s ever collected, nobody’s ever analyzed. And so that, whatever results from this, there will be, the information to move forward with intentionality about what the common goal is.
An organization has been created with a goal and a structure to be excellent. And I think that thousands of hours will be something foods never had and will l make a difference. I did want to mention that the Alliance exists to advocate for the resources that FDA needs to assure Americans that they have a safe and nutritious food supply and safe and effective medical products. We have taken the position that food reform and increased funding for food programs are intertwined.
We do not support specific ways of achieving that reform, just that spending the money needs to be done appropriately and with transparency and accountability. And with that, I’m going to launch you into a question here. There seems to be universal agreement that human food programs were uncoordinated, inefficient and ineffective. What have you and Commissioner Califf seen as the primary problems to which a direct and forceful response was needed?
Dr. Woodcock: Well Steve, and I like your comment about intentionality of organization design. Because that’s very important. First of all, let me say I think the programs have been relatively successful. We have safe food in the United States. We have put out a number of nutrition initiatives and so forth, like menu labeling and so forth over the years. And so, it isn’t as if this program has failed, it’s that it is struggling against a lot of organization obstacles that we think can be streamlined. And I think the reason that those occurred probably are historical. These programs seem to have been assembled more by aggregation than by intent.
And so, if you look at underlying causes, you start with what you want to accomplish and then how do you accomplish it? And then you design a process and so forth. Pretty soon, it is very difficult in this program, I will say, to understand who’s on first. And I do see a lot of independent actors, people with great ideas going forth and trying to implement those ideas without the systematic buy-in.
And so, this program is doing this initiative and that program is doing that initiative. Or working with that outside stakeholder group. And so, it is very confusing, I think both internally and externally. I will stress, the staff are extremely dedicated and really dedicated to the mission. It’s not really the staff, I think it’s the system that they’re in.
Steven Grossman: Well, I can attest to that on one level. Every time the Alliance has run a food program, I had to sit and think about who to invite. So, often very unclear. To what degree have there been problems in existing human food programs, and what has been effective but underfunded? How much money does the FDA need and how soon, in order to rectify the organization? And what’re your priorities within that funding request?
Dr. Woodcock: Okay. Well, there are several different sets of problems, okay? And I don’t think until we sort out this organization and the budget, we’re going to be able to answer those questions quantitatively. So, let me give you a qualitative answer. No. 1.) I’m not sure we’re leveraging our regulatory partners adequately. In other words, the states, territories and so forth. And clearly, according to them, we’re not training them enough. They’re lacking in the training opportunities that they need. So, that’s clearly one issue.
The second issue would be, to what extent in the field, do we need more boots on the ground, inspectors in the foods area, okay?
So, that’s another one. The third one is, and I don’t know this is a financial issue. It’s something else we’re working on, and we did announce, we’re going to be moving some of the IT development from ORA into our ODT, into our CIO’s office. And also, into our enterprise transformation office. So, right now we’re dealing with obsolete IT that does not talk to each other and people in the field have specific problems. To an extent, this is a money problem, to an extent this is a design problem. I think there are a lot of design problems in it. Question is, it’s probably going to need money to fix, regardless of how we got there, right? So, that’s something.
And then, if you talk about the scientific food program, say the chemical contamination side of the house. That’s clearly under-resourced. And also, the nutrition side. When I took over as Acting, I think there were three people working on infant formula. And that’s why I asked for an increased budget in that area, because leaving aside the production problems and contamination problems, lots of companies want to have novel ingredients in infant formula, right? To more mimic breast milk. However, those are biologically active components and we have to be really careful. And it’s just a pre-market notification program.
So, we have got to have people who really, are at the top of their game to be looking at that. Because lives are at stake or quality of life for infants. So, both the chemical contamination space and I think, the nutrition space are also really under-resourced. But the magnitude of that, I can’t really tell you right now. Pretty significant.
Steven Grossman: Thank you. Now I’m going to get to the question you know I need to ask. ORA is about two thirds food, 60 to 65% food. One of its criticisms so far has been that your plan does not give full accountability to the new Deputy Commissioner, or a unified foods program. In particular, how do you envision that the Deputy Commissioner would have control over food inspections, if he or she does not have line management responsibilities over inspectors?
Dr. Woodcock: Yes, well let me echo Rob Califf, because I think he has a really nice take on this. Modern organizations aren’t like kingships. Or monarchies, right? They’re matrix organizations. They have accountability built in, and we will build in accountability. People have not seen the full re-org package or the re-org proposal. They’ve only seen really, the top levels of it. Certainly, for ORA, as I’ve said, we’re going to go across ORA and modify things significantly.
And it will be for medical products, as well as for foods. And the goal there is to have the foods program in ORA really be a part of the team, the food program team, as well as the drug people in ORA be part of the pharmaceutical team and so forth, so that they work together. But as we announce the Deputy Commissioner for Foods will have financial and strategic oversight or direct direction over how those resources are used in ORA. So, that’s how we’re going to do it.
Steven Grossman: Thank you. The timeline suggested by Tuesday’s announcement would have submission of the reorganization, by the fall. How will the food programs be managed until the reorganization occurs, and how will you avoid perpetuating existing problems?
Dr. Woodcock: Well, those are two really different questions As people may know, some people on this call, I’ve overseen multiple, huge reorganizations in the drugs program. That involved thousands of people and involved doing things in completely new ways, like when we set up the new generic program and the new quality office. And a totally new IT system for generic drugs, when we first got the generic drug user fee program. So, all these things are doable, they’re just hard. And, so it’s going to be hard to keep running the program while we have to put a re-org package through multiple different venues and get permissions and so forth.
It's going to be hard to keep that program going, but we must do it. That’s our job. And so, we have to figure out ways to keep the program on a steady course and improving, while everyone knows we’ve submitted this big re-org package and things are going to change. So, that’s just the reality in the federal government, of how we do things. Now we’re not going to fix all the problems in this process. We have to pick our battles and then do them well. And Steven, I like what you said about intentionality because I’m of course, in line with that. I want to fix the systemic problems. I would like to devise an org design that can continue to improve over time.
And who has the mandate, has the ability, you know who’s in charge of doing that, right? And just continue to improve over time. Because no organization should be static and we shouldn’t feel that we set this up and it’s perfect. What we need to do is set up an organization that is capable of evolving, because everybody knows, people know who’s in charge of that.
Steven Grossman: That’s back to intentionality now.
Dr. Woodcock: Yes.
Steven Grossman: That’s really, really important. Okay, I have a last question, so the co-moderators are on notice here, we’re at our last question. On March 9th, the President’s FY-24 Budget Request will be released. Will the text for the budget for the food program reflect, thinking from last summer and fall, when most of the budget was already decided or have you had the opportunity to update the request to the most recent thinking? If you’re not updated, then when can stakeholders expect guidance on your actual food safety request?
Dr. Woodcock: Well, Bill Toottle is on, and he can explain how the federal budget works. We can’t really modify things all the time as it goes through the process, but I think what we put in is pretty much what our priorities are. But when we send the re-org package and we have to send a reprogramming request in along with it, that switches all the resources around too, Bill?
Bill Tottle: Yes, I think you captured it right. We can’t talk too much about the FY-24 Budget until it’s actually released by the President, which will be next week. But we did make sure we’re consistent with what our needs are, going forward.
Dr. Woodcock: Yes.
Steven Grossman: Well, since the Alliance wants that information, let me just say, if another session is a good idea or however else we can approach this, we need to know how to reconcile what’s said with what we’re planning. So that money follows that intentionality in creating an excellent program.
Dr. Woodcock: Okay.
Steven Grossman: On that note, co-moderators and thank you, Dr. Woodcock.
Tom Kraus: So Sara, why don’t I suggest that you go ahead and start, and then we can just take turns and I’m just going to ask that you all just stay on camera so that we’re not hopping on and off.
Sara Sorscher: Sure. Thank you so much for this opportunity. Dr. Woodcock, we’re now approaching the six-month anniversary of the Whitehouse Conference Report on Hunger, Nutrition and Health and of course the FDA’s food program had a number of priorities announced in that report, including front of package nutrition labeling and more work on sodium and added sugars reduction. And I’m curious to hear your assessment of how the program has fared in the past six months and how the re-org might impact FDA’s ability to meet its commitments under that report.
Dr. Woodcock: Well, those initiatives are front of mind. As you know, our Commissioner, Dr. Califf is very concerned about common chronic diseases. And so, some of those really play into perhaps, levers that we can pull to modify morbidity of the population, based on nutrition. So, we are trying to move ahead on all those. And certainly, I think the reorganization proposal will elevate and recognize with the Center for Excellence in Nutrition and so forth, the importance of the nutritional aspects of what FDA does. Because I know a lot of federal agencies are involved, the Department of Agriculture has a big role. CDC and so forth.
But we have unique levers that we can pull with labeling and so forth. And I think the sodium initiative, we’re going to have to do a lot of surveillance to make sure, to see to what extent there’s some voluntary compliance with that and publicize that and so forth. So, there’s a lot of work to be done, as I said, the resources are pretty strained there. But I’m extremely interested, and the Commissioner is very interested in making sure these move along promptly.
Sara Sorscher: Maybe, can I dig in because you mentioned resources. It’s been estimated that about six to seven percent of CFSAN’s current budget is spent on nutrition. In your work so far looking at the budget and the new center, do you expect – do you think that number is still accurate and do you think all of that will flow into the new center, or do you think it will be higher, lower?
Dr. Woodcock: I don’t know. I mean, we don’t know the answer to that because of our problems with sorting out the budget, but it’s a very low percentage. And we certainly don’t mean or don’t intend to take away any funding. But this re-org proposal does not bring us any new money. And so, we’re talking about a zero-sum game here. Many of the prior leaders of the program and the Commissioner’s Office have been food outbreak folks, food safety folks. So, that was where a lot of societal attention was paid and FSMA as well. But I think now, we’re trying to have a more balanced portfolio, so certainly the goal will be to try and build up that program.
Sara Sorscher: Wonderful, thank you.
Donna Garren: Thank you, Dr. Woodcock for joining us today and thanks to the Alliance for hosting you today, to share a little bit of your thoughts about reform. It’s much appreciated by those that are stakeholders. Will the reform that you plan to outline impact the relationship between ORA and CFSAN? And what would be some of the key challenges they’ve experienced between the two organizations. And how does the reform seek to address these challenges?
Dr. Woodcock: Well, one of I think the big changes is, first of all, CFSAN is going to be subsumed, as you know, into the human foods program. And that human foods program will have the integrated food safety system as a separate component of it, an office within that program. And so, that will pull a lot of things that are in ORA, we don’t know exactly all the components. But it will pull them into that system, okay?
The second thing is, all this work that we’re doing on the inspection process, hopefully will modify – no, I shouldn’t say hopefully because it will modify the relationship and bring the inspectors much closer to the SMEs, hopefully make our enforcement actions much more speedy and much clearer to everyone. And hopefully, will generate some resources by reducing duplication in those programs. And ultimately, with automation, will actually give us much better sources of data. There will be a single, strategic plan for every year on laboratory sampling. And the surveillance and how that’s done, instead of having different plans.
So, we’re going to have a unified program that we’ll plan at the beginning of the year, what they’re going to do. Responses to emergencies, we’ll have a clear lead and that’ll be very clear to everyone and should not be a problem. And we set all that up with that intentionality in the organization design, so that it isn’t a problem for people, it flows smoothly. So, I think there will be major changes in the relationship between ORA and the foods program, and frankly, all the other programs in the FDA as a result of this.
Donna Garren: Thank you. Thomas?
Thomas Gramillion: Thank you. Apologies, I lost my connection there for a second. And it sounds like Donna, you may have preempted my question. Dr. Woodcock, it’s a pleasure to be here with you. I’m sorry, I missed a little bit of that but you peaked my interest when you mentioned that the Deputy Commissioner for Food will have the budget authority and strategic direction over ORA. And I wondered, what’s the role of the Director of ORA?
Dr. Woodcock: Yes.
Thomas Gramillion: And you could just spell that out a little bit.
Dr. Woodcock: Right. Well, right now the Centers have ostensibly a lot of strategic direction over ORA and so forth. But it can’t be substantiated very well because of the systemic problems that exist. The head of ORA really needs to, we’re going to make ORA a leaner organization that is focused on its core capabilities which was inspections, the laboratories as well as sampling, the border, criminal investigations and other investigations. Those things that’re uniquely ORA disciplines and capabilities. But the strategy for how to run a program, whether it’s the drugs program, right? Or the foods program or whatever, really resides with the program.
For example, what are the concerns this year? What will we sample? What will we target in a year, and so forth. How many inspections will we do? Right now, the inspections are directed by the Center, however due to the problems in the work planning process, nobody really knows what’s going to get done, all right? And so, we’re going to try and fix those things. So, part of it will be making clear who has the decision capability. And part of it will be designing the processes and workflow systems that enable these things to actually happen.
Thomas Gramillion: And a follow up question to that, given all the challenges with ORA’s work processes, why do you see so much value in keeping ORA together and you’re getting all this pushback for not moving ORA under a Deputy Commissioner without it.
Dr. Woodcock: Right, well that’s because those people don’t have to then, wouldn’t have to run that program, okay? Okay, if we keep ORA together we can do one reform of the processes, right? Rather than do seven. For example, okay? And these are logistical issues, so running the laboratories, right? There are many common things, there’s a laboratory management information system. There’s ordering. There’s training on instruments. There’s this, that and the other. There’s credentialling of the scientists. There’s maintenance of the laboratories. There’s a laboratory safety system. Do we really want to duplicate that seven times by splitting up ORA to, same with inspectorate.
There’s a base level of training, of knowledge and procedures that you go through. Whatever kind of inspection you’re doing. Now, this specialization and specialized inspections, that is shared with it, the Centers as far – the Center experts, as far as what should be looked for and so forth. But I think the people who frankly, I think the people who are calling for this really haven’t operated a large organization at a very detailed level, which I have done numerous times, all right? And I just really feel like we shouldn’t be doing an old-style organization. We should be doing a modern matrix organization, so we get the most bang for the buck for the tax payer.
Thomas Gramillion: Thank you. I know we have some audience questions. I actually don’t have the audience, because I was kicked off of here, I’ve lost the audience question but maybe Sara or Donna, you could.
Donna Garren: Sure, I can. Helena, is asking, can you talk about what response you’ve gotten so far from lawmakers. Specifically, appropriators on the re-org plans. And are you concerned that the Hill is going to have different ideas about what you should do?
Dr. Woodcock: Well, we have a whole process of, at the end of the day, notifying the lawmakers, including the appropriators. And we have to get their concurrence with this, basically, as the notification process. But we are planning to keep them informed all the way along. They’ve heard a lot of things from the stakeholders, many of the things you’ve brought up already. And we are listening to all those things, but really, we think this perception on certain things is not all that helpful on really doing an intentional organization that’s going to function very well. But Bill Tootle is on and he can talk about a relationship with the appropriators. Bill?
Bill Tottle: Yes. So, we will be having conversations with the appropriators, once we release the ’24 budget and letting them know how that relates to these reforms and start to talk to them some more about what to expect down the road. But we won’t be submitting the actual notification package for a little while now. We have got to make sure we think it through and come up with the right plan, for the right structure. And then we’ll submit it to Congress and have further discussions with them.
Dr. Woodcock: Yes. Yes, I think many of the stakeholders and particularly those who are talking to the Hill are, once you hear more about the details of the plan, many of your concerns will be addressed. But we can’t release all those until we’ve gone through the whole process of talking to the staff and talking to everybody and doing the internal due diligence. But I think this concern about lack of control over the whole program and strategy, resources and so forth will be assuaged when people see the entire design.
Sara Sorscher: I have a question from the audience about dietary supplements, what’s going to happen to ODSP in the new re-org strategy?
Dr. Woodcock: Well, dietary supplements are regulated as food, and so they’re staying with the foods program. That’s another program that is under-resourced for a very large industry that has now grown up in dietary supplements, right? However, as I said, this is a zero-sum game. We’re not getting necessarily more resources for these programs. So, I think we’ll just have to make sure the dietary supplements are covered properly in the program, but they’re staying in the foods program. I will say, the manufacturing of dietary supplements has a little bit more resemblance to pharmaceuticals, than it does to foods. But most, many of the dietary supplements anyway.
Sara Sorscher: It’s certainly a program with unique challenges. Folks can continue to put questions in the Q and A and we’ll keep monitoring them. I have one around strategy, I think you’ve talked about how the re-org is going to allow for some broader food program level stratification. There are a number of strategy documents that’ve been released in recent years. Closer to Zero, New Era for Smarter Food Safety.
Dr. Woodcock: Right.
Sara Sorscher: How do you think the re-org is going to impact those strategies? Will the agency continue to use those as its guiding star for the next few years or do you think that there will be a re-think on some of those?
Dr. Woodcock: No. But I think there are components, if you know what I mean. So, the New Era of Smarter Food Safety. There are different things that could be done, for example as far as food outbreak tracebacks. There are some other things that’re going on, under that New Era of Smarter Food Safety that will continue. We’re experimenting with machine learning at the border to figure out if we can target violative imports better. That’s a really good thing to do. Closer to Zero is an initiative but again, it is a strategic initiative related to certain elements in food, right? It isn’t a total food strategy. So, what we hope to do is bring all these together.
I mean, there have been several documents released on imported food, too. Imported produce and so forth. And our strategy there. But hopefully, we will have a unified strategy for the whole program because strategy is one thing, but how much money, how many people. What resources are we going to put down on Closer to Zero? How many resources do we put down on say, import machine learning pilot, for example? These are strategic decisions that have to be made and should be made and be transparently made every year.
Donna Garren: Dr. Woodcock, this is a question from the audience. Who is leading the Office of Integrated Food Safety Systems partnership development workstream and how is that process going, in regards to impacting the funding at the state level inspectionactivities?
Dr. Woodcock: Okay, I won’t talk about who’s leading them right now.
Donna Garren: Okay.
Dr. Woodcock: We will release that, okay? As I said, right now we’re just trying to figure out who is playing in this space. And there are lots of players, there are lots of cooks in this kitchen. And then we’re trying to figure out how much money all the different – through the different initiatives and so forth, cooperative agreements, contracts, other initiatives. How much money and resources are we spending on this activity? What are we getting out of it and how can we make it into a coherent strategy, that we all can understand and agree upon.
And it becomes well tracked. And then, we can figure out, as we put it against, say Closer to Zero or imports at the border, right? Where do we put our resources next year? How do we formulate our budget? What do we ask for increases in? All these programs could need more money, so strategically, where do we want to get the most bang for the buck? So, that’s what we’re going to do. And right now, we’re still in the, what I call the archeological stage where we’re trying to figure out where everything is.
Tom Kraus: I think we have time for just one more question.
Thomas Gramillion: We’ve got an audience question about how the ORA changes will affect medical products inspectionsWhat do you foresee there? Do you expect the re-org to allow enforcement to be more aggressive or accomplish more?
Dr. Woodcock: Yes, we plan to do that part, the inspection process modernization around the entire agency,
across all of ORA and all the regulative products. And we expect that, No. 1.) There will be more transparency on the work planning. No. 2.) We’re going to get on a new platform, hopefully next year for inspections. Where they’ll be available in that platform, to everyone in the FDA, rather than in where they are now. And then, enforcement and case management efficiencies will come on the back end and that’s what Carol Cave and I are working on. And yes, it should go across all the different commodities. We’re going to streamline and reduce duplication and we hope, the plan is this will lead to more efficient and effective actions.
Tom Kraus: Great. Well, thank you Dr. Woodcock. Thank you Bill and Peter, for joining us as well and all the work that each of you are doing on this effort. Thank you to our moderators and Steven for participating in the interview. With that, I just want to thank you. We look forward to more information to come on this effort, and of course the Alliance will be advocating for resources, for FDA for implementation of the foods program, and other programs within the agency. So, thank you very much for participating in this. There will be a transcript of the discussion that will be available in a few days for folks to be able to review. So again, thank you very much and appreciate your participation.
Dr. Woodcock: Thank you Tom and we’ll be certainly happy to do this again at some point and get the word out when we’ve made progress.
Tom Kraus: Thanks, Janet.
Dr. Woodcock: Okay. Thank you.
Donna Garren: Thank you, Dr. Woodcock.
Dr. Woodcock: Yes. Happy to do it. Take care.
[End of Audio]
Duration: 58 minutes