Acting FDA Commissioner Dr. Janet Woodcock spoke recently to the Alliance for a Stronger FDA with some assurances for the food safety side of her house.
The acting commissioner for the Food and Drug Administration brought up the issue herself, asking: “Is there a risk with COVID and all of the breakthrough drugs coming along and so forth? Will food safety and veterinary medicine budgets will be neglected?
“My answer to you, and I tell you this very sincerely, is not on my watch, “ she said.
Her remarks came before an audience of more than 200 stakeholders in the agency’s priorities for 2021 with a particular focus on its data and technology modernization plans.
As for neglecting food safety, however, Woodcock, a medical doctor, said “that absolutely will not happen on my watch.”
“I believe that we have to invest in every program,” she said. “Every program that the FDA has is important. It affects all sectors. Animal health, for example, affects many, many people and so forth.
“Food safety is a critical public health issue. So, we are not going to neglect those, and I am already getting myself up to speed on what we need to do. For example, we just issued the baby food action plan, ‘Closer to Zero’ and I think you will see more activity on our part in the various components of food safety.”
Ronald J. Bartek, president of the Alliance for a Stronger FDA and co-founder and president of the Friedreich’s Ataxia Research Alliance credited Woodcock for her appearance.
“Unlike presidents, FDA commissioners do not typically participate in wide-ranging press conferences. When the commissioner speaks, it is usually to a restricted, specific audience or is limited to the issue du jour facing the agency,” he said.
“Perhaps the only exception occurs when the commissioner addresses the Alliance for a Stronger FDA — a coalition of 150 organizations representing the entire gamut of the FDA’s stakeholder groups. It is that rare space where commissioners can talk about anything they wish to address and answer questions from the membership of the Alliance representing the entire spectrum of the agency’s stakeholders.”
Between pre-submitted and audience questions, Woodcock covered more than a dozen topics over 40 minutes including:
- FDA’s Long-Term Budget Priorities. FDA’s main budget priority is “to have adequate funding to keep up with its obligations.” Noting that “across the agency, there is an ongoing resource strain, more severe in some programs than others,” Woodcock pointed to making programs more efficient, agency modernization, and public safety and health as three areas of focus.
- Plans for the $500 Million in the Recent COVID Relief Bill. From these monies, the agency will spend “a significant amount on surveillance.” This is both for pre-market and post-market surveillance, but also active surveillance on products marketed under EUAs. FDA is also going to invest in supply chains, advanced manufacturing, and recovery plans that address areas (such as inspections) that have been thrown off by the pandemic.
- Major Programs to Be Implemented in 2021. “Our tech modernization is really major, both the data modernization and the infrastructure modernization. What are we doing? We are going to try to have enterprise-wide platforms and common data standards so our systems can talk to one another and we are not paying so much for individual siloed platforms.” This is an agency-wide need that encompasses both food and medical products programs. In particular, the New Era of Smarter Food Safety initiative is built on “more informatics and modern infrastructure that looks at both distribution of foods and also is able to pinpoint risks better.”
- Agency Morale and an Overworked Staff. “The [government-wide] employee viewpoint survey was conducted in November and FDA employees at that time. . . had extremely high morale.” In a crisis, “people with public health orientations step up to the plate…and they give it their all. So, we have that kind of esprit de corps.” She added: FDA staff “are very proud of what they have been able to accomplish. . . and I am very proud of that.”
What follows below is the transcript of Acting Commissioner Woodcock’s remarks. A video with the Q&A session from the event can be accessed here
Thanks so much, Ron, and hello, everyone. I am really delighted to be able to talk to this group and have really appreciated the outstanding support over the years. It is really critical both for the patient and consumer community that we have a strong FDA. So, what I decided to do since the team sent me a large number of questions that many of you submitted, I decided to have a Q&A with myself so that we can go over many of these questions as part of my presentation, and then leave ample time, as we said, for further discussion on whichever ones there are additional issues to be discussed. So, let me just get started.
The first one was what are our long-term budget priorities? Well, clearly, from my point of view, the FDA needs to keep up with its obligations and we need to have adequate funding to conduct those, including modernization efforts. So, across the agency, there is ongoing resource strain, more severe in some programs than others. So, our goal needs to be to make sure, through whatever means improving efficiency – of course, I have always been a proponent of – and modernization, as well as having adequate resources to conduct all of the different programs that support public safety and health. So, particularly, I share with you the interest in modernization, both of our IT infrastructure as well as data modernization. I will get into that in a little bit more detail.
So, another question, has the agency’s budget kept up with the demands put upon it? No, we have inflationary costs that are difficult to explain to everyone, both on the payroll side as well as the capital side. We have deterioration of facilities that need to be upgraded. Anyone who owns or manages facilities understands there has to be ongoing upgrades and investments. We cannot write off depreciation like the private sector.
What are our plans for spending the $500 million from the recent COVID relief bill? We were really happy to get that. We are going to spend a significant amount of money on surveillance in both continued pre-market work that has to be done for many things coming along. Things that are EUA are not fully on the market, obviously, and more interventions continue to be tested. Then, things that are on EUAs, their surveillance must be stepped up and kept active across all three commodity areas, the devices, drugs, and biologics, the vaccines.
Of course, we have issued some guidance and the variants are beginning to impact the therapeutics and a little bit of the diagnostics right now. Fortunately, the vaccines are continuing hold and we hope that continues to happen. We also are going to invest in the supply chain. One of the things that this pandemic made very, very clear is that we do not have enough insight and visibility into various supply chains. We have received some monies to do this, but we have received additional within this supplemental, and we plan to invest.
Much of this is IT-driven supply chain issues. We also plan to invest in advanced manufacturing, which also has to do with shortages, the need for surge capacity, and advanced manufacturing. Particularly, we are looking at vaccines, mRNA, and so forth. The need for surge capacity in a pandemic is obviously very clear and these advanced manufacturing techniques are actually what can be searched rather quickly compared to traditional manufacturing. So, we were very grateful that Congress gave us these monies.
We are also going to be using some of the money for recovery because, as many other questions ask, “how are we managing when we have COVID on top of everything else?” The answer, I think, that some things had to be put off, such as some inspections and so forth, and we need to have a recovery plan.
What major programs are you working to implement this year? Well, our tech modernization is really major, both data modernization and infrastructure modernization. What are we doing? We are going to try to have enterprise-wide platforms and common data standards so our systems can talk to one another and we are not paying so much for individual siloed platforms.
Is there a risk with COVID and all of the breakthrough drugs coming along and so forth? Will food safety and veterinary medicine budgets will be neglected? My answer to you, and I tell you this very sincerely, is not on my watch. That absolutely will not happen on my watch. I believe that we have to invest in every program. Every program that the FDA has is important. It affects all sectors. Animal health, for example, affects many, many people and so forth. Food safety is a critical public health issue. So, we are not going to neglect those, and I am already getting myself up to speed on what we need to do. For example, we just issued the baby food action plan, Closer to Zero, and I think you will see more activity on our part in the various components of food safety.
Now, again, one of the questions, are we staffed at a level that allows us to carry out our critical public health mission? Well, it depends on how thoroughly and how people wish us to want to carry out that mission. We have been criticized prior to the pandemic, for example, for our lack of conducting foreign inspections. We do that to the ability of our resources, so the more we have, the more we can do. So, it is not like a black and white issue. It is kind of a sliding scale of we do as much as we can, as effectively as we can with the resources that we have.
What type of staff are 2021 hiring priorities and are they different between medical products and food safety? I think that is a little too complicated to go into the 10 minutes. We are hiring where we have vacancies and where we can get people in. Yes, 21st Century Cures, that has been another question – that has been a tremendous help, I think, in both hiring and retaining staff in the areas where it is applicable to the medical product areas. So, that has been a very important tool enabling us to retain staff.
How would I characterize agency morale? Well, it is difficult to say in general, but there was a federal survey that is done every year. The employee viewpoint survey was conducted in November and FDA employees at that time, which was right in the middle of the pandemic, had extremely high morale. I would attribute this, despite the fact that they under awful strain and workload in some of the programs, to the fact that during a crisis, people with public health orientations step up to the plate and they feel like this is what they were born to do and they give it their all. So, we have that kind of esprit de corps.
We have sent a lot of people down to the border to help temporarily with the unaccompanied children, and I have been hearing from them how inspiring that is and how happy they are to be able to help. We will not have a big drain on our resources from that, but we have temporarily sent a lot of people. It is the same phenomenon. They understand there is a tremendous public health need and they are able to step up and fill it.
So, I would say our staff is weary. Many of the people, say in the medical products centers, are weary with all the work and it is more problematic in some areas than others, obviously, but I think they are very proud of what they have been able to accomplish and I am too. I am very proud of that.
So, the data modernization plan, tech modernization action plan, we got a lot of questions about that. How dependent are we on legacy software and what are some of the problems and lost opportunities? Well, it is a very painful subject, so if I have a sour-looking face… Basically, we really have very high-cost systems where we do not get the return on investment that we need. We have a lot of systems that are legacy systems. They were built for one purpose. They may have been very highly customized or purpose-built rather than off-the-shelf. They do not talk to each other and they cost a tremendous amount in maintenance because we have so many of them.
So, the operations and maintenance costs are significant and some of them even have lost support by the original vendor because they are so old. So, we are spending a lot of money. We are not getting that return. So, what we need to do is really build enterprise-wide platforms using available, off-the-shelf software that we can utilize across the agency, and then transition these processes and databases and everything onto those platforms. The data modernization plan then will have an enterprise-wide data strategy.
So, with modern computing, you do not need to have the exact same system doing everything. They can talk to each other as long as the data are somewhat compatible so that you have links. So, we have just formally kicked this off. I was at the first meeting of the Data Council. The good news from my point of view, organizationally, is I think everyone gets this and we have Amy Abernethy, who has built a strong central group to manage these programs, and we have a method to move forward now. Everybody sees the fact that we cannot continue the way we have been doing.
So, what are the budget and human capital requirements? Well, I think that is simply the usual. We have asked for more dollars to support these plans, and hopefully, we will get some support on that. Now, someone said what are the benefits to food safety, that is harder to see, and actually the New Era of Smarter Food safety is mainly informatics, the data type of initiative where we get information and can apply modern analytics to figure out risks, to pinpoint problems, and to figure out trace-back in a rapid manner because right now when we have a food outbreak, it is really very difficult for us to figure out where the food came from and it is not timely. So, I think food will be beneficial.
One of our initial driver projects in data modernization relates to the food program and the animal drugs program. So, what about AI is the question? Could that provide a fundamental role in transforming our regulatory activities? Yes, but first of all, you have to have data that the AI can work on, so that is where the data modernization goes. If we could target risk for imports so we could figure out with a smarter intelligence than humans what to target, that would be terrific.
So, inspections and program initiatives, what are we going to do to catch up? We will be putting out some more information on that probably very soon, so I do not want to talk about it here.
Are there key differences between medical products and food safety? Well, mainly, the differences in medical products, we have some applicants whose applications have been delayed because of the lack of inspection. So, we will look at that and how we can recover very quickly from that. Otherwise, this story is fairly similar across the agency.
The New Era of Smarter Food Safety, how can we promote this and get support for it? Well, I will seek your support. We need to flesh this out, have specific initiatives that we do overtime, but really it is to have more informatics and modern infrastructure that looks at both distribution of foods and also is able to pinpoint risks better. Then, use, of course, which we are doing of modern genomics and so forth, can we get that to a higher level? Cell and gene therapy is the most pressing resource need, yes, and we are aware of that and everyone is aligned with the fact that that field will probably explode. We hope so because people with rare diseases and genetic diseases and some cancers will probably benefit tremendously from this field in the short term.
Shortening supply lines, people ask what role does advanced and continuous manufacturing plays. I have been supporting this for years and FDA has. Well, obviously, continuous manufacturing for APIs, for example, can be done, say, in the U.S., and the U.S. government has put out some contracts in supporting that right now. The intermediates, the chemicals that go into that, are a different issue. They are usually made all around the world and that is where supply chain management and trying to figure out where critical components come from will still be very important, even if we establish an advanced manufacturing base in the United States.
How did we manage to fully address COVID as we have and still fulfill the rest of our public health mission? Well, I think it is by many of our staff working 24/7 and although their morale is high, were very tired. How can improvements in technology and data be leveraged to respond to future public health crises? Well, from my position where I was at Warp Speed, we are conducting lessons learned across all the U.S. government sections, at least for therapeutics, so that we can figure out the more efficient ways to do things, where could we plan better, construct better infrastructure that could respond faster. Even though we actually managed to respond very well, we could have done better. You can always do better. So, we are doing a lesson learned.
How do I envision FDA being different or better in five years? Well, for all the commodity areas and all the things that we do, we are seeing increased scientific sophistication, increased use of information and data, and so forth I would see that we hopefully can move most of our things to the cloud. We can automate many tasks. So, our scientists and other staff are working on things where they really can contribute and they do not have to do a lot of busy work and we can rise to the challenge of all these new technologies that are being developed everywhere from foods to medical devices. So, thanks very much, and I will open it for questions.