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Press Briefing by Senior Administration Officials on the National Biodefense Strategy

September 18, 2018

Via Telephone

12:32 P.M. EDT

SENIOR ADMINISTRATION OFFICIAL: Good afternoon. Thank you all for taking the time to join us. A short time ago, the President signed the National Biodefense Strategy and an associated national security presidential memorandum to create a new interagency process with respect to biodefense.

It's appropriate that the President did this today on the 17th anniversary of the anthrax attacks on Washington. Moreover, in this centenary year of the great influenza pandemic of 1918.

Originally, the administration was directed in the Fiscal Year 2017 National Defense Authorization Act to develop a biodefense strategy between the Department of Defense, the Department of Agriculture, the Department of Health and Human Services, and the Department of Homeland Security.

Upon undertaking the review consistent with the congressional requirement, the administration determined that we were actually looking at a far larger problem set. We determined 15 different departments and agencies, plus the intelligence community, were involved in the key efforts to look across all possible sources of a biological incident, whether natural, accidental, or deliberate.

The National Biodefense Strategy covers all geographic areas, and it covers all targets including humans, animals, plants, and the environment. And it looks across five goals and associated objectives.

It will assess biological risks, ensure capabilities to prevent biological incidents, prepare to reduce the impact of biological incidents, respond rapidly to biological incidents, and recover after biological incidents.

What the strategy does, is it determines a new role for the Assistant to the President for National Security Affairs -- the National Security Advisor. Each year, the National Security Advisor will coordinate the development of a joint policy guidance on priority areas of biodefense, as informed by a U.S. government-wide biodefense assessment.

The strategy, for the first time, appoints a lead Cabinet-level official responsible for coordinating the implementation of biodefense across the interagency, and that will be the Secretary of Health and Human Services.

We will annually -- based on the guidance generated by the Department of Health and Human Services and the interagency, we will look at the priority areas for biodefense across departments and agencies, and include recommendations for the budget request to support the implementation of this strategy.

With that, I'd like to turn to [senior administration official], to provide any remarks he may choose to make.

SENIOR ADMINISTRATION OFFICIAL: Thank you very much. And it is a great day. And I just want to convey Secretary Azar's delight and excitement to be part of this signing ceremony with the President just within the last hour.

I think to just reiterate a couple points that my colleague has made in terms of the nature of this document, I'll just read from the first line, which -- it says, "It is a vital interest to the United States to manage the risk of biological incidents," which gives you a sense of the priority that the President and the administration has put on this topical area. And to my colleague's point, this covers the range of naturally accidental and deliberate threats that could result from a biological incident that could emanate from individuals, non-state actors, or states.

The role of Health and Human Services to implement this strategy is a significant one. And working with our partners at Defense, in the Department of Homeland Security, and the Department of Agriculture will lead an aggressive month-long -- pardon me, 12-month-long effort to basically implement the strategy and report back to the National Security Advisor on the area that my colleague identified: The five pillars, which are risk awareness, prevention, preparedness, response, and recovery.

The last thing I'll point out -- and this is an the area that is significant in this strategy -- is also the role of innovation as it relates to the opportunity for engaging the private sector and the state and local entities to seek for opportunities to basically leverage emerging biotechnology and biopharmaceutical innovations to basically assist not only in defending our nation, but making our economy stronger and more capable.

With that, I'll stop and turn back to my colleague.

SENIOR ADMINISTRATION OFFICIAL: And [senior administration official], for any comments he may choose to make.

SENIOR ADMINISTRATION OFFICIAL: Good afternoon. And thank you. Again, biodefense is a broad and diverse set of responsibilities. And the strategy takes into account the holistic nature of how we deal with the biodefense threat.

The Department of Homeland Security is ready to support the implementation of the National Biodefense Strategy, and is excited to do so.

We take into account the threat landscape has changed over the decade-plus that the Department has been involved in biodefense, and the preparedness posture and doctrine needs to change and evolve in response to those changes.

This is a larger than a whole -- even a whole-of-government -- larger than 15 agencies, larger than the whole of federal government that involves the whole of society. And the strategy recognizes that, and takes it into account.

SENIOR ADMINISTRATION OFFICIAL: So, if I could recognize [senior administration official] from DOD.

SENIOR ADMINISTRATION OFFICIAL: Thank you. So, it may be obvious the Department of Defense has an interest in intentional attacks that might occur, that type of bio incident. But we also have a keen interest in making sure that any naturally occurring outbreak is dealt with, because that could affect our force readiness.

So again, as was noted, the 1918 flu epidemic -- a case in point of how that really affected force readiness at that time. So that's a good case study.

There's -- so there's many things in this that the Department of Defense is very much involved with. Obviously, working with HHS on the -- just looking at medical countermeasures, in particular.

Our mission is to make sure our forces can maintain their mission. So it's not just enough to survive, they need to accomplish their mission, and basically we say we need to prepare to fight.

That's very similar to what our first responders need to do, if you look at the DHS mission and many of the people that they support. So there's commonalities and places where this Venn diagram crosses in many places. So the good thing about this new strategy is it codifies what has been, in many cases, ad hoc or a personality-led interaction. I think this will lead to more robust interactions and the coordination across all lines.

Lastly, I just want to say, I think it's particularly important right now: We talk about innovation and needing to foster innovation. There's also recognition that innovation can be used against us. So we're mindful of emerging threats that could be facilitated by innovation and, again, working together will be key to that, to success against that. Thank you.

SENIOR ADMINISTRATION OFFICIAL: And [senior administration official] from USDA.

SENIOR ADMINISTRATION OFFICIAL: Good afternoon. Just to echo the remarks of my colleagues, we all know the world today faces many new global health security risks due to the emergence/reemergence of (inaudible). And these include the (inaudible) which currently encompass 70 percent of all emerging diseases.

The health of our nation's people, animals, and plants are all interconnected, and a disease threat to one of these components can quickly affect another.

It is estimated that at least 75 percent of all infectious diseases that have a threat to our human health actually have an animal origin. And each of these threats are only increased by factors such as global trade and travel, the arise of drug resistance, or the potential for trans-boundaries threat.

As my colleagues all stated here today, preparing for these bio-threats is critical to our national security and requires such an effort as that -- an approach set forth by the National Biodefense Strategy that brings together a diverse spectrum of our stakeholders and partners, an expertise that focus on human health threats and animal health threats.

From an agricultural perspective, our food systems are just as vulnerable to disease and pests and poisonous agents that can naturally occur or be introduced in our food supply.

And according to 2016 data, ag and related industries contribute over $1 trillion to our nation's gross domestic product, making it one of the largest sectors of the U.S. economy.

Given this overall importance of food safety and protecting our nation's food supply here at home and around the world, protecting agriculture is also important in a bio threat and important to national security.

The National Biodefense Strategy emphasizes USDA's important role in safeguarding our nation's farmers and the agriculture system, and also keeps our department focused on accomplishing our main mission, which is (inaudible) and feeding everyone.

USDA, in line with this new strategy, has and will continue to be on the frontline with our agency partners in protecting our nation, and look forward to this collaborative effort and call to action.

SENIOR ADMINISTRATION OFFICIAL: So, I think we're ready for Q&A.

Q: Hi, my name is Jon Cohen. I'm with Science Magazine. Can you clarify what actually is changing? Who is the lead agency right now, operationally? And who is the lead agency policy right now? And I understand the change is going to HHS and NSC, but where is it right now?

SENIOR ADMINISTRATION OFFICIAL: So I'll -- this is [senior administration official]. So I think we -- you're recognizing that we have two previous strategies: We have a strategy from the Bush administration, and we have a strategy from the Obama administration.

I think the concern that was identified in the process of developing the National Biodefense Strategy was that there wasn't a clear accountability for who's in charge. We had, again, the congressional direction was to look across four departments and agencies. We actually identified 15 departments and agencies, plus the approximately 16 agencies of the intelligence community that all have a piece of biodefense.

And so, I think the President, consistent with his -- with his philosophy that you need to have clear lines of authority and accountability, felt like it was important to designate both a senior Cabinet-level official who would be responsible for coordinating the implementation of the strategy across the interagency, as well as providing accountability in the National Security Council for ensuring the prioritization of biodefense and to inform the annual budget commission process.

So, I'm not sure if that's as clear an answer as you're looking for. I think what's changed here is the clear lines of accountability and responsibility that President Trump felt was important when he signed the NSPM earlier today.

Q: Hi. This is Patsy Widakuswara with Voice of America. There has been significant criticism of the Trump administration's handling of global health security with its proposals to scale back funding for programs designed to keep the world safe from infectious diseases threat.

My question is: How prepared is the U.S. in dealing with the next global pandemic, considering you are cutting back international funding to assist countries to face this threat -- and also considering that the strength of the global preparedness is only as strong as its weakest link?

SENIOR ADMINISTRATION OFFICIAL: So I'm going to disagree with your premise. We're not cutting funding to deal with the global health security agenda. What you're probably referencing is a supplemental that was provided that covered the years FY15-19. We are just about to enter FY19 if the Congress provides the funding.

So the question will be, "What will be our posture in FY20?" And I'm not going to get ahead of the President in terms of -- as he writes the budget requests that he will submit to the Congress in February of next year, but it's incorrect to say we are cutting funding for global health security.

SENIOR ADMINISTRATION OFFICIAL: And I think, during the previous press conference that Ambassador Bolton and Secretary Azar participated in, they were very clear in their commitment to go forward in the future to support the global health security agenda. So I think it's -- as my colleague said -- that there is a -- yet to be seen what will be the budget for 2020. But there's -- there is a commitment to support this program.

Q: Hi. Thank you for taking my question. My name is Ike Swetlitz, I'm a journalist with STAT. And both in this conference and also earlier this morning, you mentioned specific new biotechnological innovations that might be concerning. I was wondering if you could talk a little bit more specifically if there are particular scientific techniques you're worried about with (inaudible) -- things like that, and how you're planning on dealing with them.

SENIOR ADMINISTRATION OFFICIAL: All right, so if I was going to raise that issue. That's raised frequently by a number of people, asking if we're dealing with this. I think maybe the best thing is to reference -- the National Academy of Sciences did a study for us. It was published in June of 2018. It lists really what are the biodefense concerns in the age of synthetic biology. So I'd refer you back to that.

And there were a lot -- many departments participated and developing a framework for that study. And so, I can speak for the Department of Defense: That's going to be our guide as we move forward.

Q: Hi, thanks for the doing the call. This is Tom Howell from the Washington Times. Can you just kind of talk about the process? You mentioned something about a 12-month process. What are you going to be looking for? What's kind of the chain of command of how you report your findings? And how are those incorporated going forward?

SENIOR ADMINISTRATION OFFICIAL: Sure. Certainly the role of the Department of Health and Human Services in all this is basically to convene with three other co-chairs: Department of Defense, Department of Homeland Security, and the Department of Agriculture. But all the other agencies that have represented biodefense-related capabilities, notably EPA -- you can go down the list of the other federal agencies that do, and basically walk through the strategy and evaluate what is the ongoing level of effort in programmatics that are being committed to those different parts of the strategy with the intent that, after the period of time, is to provide a comprehensive evaluation of what is being done by whom, with the level of effort that will be reported back to the national security advisor, and then will be part a formal policy process that my colleague can probably elaborate on.

SENIOR ADMINISTRATION OFFICIAL: So, each year has HHS leading the coordination of the implementation of the process together with USDA and DHS and DOD. We will -- the (inaudible) will take that government-wide biodefense assessment and develop an interagency joint policy guidance on the priority areas in biodefense that will be used by departments and agencies in the annual budget request process.

So again, you've not had before this level of attention at the level of the National Security Advisor, at the level of the Secretary of HHS, on behalf of the President, on biodefense. I think it's something that we feel very strongly -- I mean, given, again, the centenary of the great influenza pandemic, given the 17-year anniversary of the anthrax attack.

We have an Ebola outbreak in the DRC as we speak, and we had an outbreak earlier this year. We have been informed by all of this, in getting to the place here -- where earlier today the President signed both a strategy and the National Security Presidential Memorandum.

Q: Hi, this is Laurie Mylroie from Kurdistan 24. Isn't the problem regarding biological terrorism that there's really no good defense against it, and that you need to understand who the terrorists are -- have a very clear understanding of who is attacking you? Isn't the problem attribution? Is my question clear?

SENIOR ADMINISTRATION OFFICIAL: So, I'll ask some of my colleagues to join in to answer you, but I don't think I would agree with the premise that there's no good defense. I think the best defense is -- so early attribution is important to know what exactly is happening, but we -- I mean, it's a biodefense strategy. We have any number of capabilities. We have vaccinations, in fact, for Ebola. Today, we are in a different place than we were because we have vaccinations in place. We have screening procedures. I think Secretary Azar, earlier today, with Ambassador Bolton referenced that we are screening roughly 100,000 people per day in the DRC as part of containing Ebola.

So I think I would disagree with the premise that there is no defense, but I certainly would agree that attribution is important -- which is, again, is why I think the President decided to take the strategy he did, where we bring in the capabilities and the competencies of 15 different federal departments and agencies, as well as the intelligence community, to help us be better postured for attribution.

But my colleagues from DOD and DHS -- actually one of my colleagues from DHS is eager to answer your question.

SENIOR ADMINISTRATION OFFICIAL: Certainly. Attribution is extremely important in the case of a terrorist criminal act. But what we've seen with this strategy is we've taken -- opened the aperture much more broadly, that biodefense is not strictly limited to adversaries attempting to use bioweapons against us or anyone else; that this strategy encompasses both domestic and international. It takes into account intentional as well as naturally occurring biological events, as -- in a cohesive strategy moving from one to the other without silos. And that's part of the great strength of the strategy, I believe.

Q: Thank you. This is Donna Young from S&P Global News. I had a question. They have reiterated over and over in this call, as well as the earlier call, that this was a priority. This was something that was passed under a mandate in December 2016, so why did it take this long -- like more than a year and a half -- to actually implement if this was something that was such a priority?

And then also, on the innovation side: How is this going to actually do something more for, like, the small biotechs that are actually the ones who are developing the countermeasures? Thank you.

SENIOR ADMINISTRATION OFFICIAL: So, let me take the first part. And then maybe my colleague will take the second part.

I think you're exactly right: The requirement for a National Biodefense Strategy was quoted as part of the Fiscal Year of 2017 NDAA. All I can tell you is that, in trying to answer the mail, so to speak, looking at what Congress asked us to look at, we came to the conclusion that we actually wanted to go broader and bigger than the Congress had included.

The Congress asked to provide a strategy from four named departments: the DOD, AG, HHS, and DHS. And the administration came to the conclusion that biodefense is important enough, it's a high enough priority that we want a whole of government strategy, including 15 departments and agencies and the constituent elements of the intelligence community.

So that was -- part one was the actual strategy, but then we went a step further and the President issued a Nation Security Presidential Memorandum, which provides direction for the executive branch, for the interagency, for how the President wants biodefense run.

So I think both in terms of the fact that we went bigger than Congress contemplated and the President personally directed a reorganization of our efforts in a permanent process for an enduring level of attention on biodefense -- yeah, we might have missed the timeline that Congress articulated, but I think we actually did a deeper dive and set up an enduring process beyond what the Congress contemplated.

So a little bit late, but I think the product is vastly improved. And so my colleague is best person to talk to about the innovation question.

SENIOR ADMINISTRATION OFFICIAL: Thank you. And thank you for the question about innovation. I think one of the things to realize, as you read this strategy, you'll find that it makes reference to the National Security Strategy for one pillar, which is devoted to the protection of the American people and our way of life. And the second pillar is actually promoting American prosperity.

And so it is not limited to HHS. The role of innovation, as it relates to the life sciences is -- you'll find out that there are different departments and agencies that have BARDA-like activities besides Defense. HHS is one of them. And within the 21st Century Cures Act that was passed by Congress last year, there is a provision for Medical Countermeasure Innovation Partnerships, which is part of our BARDA DRIVe program -- the directorate for research, innovation, and ventures -- which is actually setting up accelerators regionally around the country to work with small biotechnology companies, as well as academic institutions, and, quite frankly, individuals -- because the democratization of the life sciences is actually allowing people to do do-it-yourself kind of biology.

And so, there's tremendous opportunities to find not only new cures for diseases, but potentially new ways to address some of the challenges around healthcare. And with that, innovation is a real opportunity to do that.

And so that's what kind of a unique part of this strategy. It looks comprehensively really against not only the challenges, but the opportunities that are afforded by the advances in biotechnology and the life sciences.

Q: Hi. This is Donna again, from S&P. So, in that last response from your colleague, I didn't actually hear, like, substantially, what are you going to do for the small biotechs? Is there going to be a broader commitment there to actually buy their products? What are you actually going to be doing on that end? Because I heard a lot of words, but I didn't hear a lot of, like, substance, as far as --

SENIOR ADMINISTRATION OFFICIAL: Oh, sure. Let me get granular with you. I can do that, so hang on. So specifically, it would be working to invest in biotech companies like venture capital companies would do. Number one -- and we've identified a number of particular areas where we think there's great opportunity to really change the status of healthcare, as well as improve biodefense.

One of the areas is around sepsis, which basically kills, oh, approximately 125,000 Americans a year, afflicts about 1.2 million people, and costs about $24 billion in healthcare costs a year. There's not a very good way to early diagnose it or to necessarily mitigate or treat its effects once it starts. And it is a complex of syndromes as it relates to both infectious diseases, radiation exposure, as well as chemical exposures. So it is, as we (inaudible) to death for many folks. And (inaudible) find some better treatments, we think we can actually make an improvement for all Americans in that vein.

So, for example, if we can find a way to mitigate not only the loss of life, but the cost, we believe we can save the U.S. government about $16 billion a year in Medicare or Medicaid costs that are associated with sepsis alone.

Another area that's a focal area is early diagnosis of people who may not yet show symptoms of a disease, but may be infected and are incubating that disease, or the opportunity to intervene and potentially provide lifesaving or mitigating the morbidity (inaudible) can be done.

So those just are a couple examples. There are a lot more, but it's really working with different states and different institutions around the country. I know that in Washington state, we're working with the Life Science Institute. We're working around the country trying to basically break down the walls and barriers to work with small companies and individuals who are working in the life science biotech area.

SENIOR ADMINISTRATION OFFICIAL: And if I could add to that -- so one of the barriers for people, especially the smaller companies, to work with the government -- and I can speak specifically for the Department of Defense -- it's very difficult. Our process is the government -- you know, Federal Acquisition Regulations -- don't make it easy. And so we've gone out and talked to some of these small companies that we rely on, and that's some of their biggest concerns they have.

So in addition to facilitating different funding mechanisms and technology (inaudible), we're also looking at our business processes to make sure we can still have the correct level of oversight that the public asked of us -- but at the same time, trying to be innovative in an expedient way so that the innovations are actually timely.

Q: Hi, this is Sarah (Inaudible) from Politico. In the earlier press conference, Secretary Bolton had said that the memorandum today repealed prior authorities. What exactly was he referring to there?

SENIOR ADMINISTRATION OFFICIAL: So, Ambassador Bolton was referring to a Bush administration presidential policy document, and an Obama administration presidential policy document. So those are replaced in the as-yet-unnumbered National Security Presidential Memorandum that the President signed a short time ago.

Q: Hi, this is Heather (inaudible) from the Frederick News Post. I was just wondering how this plan is going to affect the labs at Fort Detrick, whether that's going to affect the National Biodefense Analysis and Countermeasures Center that was almost shut down in 2017 as well.

SENIOR ADMINISTRATION OFFICIAL: So I'm sorry, could you repeat your question? We're going to turn up the volume a little bit, but we want to make sure we got it exactly right.

Q: Did you hear that?

SENIOR ADMINISTRATION OFFICIAL: No. Can you please repeat your question?

Q: Sure. I was just wondering how the labs at Fort Detrick are going to be affected by the new strategy.

SENIOR ADMINISTRATION OFFICIAL: The new strategy does not directly discuss any particular asset of any one agency or department. But I think it reflects -- what we've been talking about along is that those assets that you referred to are national assets, and that they need to be made available and useful across the whole of government for the purposes of biodefense activity.

Q: Hi, it's Ike Swetlitz again from STAT. I was just hoping you could elaborate a little bit more on some of the changes that you're going to be making to the business processes for working with biotech companies that you mentioned.

SENIOR ADMINISTRATION OFFICIAL: There's some specifics of -- you know, the Federal Acquisition Rules -- and especially for Department of Defense, the process is very onerous. Everything is treated like a huge defense system.

Under Secretary Lord, who was in charge of acquisition and sustainment -- you know, she's making a real push right now to make sure we can use some other novel contracting mechanisms. There's something called "other transaction authorities." You could google that and learn more about that, what it specifically means.

And basically what it comes down to is not treating everything the Department of Defense does like an aircraft carrier. And that's according to her -- that phrase. But it's just trying to be more nimble and responsive.

We -- again, we've talked to a lot of small innovators, you know, biopharma across the board. And just the accounting requirements that the government puts on small businesses is too onerous, certainly, to incentivize them to work with us.

We sponsored consortia -- various consortia to try to get at this. I was at a meeting last week of an engineering biology research consortium, for example. And there we were engaged with academics, small companies -- and a lot of these are spin-offs from academia -- trying to ascertain what could really meet their needs so they could in turn work with us. So there's a lot of different facets to this. But a lot of this is involving community engagement.

If I can also refer back to the question about why this took so long: This was a whole of government effort, but it was actually a whole of society effort. As this was being developed, there was some town hall meetings that brought in people from the private sector to give their views. It was a panel discussion, a lot of dialogue back and forth where concerns were aired along these lines. And those discussions led to some of the input into the strategy itself.

Again, that goes towards engaging with that private sector to make sure we're listening to them and then trying to be as responsive as possible.

Q: Hi, this is Jon Cohen again with Science. Does this downgrade Homeland Security's role in coordinating from the Security Act of 2002, where Homeland Security had specific priorities that you seem to be transferring now to HHS and NSC?

SENIOR ADMINISTRATION OFFICIAL: So I'm going to defer to DHS to let them tell you whether or not they think their role has been downgraded.

SENIOR ADMINISTRATION OFFICIAL: So the simple answer is no. I think that the language that is articulated in HHS as the lead for the implementation of this strategy is quite accurate. However, it doesn't say that, during a particular incident, the Department of Homeland Security would be abdicating its coordination role that it has consistent with articulated policy doctrine.

SENIOR ADMINISTRATION OFFICIAL: And I would just jump in on that and just say, we're talking about elevating the level of prioritization for biodefense and recognizing the threat posed by bio threats across the board, day to day.

There will of course be, you know, individual occurrences. I mentioned a couple times we have an Ebola situation today. A week and a half ago, we all were glued to the news -- or at least I was -- because an airplane, an Airbus 380 with about 500 people, landed at JFK. There are lead agencies for scenarios like that, just as there are lead agencies for scenarios like the Ebola situation in the DRC today.

What we are talking about with the President's National Security Presidential Memorandum is how we ensure that biodefense and the different approaches by 15 departments and agencies and the IC are unified, and the priority of the President attaches to biodefense is enduring.

Q: Thanks for doing this. I just have one question about the Cuba sonic attacks. How does this -- does this have any impact in that, or preventing similar type of scenarios from happening or combat them?

SENIOR ADMINISTRATION OFFICIAL: So, if I may, we're here to take about the biodefense strategy. We can -- you can reach out to our respective press operations. We can talk to you about other matters related to, for example, the health incidents you referenced. I would note there is ongoing investigations underway. And I'll just leave it at that for right now.

END 1:08 P.M. EDT

Donald J. Trump, Press Briefing by Senior Administration Officials on the National Biodefense Strategy Online by Gerhard Peters and John T. Woolley, The American Presidency Project

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