Alex Michael Azar II (born 1967)

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Alex Michael Azar II (/ˈəzɑːr/; born June 17, 1967) is an American attorney, former pharmaceutical lobbyist and executive, and current member of Donald Trump's cabinet who serves as the United States Secretary of Health and Human Services. Azar was nominated to his post by President Donald Trump on November 13, 2017, and confirmed by the United States Senate on January 24, 2018.

Azar served as General Counsel of the United States Department of Health and Human Services (HHS) from 2001 to 2005. On July 22, 2005, he was confirmed as the Deputy Secretary of Health and Human Services; he served in that capacity until his January 2007 resignation.

From 2012 to 2017, Azar was President of the U.S. division of Eli Lilly and Company, a major drug company, and a member of the board of directors of the Biotechnology Innovation Organization, a large pharmaceutical lobby.

Early life[edit]

Azar was born on June 17, 1967, in Johnstown, Pennsylvania, the son of Lynda (Zarisky) and Alex Michael Azar.[2][3] His father is of Maronite Lebanesedescent, while his maternal grandfather was a Jewish immigrant from the Russian Empire.[4][5] His father, also named Alex Azar, is a retired ophthalmologist who practiced ophthalmology in Salisbury, Maryland, for more than 30 years, and taught at Johns Hopkins Hospital. His grandfather emigrated from Lebanon in the early 20th century.[6]

Azar attended Parkside High School in Salisbury, Maryland, from 1981 to 1985. He received a B.A. degree summa cum laude in government and economics from Dartmouth College in 1988. He belonged to the Kappa Kappa Kappa fraternity. He earned a J.D. degree at the Yale Law School in 1991, where he served as a member of the executive committee of the Yale Law Journal.[7][8]

After law school, from 1991 to 1992, Azar served as a law clerk for controversial Judge Alex Kozinski of the United States Court of Appeals for the Ninth Circuit. Azar left after six weeks, and was replaced in Kozinski's chambers by Brett Kavanaugh.[9] Azar subsequently clerked for the remainder of the term for Judge J. Michael Luttig of the United States Court of Appeals for the Fourth Circuit. From 1992 to 1993, he served as a law clerk for Associate Justice Antonin Scalia of the United States Supreme Court.[10]

From 1994 to 1996, he served as an Associate Independent Counsel for Ken Starr in the United States Office of the Independent Counsel, where he worked on the first two years of the investigation into the Whitewater controversy.[11][12] At the time of Azar's appointment, he was working as an associate in Starr's law firm.[11]

Between 1996 and 2001, Azar worked for Wiley Rein, a Washington, D.C., law firm, where he achieved partner status.[13]

Health and Human Services[edit]

Official Deputy Secretary portrait

On August 3, 2001, Azar was confirmed as General Counsel of the United States Department of Health and Human Services.[14][15] George W. Bush's first HHS Secretary, Tommy Thompson, said Azar played an important role in responding to the 2001 anthrax attacks, ensuring there was a vaccine ready for smallpox, and dealing with outbreaks of SARS and influenza.[6] On July 22, 2005, Azar was confirmed as the Deputy Secretary of Health and Human Services.[16][17] He was twice confirmed unanimously by the United States Senate.

Working under Secretary Mike Leavitt, Deputy Azar supervised the operation of HHS, which would grow to annual budget of over $1 trillion by 2017 when he was appointed Secretary. Azar led the development and approval of HHS regulations, led U.S. government efforts to encourage worldwide pharmaceutical and medical device innovation, and was in charge of the HHS response to an initiative implemented by President George W. Bush to improve government performance.[6]

Azar resigned in January 2007.[18]

Eli Lilly & Co.[edit]

In June 2007, Azar was hired by Eli Lilly and Company chief executive officer Sidney Taurel to be the company's top lobbyist and spokesman as its Senior Vice President of Corporate Affairs and Communications.[6][19] Azar left the position after the 2008 United States presidential election was won by Democratic Party candidate Barack Obama and the corporation wanted to replace Azar with a Democrat in that role.[citation needed]

In April 2009, Azar became Vice President of Lilly's U.S. Managed Healthcare Services organization and its Puerto Rico affiliate.[20] In 2009, the company paid $1.415 billion to settle criminal charges regarding its promotion of antipsychotic drug Zyprexa (olanzapine) for off-label uses between 1999 and 2005.[19]

Effective January 1, 2012, Azar became President of Lilly USA, LLC, the largest division of Eli Lilly and Company, and was responsible for the company's entire operations in the United States.[20]Prices for drugs rose substantially under Azar's leadership, including the tripling of the cost of the company's top-selling insulin drug. Also under Azar's watch, Eli Lilly was one of three companies accused in a class-action lawsuit of exploiting the drug pricing system to increase profits for insulin. Eli Lilly was also fined in Mexico for colluding on the price of insulin.[21][22] In connection with the position, Azar served on the board of directors of the Biotechnology Innovation Organization, a pharmaceutical lobby.[23]

In January 2017, Azar resigned from Eli Lilly "to pursue other career opportunities" as a result of a company reorganization.[24] He also resigned from the board of directors of the Biotechnology Innovation Organization. In his last year at the corporation he earned $2 million.[25]

Secretary of Health and Human Services[edit]

Nomination and tenure[edit]

Azar and his family (with President Trump and Vice President Pence) shortly after being sworn in as Secretary of Health and Human Services

On November 13, 2017, President Trump announced via Twitter that he would nominate Azar to be the next Secretary of Health and Human Services.[23][26]

Many health care advocates raised concerns about the nomination, citing Azar's track record of raising drug prices and his opposition to Obamacare; his preferences, that is, for a "free market" to meet all Americans' health care needs.[27] Critics noted that Azar approved a tripling of the price of insulin while CEO of Eli Lilly.[28][29] Speaking in favor of his nomination were two former U.S. Senate Majority Leaders, Democrat Tom Daschle and Republican Bill Frist. Both those endorsers were affiliated with the Bipartisan Policy Center, a Washington D.C. think-tank which receives support from Eli Lilly.[30]

In spite of objections, his nomination was relatively smooth. Azar was confirmed on January 24, 2018, with a vote of 55–43,[31] with most Democrats opposed. Voting against him, Oregon Senator Ron Wyden, ranking member on the Senate Finance Committee, said that while Azar was at Eli Lilly, he "never, not one time, signed off on a decrease in the price of a drug.[32] Senator Bernie Sanders said in a press release, "The nomination of Alex Azar, the former head of Eli Lilly's U.S. operations, shows that Trump was never serious about his promise to stop the pharmaceutical industry from 'getting away with murder'." "The last thing we need is to put a pharmaceutical executive in charge of the Department of Health and Human Services." During that tenure, Eli was fined for colluding to maintain high drug costs in Mexico.[28]

Azar had additionally consulted with numerous other biopharmaceutical and health insurance corporations regarding government policy, product access, sales and marketing, pricing, reimbursement and distribution.[28] He was confirmed by the Senate on January 24, 2018 and sworn in by Vice President Pence on January 29, 2018.[33]

Healthcare policy[edit]

Affordable Care Act[edit]

Azar has been a critic of the Patient Protection and Affordable Care Act (Obamacare) and predicted in 2017, "There will be a piece of legislation passes this year that is called the repeal of Obamacare. I don't know what's going to be in the substance of it, but there will be a piece of legislation that says that."[26] Also regarding the ACA, Azar said the Department of Health and Human Services has latitude to "make it work a little better".[22]

Abortion[edit]

Azar opposes abortion. In a written response to Senator Patty Murray regarding future HHS policy, he said, "The mission of HHS is to enhance the health and well-being of all Americans, and this includes the unborn."[34]

Regulations[edit]

According to The New York Times, Azar differed with his predecessor, Tom Price, in terms of their approach to regulations. Writing in May 2018, The Times said, "in a sharp break from his predecessor — and from most Trump cabinet secretaries — he seems to be relishing the chance to write new regulations, rather than just crossing out Obama-era ones."[35]

Coronavirus[edit]

Outbreak[edit]

Azar speaks to the White Housepress corps on COVID-19 in March 2020

President Trump, with Azar, signs the Coronavirus Preparedness and Response Supplemental Appropriations Act into law on 6 March 2020

Azar informed associates that he had alerted Trump on January 18, 2020, regarding the potential danger from COVID-19, but that the president thought he was being "alarmist" as Azar struggled to get Trump's attention to focus on the issue.[36] Despite Azar's warnings, four days later, Trump announced, "We have it totally under control. It’s one person coming in from China."[36] On January 28, 2020, Azar stated that the Trump administration had no plan to declare a public health emergency as the COVID-19 virus spread in China. He asserted that the risk to Americans was minimal, but admitted that authorities in 30 states were monitoring potential cases and added that he would not "hesitate at all to invoke any authorities I need to, to ensure we’re taking all steps to protect the American people, but I’ll do it when it’s appropriate." U.S. Senator Rick Scott and U.S. Representative Vern Buchanan, as well as other Republicans, demanded the declaration of a public health emergency as a means of budgeting necessary federal funding to deal with the potential pandemic. At the time, Azar said, there were just five confirmed cases in the U.S., there was no known person-to-person transmission, and every confirmed U.S. victim had traveled to Wuhan, China (the outbreak's place of origin). "This is potentially a very serious public health threat, but at this time Americans should not worry about their own safety," Azar said. At that point, the disease had killed at least 106 people in China, with more than 4,500 cases confirmed.[37]

On February 27, U.S. Representative Jimmy Gomez of California revealed that he had been contacted by a whistleblower from the Department of Health and Human Services (HHS) who had been dispatched to deal with the arrivals of travelers exposed to the coronavirus. There were allegations made that those sent from the HHS to California quarantine sites lacked both sufficient protective clothing and the training necessary to prepare them to deal with the contagion, though they were working alongside CDC personnel who had adequate protective gear.[38] The whistleblower also said that professionals raising concerns about the unsafe practices were subjected to retaliation.[38] Azar responded to the issues raised by Gomez by saying, "Urgency does not compensate for violating isolation and quarantine protocols" and adding, "I'd want to know the full facts and would take appropriate remedial measures."[38][39]Azar insisted that careful protocols were being observed by all CDC employees.[38]

On February 28, 2020, United States Senate Finance Committee ranking member Ron Wyden wrote Azar to ask why HHS Administration for Children and Families employees were involuntarily dispatched to California to meet with quarantined travelers despite lacking expertise in the field and lacking proper information, equipment and training. Wyden also asked why said employees were not cleared to ensure that they had not become carriers of the disease before they were returned to their home stations.[40]

Centers for Disease Control and Prevention[edit]

As Secretary of Health and Human Services, Azar is responsible for the Centers for Disease Control and Prevention (CDC), a key institution in charge of containing contagious diseases. On January 28, 2020, Azar requested that the Chinese government allow a CDC expert team into their country to help them learn more about the virus. Referring to the SARS epidemic 17 years earlier, Azar said, "I can say that the posture of the Chinese government levels of cooperation and interaction with us is completely different from what we experienced in 2003 and I want to commend them for such assistance". The World Health Organization had already agreed to supply international experts to visit China "as soon as possible." Seventy-three possible cases were being monitored in the U.S. Simultaneously, the CDC had ramped up coronavirus screenings of travelers coming into the U.S. at 20 airports. Azar said it might be possible to ban any travelers arriving from China, and all options had to be considered. "Diseases are not terribly good at respecting borders," he added.[41]

Congressional testimony and requests for funding[edit]

On February 25, 2020, Azar appeared before the Senate Appropriations Committee to testify on the danger of and responses to the 2019–20 coronavirus pandemic. Louisiana Republican Senator John Kennedy asked both Azar and Chad Wolf about the fatality rate in victims. Azar said that the fatality rate of seasonal influenza was about 0.1%, and that the fatality rate of COVID-19 was estimated at between 1% and 2%; however, Azar added that the latter figure was uncertain because there might be many mild coronavirus cases yet unreported.[42] Chad Wolf said that the fatality rate for COVID-19 was between 1.5% and 2%, and that the fatality rate for influenza over the last 10 years in America was similar (about 2%).[43][44] Kennedy was unhappy with the briefing, saying afterwards, "I thought a lot of the briefing was bullshit... They would answer the question but dodge, bob and weave. I understand there’s a lot they don’t know. I get that. But they need to answer the questions straight up. They all talk about a task force, a committee — a committee's not going to solve this problem".[45]

Trump's officials tried to allay concerns that their request for $2.5 billion was insufficient to address the epidemic. Some Republicans joined Democrats in criticizing the funds requested and found transparency lacking with regard to a coherent strategy to contain the virus. Another Republican, Senate Appropriations Committee Chairman Richard Shelby of Alabama, told Azar: "If you lowball something like this, you'll pay for it later."[46][47][48] Pennsylvania Democratic Congressman Brendan Boyle asked Azar how he could defend "draconian cuts" in the CDC budget “at the same time we are facing a unique worldwide health crisis".[48] Two years earlier, a coalition of global health organizations opposed Trump's plans to reduce the CDC's operations in 39 of 49 countries in which it had been helping to rapidly identify and suppress outbreaks of diseases. The coalition wrote to Azar, contending, "These programs are essential to our national defense".[48] [49] In 2018, National Security Adviser John Bolton dismantled the task force charged with responsibility for planning and response to epidemics. The team's leader, Rear Admiral Timothy Ziemer, was the leader of the anti-malarial efforts under presidents Barack Obama and George W. Bush.[48] White House Homeland Security adviser Tom Bossert, who had advocated a comprehensive biodefense strategy against both pandemics and potential biological attacks, departed from the White House on the same day Bolton arrived.[48]

Testing[edit]

Further information: COVID-19 testing

On March 2, 2020, Azar was criticized for unpreparedness that may have accelerated the spread of the virus. Some critics focused on the lack of definitive testing of those who might be spreading the virus. China had tested over 1,000,000 people, while the CDC had tested less than 500 and its results had been undermined by problems with accuracy and potential contamination. There was substantial internal feuding with regard to formulation of policy at HHS and the CDC.[50]

Vaccine[edit]

Azar argued that the pharmaceutical industry was best poised to discover, manufacture, and market a vaccine for coronavirus. When asked about the cost of vaccines, Azar responded that the price might be high, but that an important vaccine would be created even if many Americans could not afford it.[51]

Personal life[edit]

Azar is an Eastern Orthodox Christian. He is of Lebanese, Ukrainian, English and Swiss descent and lives in Indianapolis with his wife and two children.[33][52] Azar served for two years on the board of HMS Holdings.[53] He is currently on the board of the American Council on Germany, where he is Chairman of the Strategic Planning Committee, and the Indianapolis Symphony Orchestra.[13]

He has previously served on the board of directors of the Healthcare Leadership Council, where he was Treasurer; the National Association of Manufacturers; and the Indianapolis International Airport Authority, where he was Chairman of the Human Resources Committee.[13]

Azar is a Republican and has contributed to the campaigns of Mike Pence, Mitch McConnell, Orrin Hatch, Lamar Alexander, Jeb Bush, and Donald Trump according to the Center for Responsive Politics.[6]

https://www.hhs.gov/about/news/2019/09/14/secretary-azar-meets-local-leaders-visits-ebola-treatment-center.html

2019-09-14-hhs-gov-secretary-azar-meets-w-local-leaders-visits-ebola-treatment-center.pdf

FOR IMMEDIATE RELEASE

September 14, 2019

Secretary Azar Meets with Local Leaders and Visits Ebola Treatment Center

“The U.S.A. is here for you not just for Ebola, but also healthcare after Ebola.”—HHS Secretary Alex Azar

BUTEMBO, DRC—Today, September 14, Health and Human Services Secretary Alex Azar, Dr. Robert Redfield, Director of the Centers for Disease Control and Prevention (CDC); Dr. Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID); Garrett Grigsby, Director of the HHS Office of Global Affairs; Tim Ziemer, Senior Deputy Assistant Administrator of the United States Agency for International Development (USAID); Mike Hammer, U.S. Ambassador to the Democratic Republic of the Congo (DRC); and staff of President Trump’s National Security Council joined World Health Organization (WHO) Director General Tedros Adhanom Gebreyeus and United Nations (UN) Emergency Ebola Response Coordinator (EERC) David Gressly in Butembo, DRC, where they toured an Ebola treatment center near the center of the outbreak.

During the visit, the delegation observed the detection, infection prevention, and control measures. They spoke to the healthcare providers about how they provide care for patients at the Ebola treatment center and saw patients being successfully discharged from the center. The delegation also heard from officials and healthcare workers about the challenges they face in providing care due to mistrust and the conflict in the region. Secretary Azar shared his sincere gratitude for the hard work and dedication all personnel have shown in the face of this health crisis.

Secretary Azar and the delegation also participated in a discussion with local community leaders and health personnel. The delegation heard firsthand from the women’s association leader, the Federation of Commerce, the leader of the cultural associations, the representative of traditional leaders, and an Ebola survivor. They shared their perspectives on how to engage the communities more effectively in the response to combat misinformation and improve outcomes.

Secretary Azar expressed the U.S. government’s strong commitment to ending the Ebola outbreak and commitment to work with local, community leaders along the way. “The U.S.A. is here for you not just for Ebola, but also healthcare after Ebola,” he told the community meeting. The U.S. recognizes that health challenges in the DRC extend past Ebola and also supports efforts to fight measles, malaria, HIV, tuberculosis, cholera, and other diseases.


https://nihrecord.nih.gov/2019/07/26/hhs-secretary-department-leaders-attend-hiv-meeting-nih

2019-07-26-nihrecord-nih-gov-hhs-secretary-department-leaders-attend-hiv-meeting-nih.pdf

Health and Human Services Secretary Alex Azar visited NIH for the HHS Global-Domestic HIV Meeting: Successes and Challenges Reaching the 95-95-95 Goals. Held June 26 in Bldg. 45's Kirschstein Auditorium, the day-long meeting gathered department leaders to share ideas about common challenges in the HIV response; exchange lessons learned in HIV policy, program, implementation and research across the global and domestic experiences; and create recommendations for further collaboration across HHS. NIH director Dr. Francis Collins opened the meeting with welcoming remarks. Azar discussed the President’s initiative, Ending the HIV Epidemic: A Plan for America.

Later, a panel featuring representatives from HHS agencies offered an opportunity for each to highlight contributions and areas of expertise in ending the HIV epidemic, both domestically and globally.


2019-07-26-nihrecord-nih-gov-hhs-secretary-department-leaders-attend-hiv-meeting-nih-img1.jpg

HHS Secretary Alex Azar (r) is greeted by (from l) NIAID director Dr. Anthrony Fauci, FDA acting commissioner Ned Sharpless, NIH Director Dr. Francis Collins, and CDC director Dr. Robert Redfield.

2019-07-26-nihrecord-nih-gov-hhs-secretary-department-leaders-attend-hiv-meeting-nih-img2.jpg

Azar discusses the President's initiative, Ending the HIV Epidemic: A plan for America.

2019-07-26-nihrecord-nih-gov-hhs-secretary-department-leaders-attend-hiv-meeting-nih-img3.jpg

Shown seated at the panel are (from l) Redfield, Sharpless, Dr. George Sigounas of HRSA, Radm. Michael Toedt of IHS, Fauci, and Dr. Elinore McCance-Katz of SAMHSA.


https://www.whitehouse.gov/briefings-statements/press-briefing-national-biodefense-strategy-091818/

2018-09-18-whitehouse-gov-briefings-national-biodefense-strategy

Press Briefing on the National Biodefense Strategy

Issued on: September 18, 2018

James S. Brady Press Briefing Room

11:30 A.M. EDT

MR. MARQUIS: I’m Garrett Marquis at the NSC. We’re here for a briefing that’s off camera, but on record, on the National Biodefense Strategy.

We have Ambassador John Bolton, National Security Advisor, and Health and Human Services Secretary Azar, as well. How this will flow is the Ambassador will make a few remarks, followed by Secretary Azar, and then brief Q&A, which I’ll manage.

We have about 25 minutes, maybe a little bit less. And the focus of this, of course, is on the National Biodefense Strategy, so please make sure your questions are relative to that.

With that, Ambassador Bolton.

Q (Inaudible) embargo?

MR. MARQUIS: It’s embargoed until we inform you (inaudible). Embargoed until 12 o’clock.

AMBASSADOR BOLTON: Well, thanks, Garrett. Thanks to all of you for being here. Last week, we commemorated the 17th anniversary of the 9/11 attacks. Today is actually the 17th anniversary of the anthrax letters, which were distributed and were thought to be an indication of possible further terrorist activity, really, I think, bringing to the attention to the American people, many of them for the very first time, the threat of bioweapons in the hands of terrorists or adversary nations.

What we’re going to do today is release the National Biodefense Strategy, which we’ve worked out through the National Security Council process. And the President will also sign a National Security Presidential Memorandum, which will repeal prior authorities and put a new process in place.

This is, we think, critical for our defense purposes, looking at the range of weapons of mass destruction that the United States and our friends and allies face. We all focus on nuclear weapons, but biological weapons and chemical weapons are very, very dangerous. Bio and chem are often referred to as the poor man’s nuclear weapon, so they’re particularly attractive to terrorist groups that want to try and cause great damage to us here at home.

So what we’ve done is establish a Cabinet-level biodefense steering committee that will be chaired by the Department of Health and Human Services. This is the approach that we think is going to be best suited for carrying out the strategy operationally. And Secretary Azar, who will speak to you in a second, will be chairing that.

The division of labor here is that the role of the NSC is the coordination of the development and implementation of the policy, but operationally carrying out the policy will be through this committee that HHS will chair. NSC, in this area or any other area, is not operational, going back to the lessons of the Tower Commission report after the Iran-Contra affair.

But the operational effort is something we expect to be on an ongoing basis for HHS to be the lead on. Other Cabinet departments that are involved: obviously the Defense Department; the Agricultural Department, because a biological weapons attack could be directed against our food supply, against plant and animal life. Homeland Security has a role, EPA and others.

Now, this is a biodefense strategy. It’s not what our offensive counter-response would be if we were attacked. That’s something we do through the regular national security channels. But it’s really what we would do here in the United States and with our friends and allies.

And our intention, having now written this strategy which the President will sign, is to review it on an annual basis to move away from the concept we see in too many strategy documents, that they’re written and then that’s the end of the process. We want it to be continuing. HHS plays the lead role, as I say, in implementing, operationalizing this. And so we’re going to work very closely together on this critical need to protect the American people from the threat of biological warfare.

So now let me turn it over to the Secretary of HHS, Alex Azar.

SECRETARY AZAR: Well, good morning, everybody. And thanks for joining us here today. I wanted to complement what Ambassador Bolton just had to say by laying out a couple of points.

I wanted to give you the historical context for the strategy and why HHS is taking the lead on biodefense, and how it also reflects the lessons that we’ve learned about the serious threats that we face.

So, first of all, why a biodefense strategy? The simple answer is that biological threats of a manmade, accidental, or naturally occurring nature are very real and they’re growing. There are several factors that drive their growth:

As the world grows more urbanized and interconnected, infectious threats can spread more rapidly and easily than ever. Think about one of the threats that HHS is monitoring at this very second, which is the Ebola outbreak in the Eastern Democratic Republic of the Congo. Such is the ease of mobility between countries now, that just in the DRC, more than 100,000 people are being screened at border crossings every day.

We also face accidental and manmade threats. Today’s rapid technological advances have great potential to improve public health and human health, but they also create the opportunity for new kinds of threats and for more and more actors to make use of biological weapons. These trends are not new, so the release of this national strategy is an important culmination of a long series of steps taken by HHS and the entire U.S. government over decades to build our biodefense capabilities.

As you’ll notice — and once you see the materials — at each stage, the growing complexity of these threats demanded the involvement of more and more of the top-flight biomedical and public health expertise that we have at HHS. Back in the ’90s, the Secretary, Donna Shalala, declared HHS a national security agency, detailing a Public Health Service Commissioned Corps officer to the National Security Council for the very first time.

The recognition of the importance of HHS’s public health expertise to national defense grew during my first tenure in the department back in the 2000s. In the days following September 11, 17 years ago to the day, HHS was tasked with evaluating our preparedness for biological threats. And that became a very tangible responsibility with the anthrax attack 17 years ago today.

I was personally involved in much of managing the response, and we saw the importance of coordinating across government agencies. It was the FBI that had the actual spore sample, since it was criminal evidence, but we needed CDC’s scientific expertise to discover that we were actually dealing with a new form of anthrax with spores so small that they were seeping through envelopes that had not even been open by the recipients.

Throughout my time at HHS, we’ve faced a number of other biological threats: SARS, monkeypox, pandemic flu, MERS, and more. In response, we’ve had to significantly expand the Department’s preparedness and response capabilities, including the creation of the Office of the Assistant Secretary for Preparedness and Response.

We transformed what had been a national stockpile of pharmaceuticals into a strategic national stockpile that contains countermeasures for a wide variety of threats. We oversaw the creation of the National Disaster Medical System, which has thousands of civilian health professionals on call to prepare for and respond to healthcare and public health needs caused by disaster. In fact, right now, hundreds of NDMS members are working to respond to Florence, but they’re equally important in the event of a pandemic or a biological attack.

We also created BARDA, the Biomedical Advanced Research and Development Authority, which supports the private sector to develop medical countermeasures, like vaccines, diagnostic tools, and antibiotics that will help us respond to biological, chemical, nuclear, and radiological threats.

BARDA in particular was a response to a need identified about lack of coordination. There was no single entity in the government, before BARDA, or anywhere else that was interested in bringing countermeasures from basic scientific research, all the way through development, to stockpiling and deploying those assets until we created BARDA.

So that speaks to one particular need for the biodefense strategy, and one of its key elements — that’s the need they coordinate across different government agencies and the private sector.

The threats that HHS dealt with under President Obama provided another lesson about the need for a coherent and coordinated strategy. The 2014 Ebola crisis demanded efforts from all across the government. HHS took the lead on treatment and epidemiological work in West Africa and here in the U.S. But there were significant roles played by the State Department and USAID, as well as for Department of Homeland Security components, like Customs and Border Patrol. It was widely recognized that, early on, the response was not nearly as well coordinated as it should have been.

So those are a couple of other lessons incorporated into this biodefense strategy. For the first time, invest accountability in one place — the Secretary of HHS — as chairman of a coordinating committee. And it covers naturally occurring threats for the first time ever.

This is a cooperative effort with expertise from many domains, but it’s a cardinal rule of leadership that you have to have accountability, which means one leader, and that’s a leadership lesson well understood by the President.

Many of the HHS activities I’ve just discussed will fall under this new biodefense strategy. By incorporating them into this broader framework with other agencies, we’re going to have a much easier time identifying where we have gaps in our capabilities and preparedness, and addressing them in the most efficient way possible.

Most fundamentally, this strategy represents the importance to the President and to the country of biodefense as a fundamental and distinct aspect of our national security. Before 9/11, a future President understood this and recommended that we do a much better job of preparing for the possibility of a biological attack. “Our adversaries understand that if they are able to blindside us,” he wrote, “they will be much more likely to succeed in blackmailing us.” That future President was Donald Trump and the year was 2000.

With this strategy and President Trump’s commitment to defending the health and wellbeing of the American people, it’s going to be much harder for any threat — for our adversaries to be able to blindside us.

So thank you very much. And happy now with Ambassador Bolton to take questions.

MR. MARQUIS: Thank you. And just to be clear, the embargo is actually 1:00 p.m. And at that time, you’ll also see a statement from the President and a factsheet come out from the White House Press.

Steve.

Q Ambassador Bolton, how vulnerable is the United States to a bio-attack? And who do you — are you suspicious of wanting to attack us?

AMBASSADOR BOLTON: Well, Secretary Azar may want to address this as well. But we’re constantly monitoring a range of countries and terrorist groups for the possibility that they would acquire a biological weapons capability that could threaten us.

And the attack can come in a lot of different ways, either directly in the homeland;. It could come from people traveling into the United States previously infected. It could come from stockpiles that are smuggled into the United States or may already be here. This is something we speak with our allies about all the time.

There are any number of countries that are not the parties to the Biological Weapons Convention. There are parties that are — states that are parties to the Biological Weapons Convention that we think are violating it. I don’t want to get into the intelligence at this point, but we take very seriously, as we do across the range of weapons of mass destruction, the dangers to the United States from this kind of attack, which is why we felt that bringing all of this together in a coordinated government-wide biodefense strategy to create an accountable, operational capability was so important.

SECRETARY AZAR: Yeah. I would just add the importance of non-state actors and even individuals. Remember, the anthrax attacks were conducted by an individual. So you have terrorist groups, non-state actors. Unfortunately, with the democratization of biotechnology expertise, it’s a dangerous world out there, and many would either seek to do intentional harm or could even inflict accidental harm through lack of appropriate bio-security in labs.

MR. MARQUIS: Francesca.

Q Thank you. I wanted to take advantage of your time a little bit here, Ambassador Bolton, since you are here, and I wanted to ask you about Kim Jong Un’s comments today about the United States. He said that, thanks to President Trump, the political situation in the region has been stabilized because he is with Moon Jae-in in South Korea today.

But at the same time, an editorial today in North Korea said that due to United States’ nonsensical, irrational stubbornness, there are issues that can’t be discussed right now, specifically referring to denuclearization. So I wanted to ask you for your response to that. And if you could tell us a little bit more about whether or not there will be another summit between President Trump and Mr. Kim anytime soon.

AMBASSADOR BOLTON: Yeah, I’d love to discuss the subject, but we are here today, really, just to discuss the biodefense strategy. So another time.

Q So you have no comment? You have absolutely no comment on that?

MR. MARQUIS: Is this a biodefense question?

AMBASSADOR BOLTON: We’re confining this to the subject matter of the briefing.

MR. MARQUIS: Please.

Q Ambassador Bolton and Secretary Azar, can you talk a little bit about any potential cost to what you’re talking about? Is there a price tag? Are you asking for any more money from Congress? And is there any new legislation that you feel needs to follow these actions, or is this simply a reorganization within the government?

And one more question. Just to follow up — when you talk about the potential of people that would be carrying out these types of attacks, you have to think about ISIS. How concerned are you that ISIS has its sights on this type of attack?

SECRETARY AZAR: So, first, great question in terms of resources and statutory authority. And that’s actually one of the most important parts of this strategy. By having this coordinating committee that I, as Secretary of HHS, will chair, we’re going to be conducting immediately a review across all of the relevant agencies — so that’s Defense, State, Homeland Security, the Attorney General, EPA, Homeland Security, Agriculture — to basically get a survey of all of the activities going on in biodefense. And again, that’s natural, manmade, accidental threats.

So what are all of the activities going — a full, sort of, collection of what resources do we have deployed against it, and then where do we see gaps. So it is really the first-ever holistic look across the government to see where are we acting, and where might there be any gaps in light of our awareness of threats, our preparedness needs, and our ability to respond.

That will then inform the 2020 budget cycle. Obviously we’re later in the budget cycle. I think the biggest impact would be, as we look at the 2021 budget cycle, for a holistic look there for any gaps in funding, if we see any needs there.

I don’t want to — as Ambassador Bolton said with regard to ISIS, I don’t want to get into any particular actors. Obviously, we follow — we’re tightly connected in to ensure that awareness — that first element of the strategy — is critical to know who’s operating and also what they might be operating on.

MR. MARQUIS: Great. Is this a biodefense question?

Q Yes. Two biodefense questions. First, can you discuss why HHS was the proper home for biodefense rather than the Department of Homeland Security, which has a more traditional homeland security in the title? And then, secondly, you mentioned the threats. The State Department had previously stated publicly that China, Iran, North Korea, Russia, and Syria had not been complying with the Biological Weapons Convention. Is that still the assessment of the government? And then, why has the biological issue not been the subject of the President’s negotiations with Kim’s —

AMBASSADOR BOLTON: Well, on the second point, I can tell you we have said we want the elimination of all North Korea’s weapons of mass destruction programs, whatever they might be.

And to go to your first question — and Alex will probably want to expand on it — what we try and do when we create, across the board, national security strategies is pick the organizational structure that we think is most likely to achieve the objectives.

So in this case, we felt the evidence was overwhelming that we wanted a lead agency that would have the principal responsibility but would also be coordinating operational aspects with other departments and agencies that were involved. And the Department of Homeland Security is involved here.

But the overwhelming bulk of the scientific and technical expertise in the government on the range of biological threats we face — including, as the Secretary said, epidemiological threats, not just biological weapons attack — is in HHS. So every consideration that we could think of pointed to putting the lead responsibility in HHS, and that’s what we did.

Q You mentioned that the anthrax attacks of 17 years ago was indeed a domestic one done at a National Research Laboratory here by a scientist there.

It would seem to me that that is the single greatest potential threat. And also, coupled with that, is the fact that we have so many scientists from malign states who do university work in this country. What kind of scrutiny are those scientists given by the government?

SECRETARY AZAR: So, as you may know, there are different tiers of biological research facilities all the way up to what’s called biosecurity level 4, the most contained for the most dangerous select agents that we operate on. And that lab safety and control is something that at the Centers for Disease Control and Prevention out of Atlanta, that’s part of my department, we regulate and focus on lab security there.

So that’s actually a key part of the strategy. It’s good that you mentioned that — is the lab security here in the United States. There are a fair number of labs. We need to keep that. All of the great research that we do to advance biomedicine, and also even to prepare for countermeasures, has its opposite side, which is the threat potential. Exactly what you mentioned.

So that involves having to do background checks on individuals who may be touching select agents. There’s a whole regulatory regime — it’s called the Select Agent Regulation that CDC has — that controls the use transport of these more dangerous components that could be used in biological weapons.

Q Okay, and a quick follow-up. It would seem to me that the real canary in the coalmine here would be local hospitals and local public health officials. Are they enlisted in your plan?

SECRETARY AZAR: Oh, sure. That’s why state and local public health agencies, as well as the private sector, are critical to a coherent and comprehensive biodefense strategy. It’s not just the federal government.

The CDC really operates so much through our state and local partners, and that’s why we support public health epidemiological reporting, whether it’s in the opioid crisis or otherwise. Absolutely.

Q Secretary Azar, you mentioned for the first time that this also focuses on naturally occurring outbreaks, for example. So how much of this strategy is focusing on preparation to prevent the next big Ebola outbreak or any other global epidemics, for example, when, in fact, we know that CDC has been criticized for cutting back field works on Ebola countries? For example, I believe it’s down from 49 to 10 countries. So how prepared is the U.S. to deal with these kinds of naturally occurring epidemics when how big of this is part of this strategy?

SECRETARY AZAR: So, naturally occurring is very much a part of it, just like accidental, as well as manmade. And we’re heavily engaged internationally. The best way to stop a disease outbreak in the United States is by stopping it before it ever comes to our border by being engaged abroad.

So I would differ on that assessment around our Ebola engagement through the Global Health Security Agenda. The purpose of the Global Health Security Agenda has been to actually — it’s an international collaborative effort of which the United States is a very important and dedicated partner in that, under President Trump, to help other countries bring up their public health capabilities and infrastructure to comply with the modern international health regulations.

We are seeing the fruits of that today in the Democratic Republic of Congo. That is why the DRC itself diagnosed Ebola in both the earlier spring outbreak and the current one. They didn’t need the World Health Organization or the CDC to do that. They did that themselves. They have been leading the response. Of course, the World Health Organization and CDC are providing critical resources, as well as others, in the international community. But it was really the great work of the Global Health Security Agenda that’s making that possible.

And now you’ve moved to other countries. So as you build up infrastructure, public health surveillance, and operation center capabilities, you reprioritize and move — that’s the nature of it — as opposed to a permanent, enduring. Staying there, you work on building the rest of them up.

Q And just to follow up on the Global Health Security Agenda, is the U.S. prepared to extend that partnership when it expires in 2019, I believe? And —

SECRETARY AZAR: Oh, so we’ve already set our commitment as members of the Global Health Security Agenda. So, yes, we’re fully —

Q And what kind of funding —

SECRETARY AZAR: We’ll work with Congress on the appropriate levels of funding. We’re still working from the Ebola supplemental funding that provides the basis of the U.S. Global Health Security Agenda commitment. But we’ll be working with Congress on that. But we’re fully committed on the GHSA.

MR. MARQUIS: We have time for one more question. Vivian.

Q I have a question for both of you gentlemen. Ambassador Bolton, why now? I mean, is there something we need to know in terms of a credible threat to the United States? Something that prompted the administration to prioritize this currently?

And for Secretary Azar, you talked a lot about anthrax, 17 years ago. Is there any other new chemical agents? Technologies have obviously changed. Chemical — people are discovering things all the time. So is there something new that you have your eye on or you’re concerned about that we don’t know about in the public?

MR. BOLTON: Well, in terms of timing, this was actually mandated by statute sometime before. It was felt, I think, by my predecessors that it was important to do. Sometimes things take longer than one would like them to do. But when I came in, it was one of the things that I put a priority on to get interagency agreement. Secretary Azar has been a leader in this effort from the get-go.

And so that’s what’s brought it together now. No particular immediate threat, as you’ll see when you read the strategy, which is quite comprehensive. It reflects a lot of work that’s gone into it. And as I said, it’s intended to be a living document that we can revise and update in light of the circumstances.

SECRETARY AZAR: So the threats that we face — what makes biologic defense so interesting and perplexing is that the threats we face have often been around for millennia. And they just — modern techniques of control can be applied to them, as well as modification. So gene editing tactics, other — that, as I mentioned, the innovations in biomedical research that are so wonderful, that can bring so many therapies to us, are also tactics and techniques that can be used with ill will. But it can also be rather simple to use biologic agents. That’s the challenge of this and why we have to be so on our guard.

And the threat, as it was mentioned earlier, isn’t just from the manmade. We are, today, the 100th anniversary of the Great Flu Pandemic of 1918. It is important to remember that 25 percent of Americans were infected with the flu — the 1918 flu; 647,000 Americans in 1918 died from that flu.

I mean, if you’re extrapolating that to today, the numbers are actually — are catastrophic beyond anything we probably could imagine, even in terms of manmade in its dimension. That is also a part of this strategy of accidental, manmade, and naturally occurring disasters.

Q But that’s exacerbated by World War I, right? Towards the end of World War I, though. That’s how it made its way around the world, that pandemic.

MR. MARQUIS: I think that’s it, guys. Thank you so much.

Q But, I mean, isn’t that true?

MR. MARQUIS: Again, this is embargoed until 1 o’clock. You should expect an email from the White House with a factsheet, as well as the Biodefense Strategy.

Thank you so much everybody.

END

11:25 A.M. EDT