Social:Blue Ribbon Study Panel on Biodefense

Former U.S. Senator Joe Lieberman addresses biodefense with former Secretary of Homeland Security Tom Ridge, former Secretary of Health and Human Services Donna Shalala, former Homeland Security Advisor Kenneth L. Wainstein, and former Congressman James C. Greenwood at Hudson Institute in 2015

The Blue Ribbon Study Panel on Biodefense (BRSPB) is a panel of former high-ranking government officials and academic experts that analyzes the United States' defense capabilities against biological threats. According to BRSPB's mission statement, the organization was formed to "provide for a comprehensive assessment of the state of U.S. biodefense efforts, and to issue recommendations that will foster change."

BRSPB is supported by donor organizations. Hudson Institute serves as the Panel's fiscal sponsor. Current donors include Open Philanthropy.

Panel Members, Staff, and Ex Officios

Senator Joe Lieberman

Governor Tom Ridge

The BRSPB is co-chaired by former Senator Joe Lieberman and former Governor Tom Ridge.

Role	Name	Experience
Co-Chair	Joe Lieberman	U.S Senator, Chairman of the Senate Committee on Homeland Security and Governmental Affairs, Democratic candidate for President of the United States and Vice President of the United States
Co-Chair	Tom Ridge	Secretary of Homeland Security. Governor of Pennsylvania, United States Representative
Panelist	Donna Shalala	Secretary of Health and Human Services
Panelist	Tom Daschle	United States Senator, Senate Majority Leader, and Senate Democratic Leader
Panelist	Jim Greenwood	Chairman of the Subcommittee on Oversight and Investigation, House Committee on Energy and Commerce, Pennsylvania General Assembly Member, Pennsylvania State Senator
Panelist	Kenneth Wainstein	Homeland Security Advisor, Assistant Attorney General for National Security
Executive Director	Asha M. George, DrPH	Subcommittee staff director at the United States House Committee on Homeland Security, U.S. Army military intelligence officer and paratrooper, government contractor
Policy Associate	Robert Bradley	Professional Staff at the United States Senate Committee on Homeland Security and Governmental Affairs
Panel Coordinator	Patty Prasada-Rao	Chief Operating Officer at the Christian Community Development Association (CCDA), staff at New Song Ministries, Sandtown
Event Coordinator	Patricia de la Sota	Senior Operations Officer and Trainer at the CIA
Advisor	Ellen Carlin, DVM	Professional Staff at the United States House Committee on Homeland Security, Health and Policy Specialist at EcoHealth Alliance
Ex Officio Member	Yonah Alexander, PhD	Director of the Inter-University Center for Terrorism Studies and Senior Fellow at the Potomac Institute for Policy Studies, Professor of international studies
Ex Officio Member	William Karesh, DVM	Executive Vice President for Health and Policy of EcoHealth Alliance, President of the World Organization for Animal Health
Ex Officio Member	Rachel Levinson, MA	Executive Director of National Research Initiatives at Arizona State University
Ex Officio Member	Lewis "Scooter" Libby, JD	Senior Vice President of Hudson Institute, Assistant to Vice President Cheney for National Security Affairs
Ex Officio Member	Gerald Parker, DVM, PhD	Senior Fellow for the Pandemic and Biosecurity Policy Programs at the Scowcroft Institute of International Affairs, The Bush School of Government & Public Service at Texas A&M University; Associate Dean of Global One Health at the Texas A&M College of Veterinary Medicine & Biomedical Sciences; Strategic Advisor for the Institute for Infectious Animal Diseases (IIAD) at Texas A&M AgriLife Research
Ex Officio Member	George Poste, DVM, PhD, DSC	Director of the Complex Adaptive Systems Institute (CASI), Del E. Webb Professor of Health Innovation at Arizona State University
Ex Officio Member	Tevi Troy, PhD	President of the American Health Policy Institute, Deputy Secretary of the U.S. Department of Health and Human Services

Sources:

Background

Between 2001 and 2014, the U.S. spent around $80 billion on biodefense. Beginning in fall 2014, the BRSPB conducted meetings, interviews, and conducting research. It studied the 2001 anthrax attacks and each biodefense program enacted under Presidents Bill Clinton, George W. Bush, and Barack Obama.

In October 2015, BRSPB submitted its recommendations to Congress in the form of a report, A National Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize Efforts. The conclusion was that the United States was not prepared to respond to a biological weapon attack. As for the cause of the problem, the report said, "Simply put, the nation does not afford the biological threat the same level of attention as it does other threats."

National Blueprint for Biodefense

BRSPB conducted a year-long study of how the U.S. should address biological threats. The study covered human-generated (terrorist and accidental) and naturally occurring biological threats. The study culminated in a report to the public and Congress released on October 28, 2015.

The group's report was titled A National Blueprint for Biodefense. The report described threats posed by the Islamic State, as well as "mishandling of lethal biological agents by the U.S. government," as reasons for making biodefense preparedness a higher national priority. BRSPB's final report had 33 recommendations and over 80 specific items associated with those recommendations.

The report proposes congressional oversight hearings on the following list of issues:

• Major threats
• Animal disease reporting
• Biomedical Advanced Research and Development Authority
• Biodefense strategy
• Biosurveillance
• Budgeting
• Cyber vulnerabilities to the life sciences industry
• Food supply protection and response
• Global health response
• Medical countermeasures (MCM) innovation
• Military-civilian biodefense collaboration
• Origin of active pharmaceutical ingredients (API)
• PHEMCE coordination of MCM efforts
• Select Agent Program
• Vulnerable populations

Identified problems

The international symbol for biological hazard.

The BRSPB report said that there existed almost no urgency within the federal government for dealing with the risk of a biological event.

The report stated that the government does not appear to take events related to biological safety seriously enough. One member stated, "The tragic saga of the death of Thomas Eric Duncan from Ebola Virus Disease (EVD) serves as a perfect demonstration of the shambolic state of biodefense in the United States in late 2014." Another estimated that the consequences of inaction on BRSPB's recommendations would be that the report would serve as a "guidebook for placing blame."

Another issue is the federal government's failure to update its practices and procedures as they relate to biological threats. For example, there is a system within the National Institutes of Health and Food and Drug Administration that would fast-track the approval of medical countermeasures in the event of a biological attack. However, Tom Ridge told a Senate committee during a hearing that the fast-track process is obsolete. Page 52 of the report reads, "A systemic, risk averse culture has emerged that is stifling innovation. If this continues to evolve, progress on biodefense objectives will be curtained and the still nascent biodefence industry will have little incentive to participate."

Another example is the practice of stockpiling vaccines against a biological agent. This practice is now considered obsolete, the BRSPB opined. Terrorist organizations are already able to "merge the toxic attributes of more than one agent." To replace vaccine stockpiles, BRSPB recommended a "vaccines-on-demand approach."

Biological attribution

The panel held a hearing on October 3, 2017 about the threats, challenges and solutions to an issue known as biological attribution, which refers to the process of determining who was responsible for a biological attack. Perpetrators could be criminals, terrorists, or state actors. The panel used the hearing, which included expert witnesses, to learn about the federal government's existing capabilities to figure out the sources of deadly pathogens and what those pathogens are.

In fiscal year 2013, the NBFAC supported more than 45 investigations of potential biological crimes.

Budgeting

Myriad federal departments and agencies are responsible for defending against these threats. Referring to their activities as a federal biodefense enterprise suggests a coordinated interagency endeavor unified in achieving common goals, but this is not the reality that exists currently. America is more vulnerable today than it should be to a biological crisis of any scale.

—Blue Ribbon Study Panel on Biodefense, February 2018 report

In its February 2018 report called Budget Reform for Biodefense: Integrated Budget Needed to Increase Return on Investment, the panel concluded that with threats to the U.S. and its interests overseas going up, the U.S. government can no longer wait to commit federal funds to biodefense; waiting is not in the best interest of the health of Americans nor the country's national security. The panel submitted its report to Congress.

One of the key budgeting issues is that there are too many separate agencies working on biodefense, and not enough coordination. The Office of Management and Budget (OMB), Chairman Joe Lieberman said, doesn't know how much the federal government spends on biodefense because "the sad fact is, more than two dozen agencies are working in silos across biodefense; that increases our vulnerabilities. Once we have a strategy and match that strategy with budget reforms ... that's the beginning of a much more effective biodefense national strategy." Economic impacts of a catastrophic outbreak could reach $1 trillion, Lieberman noted.

The report recommends that the OMB each year submit "an integrated budget request to Congress that outlines federal-wide biodefense spending, and how it is tied to mission objectives." The report also asks Congress to create a bipartisan, bicameral Biodefense Working Group to come up with budgeting solutions.

Large-scale national preparedness

In order to respond effectively during a large-scale biological event such as a terrorist attack or natural disaster, public and private organizations need to coordinate, experts on the panel agreed during a January 2018 hearing. However, obstacles exist that highlight the nation's vulnerabilities to such an event.

Hosted by panel members Donna Shalala, former Secretary of Health and Human Services, and former U.S. Rep. Jim Greenwood, officials concluded that a comprehensive public health system that is able to respond before a true biological disaster strikes is critical. The panel released an important report in 2015 called "A National Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize Efforts." The report showed the gap's in the United States' capabilities to respond to a biological event and recommended changes to U.S. biodefense policies.

In an op-ed in the Miami Herald on January 15, 2018, Shalala wrote that during a large biological event, "I know that the federal government would move resources to affected areas throughout the United States. But those resources are already too few, and the federal government does not respond quickly to multiple locations in distress."

National disaster health care system

A "stratified biodefense hospital system would provide the United States with a protective shield in the event the country experiences a man-made or natural biological catastrophe", panelists told members of the Blue Ribbon Study Panel on Biodefense in a January 2018 public meeting, according to Homeland Preparedness News. The hospital system was one suggestion that panelists asked the study panel to take to Congress to act upon. The public hearing occurred during the same week that the U.S. Senate began holding hearings on the Pandemic and All-Hazards Preparedness Act (PAHPA), which is due for reauthorization in September 2018. Sharing across state, local, tribal, and territorial (SLTT) governments was another large theme during the public meeting. In its December 2016 Biodefense Indicators report, the study panel recommended that the White House "redouble its efforts to share information with SLTT governments and listed specific action points for how to do so."

Recommendations

The National Blueprint for Biodefense, laid out a series of recommendations and associated action items. The primary changes the U.S. government should take, according to the panel's report, are the following:

Number	Recommendation	Specific Action
1	Institutionalize biodefense in the Office of the Vice President of the United States	Empower the Vice President with jurisdiction and authority over biodefense responsibilities.
2	Establish a Biodefense Coordination Council at the White House, led by the Vice President	The Vice President should lead the primary designees and the members as a coalition that will prioritize needed activities, designate responsibilities, and ensure accountability.
3	Develop, implement, and update a comprehensive national biodefense strategy	The Vice President should develop a comprehensive national biodefense strategy and implementation plan.
4	Unify biodefense budgeting	Congress should mandate the development of a unified budget that defines how the entire biodefense enterprise is funded.
5	Determine and establish a clear congressional agenda to ensure national biodefense	At the start of each congressional session, Senate and House leadership should direct each committee with biodefense jurisdiction to convene for an in-depth classified biological threat briefing.
6	Improve management of the biological intelligence enterprise	The Director of National Intelligence should address the biological threat in the same way that other issues have been handled that cut across multiple intelligence agencies. This includes creating a national intelligence manager for biological threats, making the biological weapons programs a discrete intelligence topic, addressing bystanders, and distributing assessments.
7	Integrate animal health and One Health approaches into biodefense strategies	The White House should lead all relevant agencies to a new level of understanding, planning, and operating with respect to biodefense that includes an animal health and, more broadly, a One Health mindset. The executive branch should also develop a nationally notifiable animal disease system and prioritize emerging as well as reemerging infectious diseases.
8	Prioritize and align investments in medical countermeasures among all federal stakeholders	The Vice President should ensure that Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) priorities guide NIH biodefense research investments. The Vice President should also ensure funding allocations that address biological agents are met and require a biodefense spending plan from the National Institute of Allergy and Infectious Diseases.
9	Better support and informed decisions based on biological attribution	The Vice President should direct the Secretary of State, Secretary of Defense, Secretary of Homeland Security, the Attorney General, and the DNI to establish and formalize this apparatus. The FBI should also take charge of the national Bioforensics Analysis Center.
10	Establish a national environmental decontamination and remediation capacity	The Vice President should ensure the Federal Emergency Management Agency is included in interagency efforts to determine policy on biological attacks. Congress should place the EPA in charge of environmental decontamination and remediation efforts after accidental releases and biological attacks. And both the Vice President and Congress should delegate studies of those exposed to disease-causing agents.
11	Implement an integrated national biosurveillance capability	The plan must identify information required by decision makers (federal, state, local, territorial, tribal, private sector) to manage a biological event.
12	Empower non-federal entities to become equal biosurveillance partners	The Secretary of Homeland Security should create an interagency biosurveillance planning committee the nexus for active collaboration with non-federal government and non-governmental partners.
13	Optimize the National Biosurveillance Integration System (NBIS)	The National Security Council should immediately examine NBIS to determine whether expenditures have yielded sufficient amounts of useful information to decision makers beyond the Department of Homeland Security. The NSC should also convene data owners and other stakeholders to evaluate incentive options and determine which are most viable for data and information sharing.
14	Improve surveillance of and planning for animal and zoonotic outbreaks	Congress should increase opportunities for animal health data collection and optimize funding for the National Animal Health Laboratory Network. The CDC and FEMA should then develop guidance for states, localities, territories, and tribes to handle companion animal infections in the event of a major zoonotic disease outbreak.
15	Provide emergency service providers with the resources they need to keep themselves and their families safe	The Secretary of Homeland Security must ensure that emergency service providers have access to anthrax vaccines and extend the program to meet other threats. The CDC, FDA and ASPR should preposition medkits with emergency service providers and their families. And the Secretary of Health and Human Services should establish reasonable personal protective equipment guidelines and requirements in advance of a biological event.
16	Redouble efforts to share information with state, local, territorial, and tribal partners	The government should strengthen the Joint Counterterrorism Assessment Team, local police intelligence units and provide technical assistance to fusion centers to provide biological information and intelligence.
17	Fund the Public Health Emergency Preparedness cooperative agreement at no less than authorized levels	Congress should appropriate the Public Health Emergency Preparedness funding to authorized levels or the President's request, whichever is higher.
18	Establish and utilize a standard process to develop and issue clinical infection control guidance for biological events	Congress should standardize the development of clinical infection control guidelines before biological events occur. The Secretary of Health and Human Services and the Secretary of Labor should also Institute a process for obtaining and incorporating feedback regarding clinical infection control guidelines during biological events as well as require training based on these guidelines.
19	Minimize redirection of Hospital Preparedness Program (HPP) funds	Congress should amend the Public Health Service Act to require that no less than 97 percent of appropriated HPP funds go directly to HPP grantees. Congress should also regularly assess the program.
20	Provide the financial incentives hospitals need to prepare for biological events	The government should adopt a disaster preparedness portfolio that includes the Conditions of Participation, Interpretive Guidance, measures development for inclusion within value-based purchasing, and innovation projects. Congress should also link Centers for Medicare and Medicaid Services incentives and reimbursement to new accreditation standards.
21	Establish a biodefense hospital system	The Secretary of Health and Human Services should establish a stratified system of hospitals with increasing levels of capability to treat patients affected by bioterrorism and other events involving highly pathogenic infectious diseases. The Administrator of Centers for Medicare and Medicaid Services should develop new standards to accredit hospitals and provide funding accordingly.
22	Develop and implement a Medical Countermeasure (MCM) Response Framework	Together with non-federal partners, the ASPR, the Director of the CDC, and the Administrator of FEMA should identify requirements and capacities needed to achieve successful distribution and dispensing of MCM from the Strategic National Stockpile as well as from local caches.
23	Allow for forward deployment of Strategic National Stockpile assets	The Director of the CDC should determine the necessary assessment, logistical, and funding requirements to forward deploy Strategic National Stockpile assets.
24	Harden pathogen and advanced biotechnology information from cyber attacks	The Vice President should develop and implement a security strategy for stored pathogen data and cyber-threat information-sharing mechanisms for the pathogen and advanced biotechnology communities. In turn, Federal departments and agencies should include federally-supported pathogen research projects in the revised procurement model under development.
25	Renew U.S. leadership of the Biological and Toxin Weapons Convention (BWC)	The government should continue to strengthen implementation of the BWC where U.S. support is unequivocal, set U.S. goals for the BWC and determine the conditions necessary to achieve them, develop three actionable recommendations for BWC verification, and establish better biological weapons sentencing guidelines in statute.
26	Implement military-civilian collaboration for biodefense	The government should conduct a review of military-civilian collaborative efforts, mandate military-civilian collaboration on biodefense (including research regarding force protection), clarify parameters for military support to civilian authorities in response to a domestic biological attack, and update and implement military biodefense doctrine.
27	Prioritize innovation over incrementalism in medical countermeasure development	The government should prioritize innovation and funding for medical countermeasures at agencies with biodefense responsibilities, identify at least five promising novel technologies that could ultimately be applied to MCM development for material threats, revolutionize development of medical countermeasures for emerging infectious diseases with pandemic potential, and establish an antigen bank.
28	Fully prioritize, fund, and incentivize the medical countermeasure enterprise	The government should fund the medical countermeasure enterprise to no less than authorized levels, re-establish multi-year biodefense funding for medical countermeasure procurement, address prioritization and funding for influenza preparedness, and improve the plan for incentivizing the private sector and academia.
29	Reform Biomedical Advanced Research and Development Authority contracting	Contracting authority should be the exclusive responsibility of the Biomedical Advanced Research and Development Authority (BARDA). In addition, BARDA should prioritize the use of OTA and consider any other appropriate flexible contracting authorities for BioShield. Congress should then eliminate the Office of Management and Budget review of BioShield procurements.
30	Incentivize development of rapid point-of-care diagnostics	The Director of BARDA should determine the suite of rapid diagnostics that are needed for biological agents determined to be material threats and emerging infectious diseases.
31	Develop a 21st Century-worthy environmental detection system	Congress, through its appropriations to DHS and DOD, should fund an advanced environmental detection system capable of rapid agent characterization and confirmation. The Secretary of Homeland Security should also replace BioWatch Generation 1 and 2 detectors within five years.
32	Review and overhaul the Select Agent Program	Congress should direct the National Science Advisory Board for Biosecurity to undertake a systematic, evidence-based assessment and overhaul of the Select Agent Program.
33	Lead the way toward establishing a functional and agile global public health response apparatus	The Secretary of State should convene human and animal health leaders from throughout the world to evaluate current mechanisms and develop a strategy and implementation plan for global public health response.

One of BRSPB's major recommendations was to place responsibility of biodefense leadership into the hands of the Office of the Vice President of the United States. By doing so, biodefense would have "the ear of the president and the ability to coordinate budgets and plans across agencies". In such a scenario, the White House Biodefense Coordination Council would execute the day-to-day work, Senator Lieberman said during testimony in front of the House Homeland Security Committee. By placing responsibility for biodefense in the hands of the Vice President's office, it would "transcend the bureaucratic and budgetary rivalries of various agencies in order to create an effective platform for dealing with biological attacks."

The report also suggested that the government merge duplicate processes by including all biological threats, not just those from terrorism, into a national strategy. For example, the "OneHealth approach" is one recommendation made by BRSPB that would merge strategies for dealing with human and animal health biodefense programs.

Aerial photo of the National Institutes of Health Mark O. Hatfield Clinical Research Center in Bethesda, Maryland

The Blue Ribbon Study Panel on Biodefense also called for the new Innovation Funds at the National Institutes of Health, and for ten percent of those funds to be dedicated to building technology that would allow multiple antigens in a countermeasure to be delivered from a single platform. Similarly, BRSPB called for ten percent of funds from the Biomedical Advanced Research and Development Authority (BARDA) for the same purpose.

Dr. George told Homeland Prep News that in order for the government's defense against a biological attack to be sufficient, a new comprehensive program needs to be developed. The programs and activities under a new approach would need to be "coordinated, collaborative and innovative." The report recommends that all types of biological threats should be included in a single, command-and-control strategy. By different types, they meant "biological warfare, bioterrorism, pandemic illness, and accidental release."

Other Reports

Since the release of its National Blueprint for Biodefense, the Panel has released three other reports: Biodefense Indicators: One Year Later, Events Outpacing Federal Efforts to Defend the Nation (December 2016); Defense of Animal Agriculture (October 2017); and Budget Reform for Biodefense: Integrated Budget Needed to Increase Return on Investment.

The BRSBP published a report called "Holding The Line On Biodefense: State, Local, Tribal, and Territorial Reinforcements Needed" in October 2018. The study makes eight recommendations to improve the U.S. biodefense system. One of the recommendations is to distribute funds to various levels of government before, not after, a biological event, in order to emphasize preparedness. Lieberman said that a major bioterrorism attack is "imminent."

Activities

The panel's activities include research, discussion meetings, issuing a report, and testifying before Congress. The group held four meetings in which it discussed the current status of the country's biodefense efforts.

Dr. George said that for 2016, BRSPB would focus its efforts on staying engaged with Congress to help it understand and make the improvements that the BRSPB report outlined.

Additionally, BRSPB teamed up with the Alliance for Biosecurity and Trust for America' Health to conduct a survey of Americans' thoughts about biosecurity. According to the Alliance for Biosecurity, Americans are concerned about biological threats.

In September 2016, the Open Philanthropy Project granted the panel a $1.3 million grant in support of the panel's influential leadership role in the evaluation of the nation's biodefense systems. Tom Ridge said, "It is troubling that we still do not have a comprehensive approach to preparing for and responding to biological events. That is why this grant from Open Philanthropy is so critical. It will allow us to push forward the recommendations detailed in our National Blueprint and seek to put them into action."

See also

• 9/11 Commission
• Biological hazard
• Bioterrorism
• Blue-ribbon panel
• Terrorism
• United States biological defense program
• United States Department of Homeland Security

External links

• Official report - "A National Blueprint for Biodefense"
• Blue Ribbon Study Panel on Biodefense on Facebook
• Budget Reform for Biodefense: Integrated Budget Needed to Increase Return on Investment report. February 2018 report published by the study panel.
• "Defending Against Bioterrorism: How Vulnerable is America?" House Homeland Security Committee hearing (November 3, 2015)
• Hearing on Biodefense Preparedness (with witnesses from BRSPB) on C-SPAN (video)