Blue Ribbon Study Panel on Biodefense
The Blue Ribbon Study Panel on Biodefense is a panel of former high-ranking government officials that analyzes US capabilities and capacity to defend against biological threats. According to the Panel'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." 
The Panel is supported by donor organizations. Hudson Institute serves as the Panel's fiscal sponsor. Current donors include Open Philanthropy.
- 1 Panel Members, Staff, and Ex Officios
- 2 Background
- 3 A National Blueprint for Biodefense
- 4 Identified problems
- 5 Recommendations
- 6 Other Reports
- 7 Activities
- 8 See also
- 9 References
- 10 External links
Panel Members, Staff, and Ex Officios
|Co-Chair||Joe Lieberman||United States 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||Tom Daschle||United States Senator, Senate Majority Leader, and Senate Democratic Leader|
|Panelist||Jim Greenwood||United States Representative, 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|
|Panelist||Lisa Monaco||Homeland Security Advisor, Counterterrorism Advisor, Assistant Attorney General for National Security|
|Former Panelist||Donna Shalala||United States Representative, Secretary of Health and Human Services|
|Executive Director||Asha M. George, DrPH||Subcommittee staff director and senior professional staff at the United States House Committee on Homeland Security, U.S. Army military intelligence officer and paratrooper|
|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|
|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|
|William Karesh, DVM||Executive Vice President for Health and Policy of EcoHealth Alliance, President of the World Organisation for Animal Health|
|Rachel Levinson, MA||Executive Director of National Research Initiatives at Arizona State University|
|Lewis "Scooter" Libby, JD||Senior Vice President of Hudson Institute, Assistant to Vice President Dick Cheney for National Security Affairs|
|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|
|George Poste, DVM, PhD, DSC||Director of the Complex Adaptive Systems Institute (CASI), Del E. Webb Professor of Health Innovation at Arizona State University|
|Tevi Troy, PhD||President of the American Health Policy Institute, Deputy Secretary of the U.S. Department of Health and Human Services|
Between 2001 and 2014, the U.S. spent around $80 billion on biodefense. Beginning in fall 2014, the Blue Ribbon Study Panel on Biodefense conducted meetings, interviews, and research. It studied the 2001 anthrax attacks and biodefense programs undertaken during the Clinton, Bush, and Obama Administrations.
In October 2015, the Panel released its recommendations to publicly and submitted them to Congress in the form of a report, A National Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize Efforts. They concluded that the United States was not prepared to respond to a large scale biological event - naturally occurring, accidentally released, or intentionally introduced. 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."
A National Blueprint for Biodefense
The Blue Ribbon Study Panel on Biodefense conducted a year-long study of how the U.S. should address biological threats. The study covered human-generated (i.e., terrorism, warfare, accidents) 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 many biological threats, including those posed by the Islamic State and Al Qaeda, as well as nation states, and "mishandling of lethal biological agents by the U.S. government," as reasons for making biodefense a high national priority. This report contained 33 recommendations and over 80 specific action items associated with those recommendations.
The report proposed congressional oversight hearings to address the following issues:
- Major biological threats
- Animal disease reporting
- Biomedical Advanced Research and Development Authority
- National Biodefense Strategy
- Budgeting for biodefense
- Cyber vulnerabilities to the life sciences industry
- Food supply protection and response
- Global health security and 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
On September 18, 2018, President Donald Trump released the 2018 National Biodefense Strategy and signed a National Security Presidential Memorandum to direct the federal government to execute this strategy. Together, they will improve the federal government's readiness and response to human-generated and naturally occurring biological threats to the Nation. The Strategy was mandated by Congress and has five extensively detailed goals. It establishes a new cabinet-level committee chaired by the Secretary of the U.S. Department of Health and Human Services. National Security Advisor John Bolton said, "The Biodefense Steering Committee will monitor and coordinate implementation of the National Biodefense Strategy across 15 federal agencies and the intelligence community." The Blue Ribbon Study Panel on Biodefense commended the Trump Administration for creating the strategy in accordance with the Panel's third recommendation in its National Blueprint for Biodefense.
In the Blueprint for Biodefense report, the Panel said that almost no urgency within the federal government for dealing with the risk of a biological event existed.
The report stated that the government does not appear to take events related to biodefense 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 Panel recommendations would be that the report would serve as a "guidebook for placing blame."
The federal government has also failed 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, during a hearing with the Senate Committee on Homeland Security and Governmental Affairs, Governor Tom Ridge stated 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. Nation states and terrorist organizations are already able to "merge the toxic attributes of more than one agent." To replace vaccine stockpiles, the Panel recommended a "vaccines-on-demand approach."
The Panel held a public meeting on October 3, 2017 about the biological attribution of crime, terrorism, and warfare. Biological attribution refers to the process of determining who and what was responsible for a biological attack. Perpetrators could be criminals, terrorists, or state actors. During this meeting, the Panel learned about the federal government's existing capabilities to determine the sources and characteristics of deadly pathogens. The Panel has taken a particular interest in the National Bioforensics Analysis Center (NBFAC). In fiscal year 2013, the NBFAC supported more than 45 investigations of potential biological crimes. Previously run by the Department of Homeland Security (DHS), the Panel recommended that the Federal Bureau of Investigation (FBI) assume management of the NBFAC, as today, 100% of all specimens going into the facility come from the FBI. In 2018, DHS and the FBI signed a memorandum of agreement that transferred NBFAC management to the FBI.
Budgeting for biodefense
In its February 2018 report, Budget Reform for Biodefense: Integrated Budget Needed to Increase Return on Investment, the Panel noted increasing threats to the United States and its interests overseas, and determined that 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 released its report to the public and Congress in 2018.
One of the key budgeting issues identified by the Panel is that there all federal departments and many agencies have some biodefense responsibilities. Despite this multiplicity, there is not enough coordination. The Office of Management and Budget (OMB), co-chair Senator Lieberman said, does not 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." In 2019, congressional Appropriations directed OMB to conduct a biodefense budget cross-cut that would inform the budget request, in accordance with one of the Panel's recommendations. While the report also asks Congress to create a bipartisan, bicameral Biodefense Working Group to come up with budgeting solutions, Congress has yet to establish such a Group. The House of Representatives, however, has established a Biodefense Caucus.
Large-scale national preparedness
Panel members and experts agreed during a public Panel meeting in January 2018 that in order to respond effectively during a large-scale biological event due to a terrorist attack or natural disaster, the public and private sectors need to coordinate. The Panel also noted that obstacles exist that highlight the nation's vulnerabilities to such an event. The Panel concluded that a comprehensive public health system that is able to respond before a biological disaster strikes is critical.
In an op-ed in the Miami Herald on January 15, 2018, former Secretary of Health and Human Services Donna Shalala said 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 biological disaster hospital 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," speakers told members of the Blue Ribbon Study Panel on Biodefense in a January 2018 public meeting, according to Homeland Preparedness News. The public hearing occurred during the same week that the Senate began holding hearings on the Pandemic and All-Hazards Preparedness Act (PAHPA), which was due for reauthorization in September 2018. Information 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 Panel recommended that the federal government "redouble its efforts to share information with SLTT governments" and described variuos action items to do so.
The National Blueprint for Biodefense, laid out 33 recommendations and associated action items. The primary actions the U.S. government should take, according to the Panel's report, are the following:
|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 the Panel's major recommendations was to place responsibility for 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 making the Vice President responsible for biodefense, 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 the Panel that would merge strategies for dealing with human and animal health biodefense programs.
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, the Panel 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 addressed by a single comprehensive strategy. By different types, they meant biological warfare, bioterrorism, naturally occurring deadly disease, and accidental release.
Since the release of its National Blueprint for Biodefense, the Panel has released four 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, and Holding The Line On Biodefense: State, Local, Tribal, and Territorial Reinforcements Needed (October 2018).
In Holding the Line on Biodefense, the Panel made 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. Senator Lieberman believes that a biological attack is imminent.
The Panel's bipartisan activities include meetings, research, issuing reports, testifying before Congress, and meeting with officials at the White House.
Dr. George said that that the Panel would stay engaged with Congress to help it understand and make the improvements that the Panel recommended.
Previously, the Panel teamed up with the Alliance for Biosecurity, and Trust for America's Health to conduct a survey of Americans' thoughts about biosecurity. According to the Alliance, Americans are concerned about biological threats.
In September 2016, the Open Philanthropy Project gave 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." In February 2018, the Open Philanthropy Project gave the Panel another grant for $2.5 million to advance biodefense leadership and reduce catastrophic biological risk. “Estimates show that as many as 100 million people died in 1918 from pandemic influenza,” said Senator Joe Lieberman. “That was before we were traveling as often as we do today, and well before commerce became globalized. Since then, the world has gotten smaller, but the threat has not. Far more needs to be done to prepare for another catastrophic biological event – whether manmade or from nature. With this in mind, the support we receive today from Open Philanthropy will allow us to further advance the recommendations the Panel identified in our National Blueprint for Biodefense and subsequent reports. We thank Open Philanthropy for their leadership and support on this critical issue.”
In December 2018, President Trump signed the Agricultural Improvement Act of 2018 (H.R. 2), also known as The Farm Bill. The legislation addressed Panel recommendations to defend U.S. food and agriculture. The new law creates a National Animal Disease Preparedness and Response Program and a National Animal Vaccine and Veterinary Countermeasures Bank, and increases federal funding to stockpile medical countermeasures for animals.
- 9/11 Commission
- Biological hazard
- Biological warfare
- Blue-ribbon panel
- Pandemic influenza
- United States biological defense program
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- Report - "A National Blueprint for Biodefense" (2015)
- Report - "Biodefense Indicators: One Year Later, Events Outpacing Federal Efforts to Defend the Nation" (2016)
- Report - "Defense of Animal Agriculture" (2017)
- Report - "Budget Reform for Biodefense: Integrated Budget Needed to Increase Return on Investment" (2018)
- Report - "Holding the Line on Biodefense: State, Local, Tribal, and Territorial Reinforcements Needed" (2018)
- Blue Ribbon Study Panel on Biodefense on Facebook
- "Defending Against Bioterrorism: How Vulnerable is America?" House Committee on Homeland Security hearing (2015)
- Hearing on Biodefense Preparedness (with witnesses from BRSPB) on C-SPAN (video)
- Panel Discussion on Bioterrorism, Pandemics, and Preparing for the Future - moderated by author Max Brooks (2017)