"Accelerating Medical Countermeasures." CSIS Commission on Strengthening America's Health Security, Center for Strategic and International Studies, September 13, 2018. Accessed April 09, 2019. https://healthsecurity.csis.org/articles/accelerating-medical-countermeasures/
According to a 2016 report from the Trust for America’s Health, 40 percent of states lack backup medical supplies to cope with a pandemic influenza or other major outbreak.[^1] The 2018 flu highlights critical shortfalls in the vaccine and medical product supply chain. Dependent upon imports for 75-80 percent of raw materials for drugs, the United States remains vulnerable to shortages and an uncertain ability to meet sudden surges in demand.[^2]
Development Time and Resources
The time and resources required for developing countermeasures are formidable. Developing a new commercial vaccine or drug can take more than 10 years and cost over $1 billion, though that is not always the case and debate continues over R&D data and true costs.1 HHS estimates that the failure rate for development and licensure of most drugs, vaccines, and diagnostic devises in the early development stage can be more than 80 percent (though odds of success rise as product development advances).2
The U.S. Biomedical Advanced Research and Development Authority (BARDA) has supported the development of over 190 candidate products since its creation in 2006 at costs below the high upper levels cited above.3 Of these, 34 candidates have already been approved by the FDA,4 and 14 have been added to the Strategic National Stockpile.5 However, constrained budgets and the increase of maintenance and replenishment costs can reduce the funding available to BARDA for the development and stockpiling of new drugs.6
U.S. Government Fragmentation
Roles and responsibilities for countermeasures are distributed across multiple U.S. government agencies. The Department of Health and Human Services (HHS) leads the federal public health and medical response to potential CBRN threats and emerging infectious disease. HHS is responsible for assessing the potential health consequences of any CBRN agent that the Department of Homeland Security (DHS) determines to pose a threat sufficient to affect national security. HHS created the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) in 2006 as an interagency body with participants from HHS, DOD and DHS to advise the Secretary of Health and Human Services on countermeasure priorities and approaches.7 BARDA coordinates and supports advanced research and development, manufacturing, and initial procurement of countermeasures. The CDC maintains the Strategic National Stockpile. FDA assesses the safety and efficacy of countermeasures and makes the primary determination of the safety and efficacy of countermeasures. DOD is responsible for research, development, and acquisition of medical countermeasures for armed forces personnel.8
The distribution of countermeasure responsibilities across multiple U.S. government agencies complicates responsibility and accountability across the different complex processes that create countermeasures. Budgets and authorities are fragmented. The multiple agencies and departments assess priority threats and risks differently. There is also insufficient alignment of materials transfer agreements within the U.S. government. No single office or agency has the authority to sustain the entire process and ensure surveillance, detection, deployment, clinical trials, and regulations are effectively managed from beginning to end.
Private Sector Engagement and Federal Funding
The private sector plays an essential role in the development of medical countermeasures. Preparedness against chemical, biological, radiological, or nuclear threats require sustained and integrated approaches across the public and private sectors. The only market for medical countermeasures for a bioterror event is the federal government. Lack of sustainability, reliability, and flexibility in federal funding creates frustration and undermines confidence among private sector partners.
Without reliable and predictable U.S. funding, it remains exceedingly difficult to research, develop, and distribute new or innovative medical countermeasures, let alone reliably maintain current approaches.9 When operating under a Continuing Resolution (CR), managers have limited leeway for new initiatives. When late appropriations occur, as was just recently the case for FY2018, managers can suddenly face the need to expedite a surge of additional funding. Neither scenario makes sense from an efficiency and long-range planning perspective.
For private sector partners, sustainable financing reduces market risks by defining the minimum economic value of a product. Interruptions in funding creates doubt over future federal government purchases, and when the market for countermeasures is limited or uncertain, the private sector has insufficient incentive to invest. Private sector investors are loath to invest incrementally in the development of new products with uncertain long-term markets.
Across the many studies of the international response to the Ebola epidemic, there was a common conclusion: there needs to be major new efforts to mobilize significant capital in support of new mechanisms that could strategically plan ahead for the development of new countermeasures.
Over 20 organizations have been established over the last ten years to stimulate development and coordination of countermeasures. WHO created the Research & Development Blueprint in 2016 to encourage rapid activation of R&D activities during epidemics and to fast-track the availability of tests, vaccines and medicines.10 While these new alliances, institutions, and NGOs play an essential role, the challenge remains to coordinate efforts and investments and minimize redundancy.
One promising new effort is the Coalition for Epidemic Preparedness Innovations (CEPI), an alliance launched in early 2017.11 With early capital pledges of $630 million, CEPI is prioritizing the development of two kinds of vaccines in its first five years: “just in case” vaccines developed to combat a single pathogen (CEPI has chosen to focus on vaccines for MERS-CoV, Lassa, and Nipah viruses) and “just in time” vaccines focusing on the development and validation of versatile and fast R&D platform technologies that can be applied to a range of infectious diseases, including a currently unknown Pathogen X, in the event of a potential epidemic. Speed is essential: these platforms need to be able to produce a vaccine for testing within a maximum of 16 weeks from identification and sequencing of a novel pathogen.
Tom Daschle, Judd Gregg, G. William Hoagland, and Anand Parekh, “Budgeting for Medical Countermeasures: An Ongoing Need for Preparedness,” Bipartisan Policy Center, February 2018, https://bipartisanpolicy.org/wp-content/uploads/2018/02/BPC-Health-Budgeting-For-Medical-Countermeasures-An-Ongoing-Need-For-Preparedness.pdf ↩
Cynthia Bascetta, “Public Health Preparedness: Developing and Acquiring Medical Countermeasures Against Chemical, Biological, Radiological, and Nuclear Agents (Testimony Before the Subcommittee on Emergency Preparedness, Response, and Communications, Committee on Homeland Security, House of Representatives),” GAO-11-567T, April 13, 2011, https://www.gao.gov/assets/130/126034.pdf ↩
HHS ASPR, “Fiscal Year 2018 Budget-in-Brief: Public Health and Social Services Emergency Fund,” 2018, https://www.phe.gov/about/ofpa/Documents/bib-2018.pdf ↩
Rick Bright, “Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza (Written Testimony for the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations),” HHS ASPR, March 8, 2018, https://docs.house.gov/meetings/IF/IF02/20180308/106967/HHRG-115-IF02-Wstate-BrightR-20180308.pdf ↩
HHS ASPR, “Fiscal Year 2018 Budget-in-Brief: Public Health and Social Services Emergency Fund.” ↩
National Biodefense Science Board and Office of Public health Preparedness and Response Board of Scientific Counselors, “Anticipated Responsibilities of the Strategic National Stockpile (SNS) in the Year 2020: An Examination with Recommendations,” April 2013, https://www.phe.gov/Preparedness/legal/boards/nprsb/recommendations/Documents/nbsb-bsc-sns-2020-final.pdf ↩
Bascetta, “Public Health Preparedness: Developing and Acquiring Medical Countermeasures Against Chemical, Biological, Radiological, and Nuclear Agents (Testimony Before the Subcommittee on Emergency Preparedness, Response, and Communications, Committee on Homeland Security, House of Representatives).” ↩
Daschle, Gregg, Hoagland, and Parekh, “Budgeting for Medical Countermeasures: An Ongoing Need for Preparedness.” ↩
WHO, “An R&D Blueprint for Action to Prevent Epidemics: Plan of Action,” May 2016, http://www.who.int/blueprint/about/r_d_blueprint_plan_of_action.pdf?ua=1 ↩