Twenty years ago, Congress established the Strategic National Stockpile (SNS), originally named the National Pharmaceutical Stockpile, with a $51 million appropriation and a handful of staff quietly housed in CDC’s National Center for Environmental Health. Today, the SNS is part of the HHS Assistant Secretary for Preparedness and Response and holds a $7 billion inventory as well as vast experience in preparing for and responding to a variety of public health threats. Over time, the SNS has strengthened the federal government’s response capabilities so that the country is more prepared than ever to help protect the health and safety of the American people.
For the last two decades, experts at the SNS have worked to stockpile lifesaving products and build partnerships so we are ready to respond when disaster strikes. As a result, today’s SNS has the capacity to get the right medicines, supplies and devices to the right people at the right time.
One of our first collaborative efforts was working with the New York City Department of Emergency Operations responsible for medical countermeasure planning and the Federal Aviation Administration. On Sept. 11, 2001, one month after the three organizations staged their first full-scale exercise, an early morning attack on the World Trade Center and the Pentagon shocked the nation and the world. The stockpile was called into action as part of the government’s immediate response to the deadliest terrorist attack on U.S. soil and delivered medicines and supplies within 12 hours of the request.
On the heels of that incident came the 2001 anthrax attacks, which served as a wake-up call for the United States and the western world on the realities of bioterrorism. Scientists in laboratories and doctors in hospitals became acutely aware of the dangers of bioterrorism and voiced concern about their ability to identify such illnesses and treat patients to save lives.
Identification of bioterrorism-related diseases is not as straightforward as one might think. Illnesses caused by bioterrorism often mimic the symptoms of other, more common maladies. In the wake of the anthrax attacks, treatment options were extremely limited. In addition, even after a healthcare provider identifies a cause, treatment is not always readily available. For twenty years, we have worked with our public and private partners to expand the treatment options that are stockpiled in the SNS and to build the partnerships and protocols to respond on a moment’s notice.
The crises of 2001 led to a cultural shift in how public health, emergency management, and medical experts think about national security. These potential threats resulted in public health becoming an important component in the national security framework and changed the way state and local health departments worked and interacted with other agencies and sectors. Health departments became accepted as important partners by traditional emergency management and first responders, including law enforcement, fire departments and emergency medical services. The nation’s ability to respond to disasters strengthened with each area of government working together.
Since 1999, the stockpile responded to more than 60 public health emergencies, including natural disasters and disease outbreaks with the potential to threaten public health. The SNS deployed medicines, supplies, equipment and expertise for multiple major natural disasters, including Hurricanes Katrina, Sandy, Harvey and Maria, as well as flooding in North Dakota. When the SNS responds to an emergency, it fills major gaps, providing medicines, medical supplies, equipment, personnel and more.
The SNS also has deployed medical countermeasures rapidly and efficiently in the wake of disease outbreaks. During the 2009 H1N1 influenza pandemic, the SNS demonstrated its ability to deploy antiviral drugs and personal protective equipment nationwide for an influenza emergency. The SNS shipped 25 percent of its total supply of influenza antiviral medications to 62 areas in just 7 days.
In emergencies, the SNS works with public and private sector partners to find and close gaps. For example, during the 2014 Ebola response, the SNS coordinated with supply chain partners to identify gaps in the commercial supply of personal protective equipment (PPE) to healthcare facilities. Requests for PPE in hospitals were prioritized, and the SNS established a small supply of Ebola-specific PPE to better prepare for future outbreaks.
Emergencies can overwhelm state and local medical resources even with the best preparation. To help in those situations, the SNS has evolved to become the nation’s largest supply of life-saving pharmaceuticals and medical supplies for use in a public health emergency. Staff at the SNS are honored to serve our country in this unique capacity.
Whether you work for a hospital, a healthcare facility, or public health department, learning about the SNS can help you enhance your organization’s preparedness and national health security. Discover our in-person and online training opportunities to increase your understanding of the assets available from the SNS and teach you how to receive, stage, and use the products during emergencies, and more. For more information, see the Strategic National Stockpile Course Listing.
Outpatient care settings - including federally qualified health centers (FQHCs), rural health clinics (RHCs), urgent care centers, home health and hospice agencies, and primary care provider practices - have a wide range of capabilities that could be used to save lives in an emergency, but are they integrated into our nation’s emergency healthcare response system? How can healthcare coalitions better engage outpatient healthcare providers to enhance disaster response?
These are just some of the questions the experts from ASPR’s Technical Resources, Assistance Center, and Information Exchange (TRACIE) asked as they worked to better understand medical surge preparedness in outpatient settings. Their findings have important implications for healthcare system preparedness and healthcare coalitions.
Starting in 2017, ASPR TRACIE began working with experts from health clinics, urgent care centers, home health and hospice agencies, and primary care associations to learn more about their perceived roles in their healthcare coalitions. ASPR TRACIE experts found that, regardless of the healthcare setting, most participants knew they had a role to play in community emergency preparedness and response efforts; they managed many important assets, and many of them have tested their disaster response protocols, although gaps remain due in part to lack of resources. In many cases, the key to better integration of these outpatient providers into the nation’s healthcare system is to ask them to participate.
Outpatient care settings have critical assets they can use to bolster community preparedness and resilience; treat lower acuity injuries and illnesses to keep patients out of or help decompress hospital emergency departments during surge responses; and provide follow-up care and monitoring during the disaster recovery phase.
Although outpatient care settings have many resources that could be used to save lives in an emergency, ASPR TRACIE found that wide variation exists in the capacity and resources of each healthcare setting; and their potential role in responding to a medical surge incident has not been clearly defined in most communities.
Most outpatient care providers have tested their disaster response protocols and procedures, and many have started implementing business continuity strategies to enable sustained care of existing patients and potential care of new patients whose traditional care settings may have been disrupted by an emergency. However, experts from all outpatient healthcare settings indicated that a lack of time and resources to participate in training was a major barrier to better preparedness.
Among those less engaged in emergency management activities, the greatest motivator to participation is being asked. In some cases, “being asked” equates to patients seeking care during a disaster. Other times, participation is a result of a request from a Healthcare Coalition (HCC), a healthcare system partner, or a local, state, or federal public health or emergency management agency.
Engaging outpatient care providers before a disaster strikes can help ensure that you are working together to save lives when disaster strikes. ASPR TRACIE identified seven actions to improve the readiness of these healthcare settings for emergencies and disasters:
To learn more about the capabilities of outpatient healthcare providers and ways that you can engage them and become ready to work together to enhance medical surge capacity when disaster strikes, check out ASPR TRACIE’s Engaging Healthcare System Partners in Medical Surge resource page.
Project BioShield is revolutionizing the way we protect Americans from 21st century health security threats. Think back almost 18 years ago to the anthrax attacks of 2001. That crisis highlighted just how few medical countermeasures our nation had to respond to a bioterrorism incident. The anthrax attacks taught us important lessons that still guide our thinking: innovation is critical, partnerships matter, and the threats that we face are very real and very serious.
Although we have developed medical countermeasures to address some of the injuries and illnesses caused by many the most pressing national health security threats, challenges remain. Some of the injuries or illnesses remain as risks; some threats and their impacts remain unknown.
Since 2001, our understanding of the threat space has evolved and we have worked with our partners across government, notably within the Department of Homeland Security, to better understand the threats our nation faces. Improving the available medical countermeasures to address 21st century health security threats is a national security imperative.
As directed in the
National Biodefense Strategy, we are continuing to enhance preparedness to ensure health security and save lives. We are expanding our portfolio of medical countermeasures to address the remaining threats and to counter new and unknown threats.
We are better prepared today than we were 15 years ago because of sound investments in biodefense made using Project BioShield, strong partnerships, and a shared commitment to cutting-edge innovation. Project BioShield is our commitment to accelerate product development and ensure availability of those products for Americans.
The anthrax attacks of 2001 brought our needs into sharp focus: we didn’t just need a vaccine. To save lives in a future bioterrorism attack, the nation needed an array of medical countermeasures, including diagnostic tests to inform triage and treatment; post-exposure vaccine to provide quick protection against infection; antitoxins to counteract the toxic effects of the bacteria; and next-generation antibiotics. Today, BARDA supports a
broad array of medical countermeasures not just against anthrax but also to combat the health effects of other chemical, biological, radiological, and nuclear threats.
Developing novel medical products can require decades and billions of dollars in the private sector, and the same is true of medical products needed for national security. As a nation, we have accomplished much in a relatively short time due to strong and long lasting public-private partnerships. Project BioShield isn’t just a funding mechanism; BARDA also provides technical expertise and resources. We have a network of organizations to assist product developers with non-clinical and clinical studies. We have a network of companies that provide formulation and fill-finish manufacturing services to get vaccines and other products into vials or syringes for ease of use in communities during crises. And our expert staff may be our greatest resource of all, providing technical recommendations based on decades of experience.
BARDA also uses unique authorities provided to us to forge partnerships with companies to develop entire portfolios of products. Using this portfolio approach, each company works with BARDA to decide which products move in and out of their joint development portfolio to serve commercial and national emergency needs. Our expectation is that products advance to be supported under Project BioShield to save lives in emergencies.
To invest public funds wisely, BARDA focuses on products that have commercial market potential as well as emergency uses whenever possible. We look for partners on development portfolios, and look for solutions to some of our nation’s most daunting health security challenges. The future for Project BioShield is to broaden our commitment to Americans to be ready in America’s darkest hour. With Project BioShield and our partners, we can decrease the negative health consequences from health security threats and save lives.
Antimicrobial resistance (AMR) is an increasingly serious threat to America’s public health and national security. The resources necessary to discover, develop and commercialize innovative, life-saving antimicrobials are similar to other disease areas; however, the relative return on investment is exceedingly low.
In May, I highlighted the need for an immediate paradigm shift in the antimicrobials marketplace. I specifically called out the importance of building new business models, developing novel partnerships, focusing on market strengthening strategies, and ensuring BARDA’s leadership in this effort. One such novel and exciting partnership for BARDA is that with the Centers for Medicare & Medicaid Services (CMS).
Without payment reform, the antimicrobials marketplace will not survive. CMS Administrator Seema Verma understands this reality and the necessity for a strong marketplace for both public health and national security purposes. On Friday, August 2, CMS issued its fiscal year (FY) 2020 Hospital Inpatient Prospective Payment System (IPPS) Final Rule. Among other changes to the way CMS pays for Medicare services, CMS recognized the need for greater payment of newer, potentially safer and more effective antimicrobial drugs.
The new rule will (1) change the severity level designation for multiple ICD-10 codes for antimicrobial drug resistance from ‘non-CC’ to ‘CC’ (which stands for complications or comorbidities) to increase payments to hospitals due to the added clinical complexity of treating patients with drug-resistant infections, (2) create an alternative pathway for the new technology add-on payment (NTAP) for qualified infectious disease products (QIDPs), under which these drugs would not have to meet the substantial clinical improvement criterion, and (3) increase the NTAP for QIDPs from 50 percent to 75 percent.
This final rule lessens economic incentives to utilize older antimicrobial drugs such as colistin, and shift medical practice to employ more appropriate, newer generation antimicrobials. Payment more closely aligned with the value of these lifesaving medicines will shift the current market realities of these drugs for companies, investors, and patients.
No single action will solve the antimicrobial resistance problem; however CMS’ efforts undoubtedly can improve the marketplace and re-catalyze innovation in basic science discovery, and research and development efforts. We appreciate and congratulate Administrator Verma for taking such bold leadership in this fight.
At BARDA, we will continue to lead efforts in the fight against antimicrobial resistance by building new relationships, new partnerships and new models. In partnership with HHS divisions, BARDA is seeking to re-catalyze investment into antimicrobial companies by supporting reimbursement reforms and creating market strengthening initiatives that increase forecasted peak sales of these antimicrobial drugs to a level where companies can become self-sustaining.
BARDA is exploring a four-pronged strategy which requires collaboration and action across HHS and potentially includes: (1) building upon these CMS reimbursement reforms, (2) commercial marketplace strengthening, (3) securing US-based infrastructure of medical countermeasure development, and (4) developing a clinical trial network to conduct the most challenging and medically important clinical studies for serious life-threatening infections.
We are proud to have collaborated with CMS on this effort, and we look forward to working with our partners – new and old – to save lives from antimicrobial resistant threats.
Project BioShield has revolutionized the way we protect Americans from 21st century health security threats. Our ultimate goal is to save lives during a national disaster; we prepare for this eventuality by pursuing FDA approval and availability of countermeasures in preparation for such emergencies. The government alone cannot fill the need for medical products to save lives in public health emergencies and disasters; public-private partnerships are essential every step of the way.
BARDA’s approach to public-private partnerships is remarkable. We reduce business risk, we provide non-dilutive cost-sharing, and we offer technical expertise from our deeply experienced staff within BARDA. We partner with pharmaceutical and biotech companies across the spectrum, from some of the world’s largest companies to small, promising startups. Together, we’re seeing record success in developing products under Project BioShield that otherwise wouldn’t exist.
Project BioShield isn’t just a funding mechanism; it’s a commitment to Americans and a commitment to our industry partners. Moving a medical countermeasure from a good idea to an FDA approved product takes a strong commitment in time, expertise, and long-term investment. Yet in implementing the Project BioShield Act, we discovered another gap: a lack of products in research and development that were advanced enough to become candidates for late-stage development and purchase through Project BioShield.
Over the last 15 years, BARDA has leveraged unique partnerships, funding, strong technical expertise and interagency coordination to strengthen the medical countermeasure pipeline so products reach late-stage development support and, ultimately, become available to protect Americans and save lives.
Many of the projects currently funded under Project BioShield received BARDA support for their advanced research and development. In 2006, the Pandemic and All-Hazards Preparedness Act authorized BARDA to “accelerate countermeasure and product advanced research and development”. Today, BARDA awards advanced research and development funds based on proposals submitted under our rolling BARDA Broad Agency Announcement (BARDA BAA).
Under the BARDA BAA, companies, large or small, can apply for advanced research and development funding for vaccines, therapeutics, diagnostics, and devices to address chemical, biological, radiological, and nuclear threats; pandemic influenza; and emerging infectious diseases – a total of 17 areas of interest. Once these products mature, some may be supported by Project BioShield, subject to the availability of funds and national health security needs. Some products also may be supported by the private sector for common medical needs in the commercial market.
We know antimicrobial resistance poses not just a public health threat but also a national security threat, either because the infections caused by biothreat agents could be resistant to antibiotics or because antibiotic resistant infections develop in people exposed to many threats, regardless of their nature. In 2010, we recognized research and development of new antibiotics had collapsed in the private sector and that no products to combat this threat were advanced enough for Project BioShield.
To help stimulate the industry and revitalize the pipeline, BARDA began supporting development of novel antibiotics – three of which are now FDA approved – to combat antimicrobial resistant infections and biothreats, and co-sponsored the world’s largest public-private partnership to combat antibiotic resistance: CARB-X.
Today, CARB-X supports nearly 30 products in its portfolio, and CARB-X partners continue to fund new, innovative technology and products to combat antibiotic resistance. In the process, CARB-X partners are revitalizing the early stage antibiotic pipeline, which strengthens the pool of potential candidates from which NIAID’s early R&D and BARDA’s advanced R&D programs may select. From there, these products could become candidates for Project BioShield funding. Development also can be completed by private companies. This year, due to progress made under advanced research and development, BARDA released the first request for proposals under Project BioShield for antibiotics to combat biothreats.
Some of the products BARDA has supported under Project BioShield transitioned to BARDA after companies had collaborated with the Department of Defense or the National Institutes of Health on early phases of research and development. This multi-agency pipeline approach began with a smallpox vaccine, available now only because of two decades of federal support and industry collaboration.
The vaccine transitioned from discovery and early development with support from DoD and NIH to advanced development support from BARDA with late-stage development under Project BioShield. This smallpox vaccine is not only part of our national health security but also part of the U.S. commitment to develop vaccines and treatments against smallpox infections to protect global health security.
BARDA continues to work with its partners throughout the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) to ensure smooth transitions between federal agencies involved in medical countermeasure development. The PHEMCE Multiyear Budget details the funding priorities for the near-, mid-, and long-term.
Under the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA). PAHPAIA, Congress reauthorized Project BioShield’s Special Reserve Fund and authorized 10-year funding for product development.
With such strong federal commitment, the Project BioShield portfolio continues to grow and evolve. We will continue to forge strong partnerships to develop next-generation medical countermeasures in response the ever-changing threats to biosecurity. If your company is interested in partnering with BARDA on medical countermeasures to strengthen health security, join us for a TechWatch meeting to discuss your product ideas and check out our broad agency announcement.
When Project BioShield was signed into law 15 years ago, the nation had few medical countermeasures to rely on in national emergencies. In the interceding years, BARDA has worked with its partners throughout government and industry to find creative solutions to address health security threats. Together, we have developed safe and effective medical countermeasures to protect the public in emergencies.
BARDA has supported 27 projects using Project BioShield authorities and funding. We’ve added 15 products to the Strategic National Stockpile. We’ve worked with industry partners to achieve FDA approval of 10 of those products and to make the others available under Emergency Use Authorization from the FDA. In 15 years, that’s unprecedented!
The commitment of Project BioShield shows what government and private industry can do for the American people when we work together. We’ve developed a broad portfolio of medical countermeasures to address such diverse threats as Ebola, anthrax, botulism, smallpox, nerve agents, radiation, thermal and radiation burns.
Some of the medical countermeasures supported under Project BioShield are being used to enhance global health security by addressing the ongoing Ebola Virus Disease outbreak in the Democratic Republic of Congo. Secretary of Health and Human Services Alex Azar recently described the current Ebola outbreak as one of the department’s top global health priorities. He cautioned the current Ebola outbreak is unlikely to be the last and noted that investing in vaccines today either will help defeat this outbreak or be vital to beginning the response to the next one.
BARDA is supporting late-stage development of two Ebola vaccines with the goal of vaccine licensure. One of these vaccines is being used as part of a voluntary ring-vaccination campaign to help protect more than 162,000 people in the current outbreak. In addition, two Ebola therapeutics being supported under Project BioShield are being used as part of an ongoing randomized clinical trial in the Democratic Republic of Congo.
We also are using Project BioShield funds to develop medical countermeasures that address burns and blast trauma, two potentially deadly consequences of nuclear incidents. Almost half a million people in the U.S. suffer from burn injuries every year leading to about 40,000 hospitalizations. The products being developed under Project BioShield will address the medical needs and treatment challenges associated with burns to improve the quality of care every day and in disasters.
By developing products we need for emergency response and leveraging their daily use in the commercial market, we reduce the tax payers’ cost of development and of stockpiling and stimulate an important financial return on investment for private partners. In addition, healthcare providers become familiar with how to use the products so they’re comfortable using them in national emergencies.
With recent legislation and new initiatives, we’re poised to build on that success for years to come. The commitment to preparedness has to be continuous and, because of Project BioShield, the U.S. healthcare system is increasingly prepared to respond to disasters and save lives. That’s the most important return on investment.
Teams that perform well have a shared mental model of success. Think about penguins. In the waters of Antarctica, penguins form groups to perform a complex task: get food in a chaotic environment with competing demands. But, all of these penguins are operating with a shared idea of success: fish for dinner (or breakfast, or lunch…). Healthcare coalitions often don’t have that level of clarity and that can be a real problem. When their teams come together, they often don’t agree on the goal. According to experts from the Naval Training Systems Center, teams that perform well have shared mental models. Put more simply, it is more likely that your team will achieve a goal if you all understand what the real goal is.
The Health Care Coalition Response Leadership course helps healthcare coalition members achieve that shared sense of purpose and start thinking about their real goals: saving lives, decreasing morbidity, and continuing to care for people in the face of disaster. The course helps move people away from thinking about their coalition in terms of just administering the grant or finding their place on an org chart and toward the core purpose of the coalition.
The Health Care Coalition Response Leadership course brings together core members from different disciplines to redefine the way they think about disaster preparedness. The course, which was developed by HHS/ASPR’s
Hospital Preparedness Program (HPP) and FEMA’s
Center for Domestic Preparedness, gives attendees a chance to build relationships and get practical experience to help them better prepare for disasters and emergencies.
Together, HPP and FEMA developed the course and teach it at the Center for Domestic Preparedness in Anniston, AL. The course includes classroom instruction, practical experience, and best practices for responding to disasters as a health care coalition leadership team.
Each coalition brings two leaders from each of their core members:
EMS, public health, and
emergency management. They bring a ninth participant from any discipline. At least one of the one person must be a nurse or physician.
To create the best learning experience, HPP carefully selects the three coalitions that participate in each class. While you probably know the people in your own coalition, you don’t know the people from the other two coalitions until you walk in the door.
To begin the class a representative from each coalition does their “Meet Our Coalition” presentation. Participants from the other two coalitions fire off questions. To their surprise, participants uncover some common – and some very different – experiences.
Reactions to the “Meet Our Coalition” presentations come quickly. “What communication system do you use?” “You really have an EOC?” “How did you evacuate so many hospitals?” “Our first time with the Coalition Stress Test was hard too, but we learned so much.” “How did you do that purchasing agreement with your supplier?” “What patient tracking system do you use?”
The coalitions’ different organizational structures, types of disaster responses, geographies, and populations make for lively class discussions.
The only schedule we HAVE to keep to is getting you to lunch and to the bus on time. Instructors know this class is different. Yes, the course has a schedule. Yes, there are PowerPoint presentations. But, letting participants and coalitions learn from each other is far more valuable than keeping to a strict schedule or making sure every point on a slide is covered.
Instructors patiently facilitate and let intense conversation go on for critical topics like: how and when to activate as a coalition, what it means for a coalition to “respond,” the impact of the CMS rule, succession planning, and active shooters. The conversations lead to new possibilities and solutions.
Exercises are the most important part of the course. At the beginning, six hospital representatives, two from each coalition, go to a flip pad in one corner. Representatives from EMS, public health, and emergency management each go to a separate corner and start writing on flip pads. After each discipline presents its priorities for the scenario, it’s common to hear, “I thought it was just Mary from EMS in our coalition who came up with those EMS priorities all the time. Seems like everyone in EMS has the same priorities!” Participants quickly learn the cultural differences among the disciplines in their coalition make them stronger.
Each coalition works as a team on exercises too. Participants learn about ways that they can contribute to a response, including information sharing, situational awareness, resource sharing, and policy development.
No surprise here … the exercises get tougher as the class progresses. There’s the Electro-Rave Festival mini exercise, a weather-related exercise, and (of course!) there’s an infectious disease exercise. During the intense problem solving sessions, the coalitions’ participants learn more about each other and how they each have extraordinary skills, resources, and talents. They don’t really know how much they have together until they come to Anniston.
The last class assignment is for each coalition is to meet and decide on three to five goals they plan to achieve within six months. They also develop a vision of what their coalition will be in three years. Each coalition reports out their plans and vision.
Coalitions grow faster than the speed of light in Anniston – it is really amazing. The Health Care Coalition Response Leadership course participants make new friends with members of the other coalitions. They tend to stay in contact and share their knowledge and experience. They have discovered their own coalition’s participants are far more knowledgeable, resourceful, and committed than they imagined. They will rely on each other with a new sense of purpose. Yes, the sum of their parts is greater than the whole. Five days of commitment in Anniston. Five days that have made their coalition’s response to disasters much stronger.
Interested in applying for the Health Care Coalition Response Leadership Course?
Download the application and start forming your team today!
Saving lives in a public health emergency requires cutting-edge medical countermeasures: medications, vaccines, diagnostics, and more. In some types of emergencies, like an act of bioterrorism, some of those medical products have no commercial market. People don’t use an anthrax antitoxin every day – thank goodness. Yet that lack of commercial market also means pharmaceutical or biotech companies had only one possible buyer for their products: the federal government for stockpiling.
In 2004, Congress passed the Project BioShield Act to create a market for products necessary for disaster response but with limited or no commercial market. The Act provides HHS with a multi-year special reserve fund to support late-stage development and manufacturing, and the financial resources to buy these life-saving medical products for the American people to use in public health emergencies. In this way, Project BioShield is a critical part of the U.S. strategy for biodefense and our commitment to the American people.
Last month, Congress took action to further strengthen Project BioShield as part of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA). PAHPAIA increases the budget authorization and provides ten-year funding for product development. We know next-generation medical countermeasures aren’t developed overnight – in fact, getting a product across the finish line takes many years. Multi-year funding helps BARDA continue building the strong public-private partnerships needed to spur innovation and provide the private sector with the stability needed to produce potentially lifesaving medical countermeasures.
For example, smallpox is one of the most consequential infectious diseases in human history, responsible for nearly 300 million deaths in the 20th century alone. It is also a high-priority threat requiring federal agencies to develop strategies and countermeasures against this threat. Thanks to our partners at NIAID and DoD and the support of Project BioShield, last year our industry partner was issued an FDA approval for a treatment for smallpox via the animal rule. At present, there are now over 2 million treatment courses in ASPR’s Strategic National Stockpile to protect Americans in the event of a smallpox national security emergency.
However, we have found over the past 15 years the most practical and cost-effective approach is, whenever possible, to look at products that not only can be used for emergencies, but also have uses in daily medical care, such as burn care, the radiation effects cancer patients encounter, or seizures.
In some cases, we’ve worked with companies to expand indications for existing products. For example, three medical countermeasures are now FDA-approved to treat patients suffering bone marrow and blood cell damage from acute radiation syndrome. All three of these products were already licensed drugs used to treat patients undergoing radiation therapy for cancer. Project BioShield funding was used to conduct the critical studies needed to expand the indications for these products so they could also be used to treat the damage caused by acute radiation syndrome in a radiation emergency. Using such drugs is helpful in emergencies because healthcare facilities already stock the drugs, and clinicians are already familiar with using them.
We are using Project BioShield to support other new products with commercial market potential. For example, we supported a large study of a seizure treatment because seizures are one of the potentially deadly effects of nerve agents. The product is used commonly in preparing patients for surgery and for epileptic seizures; thanks to Project BioShield, the product is now approved as an antiseizure medication for status epilepticus and has been added to the Strategic National Stockpile for use in a chemical emergency response.
For 15 years, BARDA has been proud to partner with industry to develop cutting-edge medical countermeasures. Our country is better prepared to respond to health security threats because of Project BioShield. We look forward continued collaboration as we work to develop and produce medical countermeasures that can be used to save lives in the event of an emergency.
Last month, teams of volunteers from Medical Reserve Corps (MRC) units across the country taught life-saving skills to the people in their communities as part of Stop the Bleed month. The MRC is a national network of local groups of volunteers engaging local communities to strengthen public health, reduce vulnerability, build resilience, and improve preparedness, response and recovery capabilities. These volunteers dedicated more than 780 hours to training people in their communities – and MRC units are just one of many training providers. There are thousands of registered Stop the Bleed instructors worldwide, including physicians, nurses, law enforcement officers, and paramedics, to name a few.
But what is
Stop the Bleed and why is it an important public health tool? Because it teaches skills that save lives – and training is easier than you might think.
A person can die from blood loss in just five minutes. However, the average length of time from a call for help to the arrival of emergency medical services (EMS) personnel on scene is about
eight minutes. Wait times in rural areas are even longer, averaging about
14 minutes. So, if a person is bleeding heavily, there is a very real chance that they can die from blood loss before EMS arrives – unless a bystander takes action.
Bystanders are almost always the first people on the scene, but they might not know how to help and, without appropriate training, they may be unwilling to try. According to a
national survey on bleeding control, about half of respondents with no training indicated that they would try to help a person with severe bleeding. But about three out of four people who have been trained to control severe bleeding have indicated they are willing to help. By bringing this training program to people in your community, you can help give people the skills they need to save a life. Bystanders don’t have to stand by – they can save lives as immediate responders.
Stop the Bleed training teaches people life-saving skills and helps them understand when to use them. The training focuses on three main skills to limit blood loss: apply pressure to the wound with your hands, apply dressing and press, and apply a tourniquet. The training also teaches participants how to recognize life-threatening situations so they know when to apply a tourniquet and when to simply bandage the wound. You can also learn what to keep in your first aid kit so you are ready to help if needed. The materials are easy to understand and the class only takes about an hour.
However, Stop the Bleed training doesn’t have to take place in a classroom. Medical Reserve Corps volunteers have also staffed booths at community fairs to raise awareness of the program and teach the basics of bleeding control.
If you are interested in joining a Medical Reserve Corps unit in your community,
find a unit in your area and reach out to the team for more information. MRC units and their volunteers help their communities improve local emergency response capabilities, reduce vulnerabilities, and build community preparedness and resilience.
At ASPR, we’re excited about the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA), which the president signed last night. The new law strengthens public health and healthcare readiness, bolsters response and recovery programs, and increases transparency. What do the changes mean for our non-federal partners? We see some key provisions that can significantly improve preparedness and response for our partners.
PAHPAIA authorized a funding increase for the Hospital Preparedness Program from $374.4 million to $385 million which would continue to pass through state and territory health departments to healthcare coalitions. Congress must appropriate specific funding levels as part of the annual appropriations process, including any increase.
ASPR, the Director of National Intelligence, and the Department of Homeland Security are directed to coordinate regularly on threat assessments, including potential emergency health security threats. By coordinating more closely, ASPR will have the critical information to guide decisions about which medical countermeasures should take priority in development and acquisition for the Strategic National Stockpile and the National Pre-Pandemic Influenza Vaccine Stockpile.
The law reauthorizes the authority giving states and territories the ability to reassign federally funded personnel temporarily in public health emergencies to support the response. When the HHS Secretary declares a public health emergency, states may request temporarily deployment of state personnel whose salaries are funded by HHS in whole or in part under Public Health Service Act programs. Under PAHPAIA, the National Disaster Medical System (NDMS) received direct hire authority which streamlines the federal hiring process for NDMS, making it easier and faster to hire new personnel. The law also authorizes benefits under the Public Safety Officers Benefit program for NDMS personnel which addresses a concern of NDMS personnel. NDMS personnel have jobs in the private sector and are called into federal service during disasters, and these provisions are expected to improve NDMS recruitment, which in turn increases the number of NDMS personnel available to support state and local healthcare emergency operations.
The Hospital Preparedness Program received enhanced authority under the reauthorized law. Coalitions funded under this program now can use the funding for response activities, and work with state health departments and other healthcare coalition members on greater accountability; with the new authorization, ASPR has two years to work with grantees and sub-grantees on coalition success rates; ASPR now could withhold a percentage of program funds from awardees that fail to meet required benchmarks.
PAHPAIA also authorizes ASPR to establish guidelines for the Regional Disaster Health Response System. Under the provisions, ASPR is authorized to use HPP funds to support demonstration projects related to the development and implementation of these guidelines. The Government Accountability Office is required to assess the program within three years and provide Congress with specific findings on success, limitations, and challenges.
Project BioShield received an increase in its authorized funding levels with appropriations authorized for 10-years. This longer timeframe means Congress can provide funding for a decade rather than on an annual basis. Given that a single medical product can take 10 years or longer to develop, long-term funding like this gives biotech and pharmaceutical companies an incentive to work with our Biomedical Advanced Research and Development Authority (BARDA) on advanced development, manufacturing and acquisition of medical countermeasures.
Programs to develop medical countermeasures for pandemic influenza and other emerging infectious diseases now are authorized to receive annual funding from Congress. In the past, funding to develop medical countermeasures for pandemic influenza and emerging infectious diseases came largely from supplemental appropriations after public health emergencies occurred, such as the H5N1 pandemic in 2009 and the Ebola responses in 2014. Having a standard budget line allows federal and private partners to undertake research, development and manufacturing before a disease spreads. Not waiting having to wait on supplemental budget funding is important because developing medical products takes years and to save lives in public health emergencies every moment counts.
These are exciting changes, and we look forward to working with our partners under the new and reauthorized authorities to protect the American people from modern health threats.