At BARDA, we are proud to have established unique partnerships with industry that create solutions for the American people. By working together, we have earned – as of last week – our 50th and 51st U.S. Food and Drug Administration (FDA) approvals, licensures and clearances in the past 12 years for products that address some of our nation’s most challenging health security threats. BARDA and our private sector partners achieved eight of these in the past year alone, substantially increasing the nation’s health security preparedness.
From our first, a pandemic influenza vaccine licensed in 2007, to last week’s clearance of the first anthrax diagnostic test that could be used in non-government labs in a surge capacity, we have tackled hefty scientific and business challenges.
Many health security threats involve bacteria or chemicals for which clinical trials cannot be performed in humans. To overcome this hurdle, we worked closely with FDA on a path for approval of such products using the Animal Rule. Raxibacumab, a treatment for anthrax, became the nation’s first medical countermeasure to utilize this path, earning FDA approval in 2012. Since Raxibacumab was approved, our partnerships have resulted in five additional approvals using the Animal Rule, including three products that can be used to treat white blood cell depletion that occurs after a radiological or nuclear event. Even as we utilize this pathway, we continue to explore new technologies that could pave a more efficient path to approval.
Another hurdle has been the return on investment for the private sector and taxpayers. To overcome this challenge, we have reduced the business risk and costs not just by providing non-dilutive funding and deep technical assistance but also by focusing on products that could have multiple uses and commercial uses.
In some cases, we’ve sponsored development for new indications of approved products like Seizalam and Silverlon. Midazolam was an approved sedative and became the first approved as an anti-seizure drug to treat prolonged seizures caused by chemical exposure. Silverlon was cleared initially as a silver-impregnated wound dressing and became the first product cleared in the U.S. for use in treating chemical burns from mustard gas.
In other cases, we’ve sponsored development of products that meet needs in the commercial market and health security, such as for XERAVA (eravacycline), a novel, fully synthetic tetracycline antibiotic that was approved in 2018 to treat complicated intra-abdominal infections. The antibiotic also could be used against serious Gram-negative infections, including those caused by multi-drug resistant pathogens, and, with FDA Emergency Use Authorization, could be used to treat anthrax, plague, or tularemia.
Nineteen of our 51 approvals are vaccines, diagnostics, or treatments that increase our preparedness for influenza pandemics. The technologies that BARDA has supported to prevent, diagnose or treat pandemic influenza can also be used to combat the seasonal influenza epidemic.
We know the nation must be ready to face all health security threats – the ones known today, those emerging, and those not yet imagined. By partnering to create innovative countermeasures tailored to meet unique national security demands for rapid response, we become better prepared to act quickly to save lives.
Our preparedness to save lives requires end-to-end solutions – from rapidly recognizing the problem to treating patients quickly, safely, and effectively. Hence our focus on disruptive innovation to detect disease earlier; better, faster vaccine technologies that protect patients and healthcare providers; and host-directed therapeutics for more effective treatment.
Over the past 12 years, in our pursuit of transformative medical countermeasures that will protect the American people in public health emergencies, we have partnered with more than 300 companies, from micro and small businesses to global pharmaceutical corporations. We continue to build and strengthen these partnerships using every business tool at our disposal. We know that the right science and technology truly can transform how people understand and participate in the preservation of public health and health security, resulting in a world in which invention unlocks the power of the collective good to overcome potential threats.
We continue to welcome new partners who share our passion for disruptive innovation to enhance our nation’s health security. Learn more about what we are pursuing next through the BARDA Broad Agency Announcement and start a conversation with us by requesting a meeting.
Is your Medical Reserve Corps unit looking for a way to bolster community preparedness? You can start by providing community members with training that gives them skills they need to respond – and the confidence to use those newfound techniques. When an emergency or natural disaster happens, many people want to help – but they just don’t know what to do.
The good news is that many people can learn lifesaving skills in a couple of hours – no medical background needed.
Consider this: according to a
National Survey of the Public Regarding Bleeding Control, 77 percent of respondents who had been trained in severe bleeding control indicated they were “very likely to aid a car crash victim.” But just 51 percent of respondents with no training indicated that they would be very likely to help. Being knowledgeable, trained, and prepared for an emergency can help alleviate hesitation and fear when disaster strikes, which can, in turn, lead to a stronger bystander response.
The Medical Reserve Corps (MRC), a national network of volunteers who help make their communities stronger and healthier during disasters and every day, can play a critical role in helping to provide information and training to community members so they feel educated and empowered to act before, during, and after an emergency. From natural disasters to health-related incidents, individuals and communities that are informed and trained to respond are more inclined to act when needed, and often better able to withstand and recover from disasters – and help their neighbors do so, too.
Below are examples of eight programs that MRC units can incorporate into their volunteer training plans and community-based outreach programs to teach community members life-saving skills and enhance overall individual and community preparedness:
To assist MRC units in rolling out the above programming, the MRC Program Office within the Office of the Assistant Secretary for Preparedness and Response recently developed a
Training Community Members to Respond Guide. It includes more details about each program and available curricula and resources. Questions or suggested additions to the guide can be directed to
Day four of the annual professional meeting began like so many others: I had one more talk to give, and then a dash to the airport for the flight home. At lunchtime, I noticed a slight headache. By the time the session began mid-afternoon, the headache was worse. I bummed a couple of over-the-counter pain pills from a colleague (thank heavens for better prepared friends!), chugged a botle of water, and listened to the three talks that preceded mine.
I felt a bit lightheaded starting my presentation. About ten minutes in, I had a shaking chill. Not a big one, not one that caused me to stumble, but a chill nonetheless. The audience did not notice—it was a talk I had given before, I knew the words that needed to accompany each frame. The session wrapped, I had another bottle of water, and started the journey.
Twelve hours, several more chills, and a few more bottles of water later, I made it home. I was exhausted. I told my wife that I thought I might be getting the flu (despite having received the seasonal immunization) and just needed to catch up on rest. She said “fine, but please let your doctor know”. Yes, we doctors have doctors.
My doctor also happens to be my neighbor down the street. He decided to stop by the house—"just to have a quick look” at me. He said that I didn’t look too bad, rest was a good idea, but maybe it was also a good idea to go over to the hospital and get some lab work done. No, I didn’t have a fever—but then I had continued my diet of over-the-counter pain medications that also happened to be antipyretic. Besides, I wanted nothing more than some sleep.
I took my doctor’s advice, and upon arriving at the hospital my white blood count was reported to be two and half times the upper limit of normal. My kidney function was only about 40% of the expected value. While I was not jaundiced, the lab data showed that my liver was not processing bilirubin well. Oh, and by this time my left leg had swollen to twice normal size and turned bright red. In “doctor-speak”, the diagnosis was erysipelas—likely caused by group A streptococcus—and I easily met the Sepsis-3 vital organ dysfunction criteria.
Did I mention that my blood pressure had started to fall?
I was admitted to the hospital, blood cultures were taken, IV fluids were started. Within minutes, I received broad spectrum antibiotics. I don’t remember much more about that first day in the hospital, except having the presence of mind to decline transfer to the VIP pavilion—better to be around medical and nursing staff who would treat me just as they treated everyone else.
By the next day, I was much better. The initial antibiotics had accomplished their “expected miracle”, the spectrum had been narrowed to address the likely pathogen, and my vital organ functions were improved. Only then did I begin to appreciate just how sick I had been.
That’s how sepsis is. Sepsis shows up uninvited, arrives unannounced, and triggers deep fatigue–all the while scrambling your brain just enough to hide the fact that “a little rest” might presage “the big sleep”. I treat sepsis, I study sepsis, I write articles on sepsis—and I was sure that sepsis was something that happened to other people.
That was six months ago this week. Unfortunately, it’s more than a bad memory. Becoming a “sepsis survivor” is not the same as being completely cured: sepsis confers excess risk of all-cause mortality for at least several years. My particular infection carries some likelihood of recurrence. On the advice of my healthcare team, I now carry specific countermeasures with me whenever I travel along with an instruction to begin taking the drugs should I experience similar symptoms. I have acquired some persistent leg swelling that requires me to wear compression stockings on a daily basis, a constant reminder that I remain vulnerable.
I was invited to join BARDA DRIVe and the Solving Sepsis team for my sepsis subject matter expertise in August 2018. Yet it took a personal encounter with sepsis for me to understand that no matter who we are, where we are, and what we do, we are all vulnerable. The BARDA DRIVe Solving Sepsis program is accelerating the development of transformative technologies to address sepsis as well as working with government partners. As September is Sepsis Awareness Month, this is a reminder to us all to be aware of the signs of Sepsis.
If you, a family member, a friend or a colleague, think, “Could this be sepsis?”
Ask the question.
Seek prompt medical attention.
You might save a life.
The life you save might be your own.
As any emergency responder knows, EMS providers, healthcare professionals and other emergency responders work in fast-paced, demanding, challenging environments. Although this work can be incredibly rewarding, the accumulation of daily stressors coupled with the intense pressures associated with a disaster – such as taking on unfamiliar duties, witnessing horrific events, comforting traumatized people, working back-to-back shifts, eating poorly, and sleeping rarely – can have serious repercussions for responder behavioral health.
According to research by the
Substance and Mental Health Services Administration, about one in three emergency responders suffers from post-traumatic stress disorder or depression. In addition, responders and staff in emergency response agencies are at an increased risk over the long term for experiencing compassion fatigue and burnout.
At an individual level, behavioral health problems can be hard to recognize and address. At an organizational level, they can seriously hinder your emergency management organization or healthcare facility’s ability to respond effectively.
So how can you recognize when someone needs help and what can you do to help them? Start by learning some core concepts, warning signs, and ways to help.
Burnout, compassion fatigue, and PTSD are sometimes used almost interchangeably but they actually describe different conditions, each with its own specific symptoms, although these can overlap. Being able to understand the causes of each condition can help you recognize a problem and identify some strategies that could help you or members of your team.
Day-to-day work-related stress, which are often intensified during a disaster or emergency
Over-identifying with or taking on the trauma and emotional distress of others
What Causes It? A frightening or highly distressing event that results in symptoms of re-experiencing,avoidance, arousal, and changes in mood or thinking
Serving as an emergency responder is stressful at any time, but disasters can quickly compound stress. For many responders, disasters lead to longer hours or shift work; require people to work with insufficient resources; increase the chance of interpersonal conflict with colleagues, patients, and others; and disagreement about the most effective way to execute the mission.
Burnout can have serious consequences. Individuals who are experiencing burnout may feel helpless or like they can’t control their environments. These feelings can lead to poor job performance, a bad attitude, or strained relationships at home and at work.
If you see these signs, take steps to keep the problem from getting worse. Sometimes, simple things can help someone who is suffering from burnout bounce back.
The emotional demands on emergency responders during a disaster can be constant. Although empathizing with the people that you are helping is important, over-identifying with patients and family members can lead to compassion fatigue, also known as secondary traumatization.
People who suffer from compassion fatigue tend towards emotional extremes: they may be numbed to the suffering of others or they may be over-engaged and find it hard to “unplug” from their work. To complicate matters, people who experience compassion fatigue often don’t realize that they are struggling.
Like burnout, compassion fatigue can be serious if it is left unaddressed. Responders who suffer from compassion fatigue are more likely to become depressed and are more prone to substance abuse and social isolation.
But there are things that you can do if you recognize compassion fatigue.
During a disaster, emergency responders frequently have to work through frightening events that may be traumatizing. Emergency responders have been called on to pull people out of the World Trade Center, treated children with gunshot wounds after school shootings, or witness the severe injury or even death of a colleague. After a traumatic event, people with PTSD may find themselves reliving the event and they may become agitated, hostile, hyper-vigilant, or self-destructive. People suffering from PTSD may isolate themselves from others, making it harder to identify the problem. Further compounding the issue, first responders often work in organizations or environments that downplay the importance of seeking help with managing stress and distress.
PTSD is both serious and treatable. It often requires professional intervention and guidance along with organizational support that recognizes the value of seeking help. If you think you are suffering from PTSD, get help. Start by getting an physical and mental health assessment, as effective treatment often relies on a combination of approaches. If you think that someone you work with may be suffering from PTSD, encourage them to seek help.
Getting professional help is critical. Here are some other steps you can take in addition to seeing professional help.
The road to recovery form PTSD can be long, but people do recover. If you are diagnosed with PTSD, stick with your treatment and commit time and energy to recovery. If someone you know is recovering from PTSD, support them throughout the recovery process.
During September, people and organizations take some time out to think about preparing for disaster. Preparing for the behavioral health impacts of a disaster is an important part of individual and organizational preparedness. Before a disaster strikes, learn about steps you and your organization can take to prevent burnout and compassion fatigue, decrease stress, promote wellness, and encourage self-care.
Disaster Behavioral Health Self Care for Healthcare Workers Modules, a new series of in-depth video modules from ASPR TRACIE, provide information for front line healthcare and social service workers to use before a disaster strikes so they are better able to recognize signs of burnout and compassion fatigue and take steps to mitigate them. To learn more about PTSD, visit the
National Center for Posttraumatic Stress Disorder. For a more in-depth list of resources, see the
ASPR TRACIE Responder Safety and Health Topic Collection.
Hurricane Dorian didn’t deliver the damage, destruction, and mass patient caseload to Puerto Rico and the U.S. Virgin Islands that many people anticipated the storm would — and that’s a good thing. Nevertheless, Puerto Rico was ready for a hurricane in a way it has never been before thanks to the efforts by HHS’ Division of Recovery team.
Over the past two years, federal and territory government agencies and non-government organizations have worked together to prepare Puerto Rico and the U.S. Virgin Islands healthcare systems for hurricanes and other natural disasters. These U.S. territories are still recovering from Hurricanes Irma and Maria, which devastated the islands in 2017, and a direct hit from Dorian could have undone much of the hard work done over the last two years.
For example, the ASPR Division of Recovery worked diligently with the Puerto Rico Department of Health to facilitate regionalized networks of hospitals, primary care facilities, dialysis centers, emergency medical services, and emergency management. These networks have greatly advanced the situational awareness, logistics, plans, supplies, and other response mechanisms across the island.
Dr. Elaine Kolodziej, from Centro de Medico, thanks HHS staff for preparedness efforts in Puerto Rico.
Through these networks — a healthcare coalition — hospitals, federally qualified health centers, clinics, and other key healthcare facilities can support each other better during disasters. Local healthcare facilities can transfer or refer patients easily to regional hospitals to keep local facilities from getting overwhelmed; hospitals also can transfer or refer patients to the trauma center. Regional hospitals also have systems in place to allocate resources like generator fuel or medical supplies to help local hospitals.
The Puerto Rican Department of Health now has a system in place to monitor the real-time status of hospitals on the island so it knows when hospitals are open, closed, on generator power, or likely to need generator fuel when the power is out for an extended period of time. Sharing resources, situational awareness, and a common operating picture for meeting the medical needs at the regional level helps ensure there are no shortfalls.
Territory organizations now have the tools and resources they didn’t have before to help people with access and functional needs for the most vulnerable populations — children, the elderly, and people who are at-risk because of their health conditions.
The U.S. Virgin Islands’ hospital has greater dialysis capability than in the past to support more dialysis patients if regular dialysis centers are not available after storms.
Thankfully, Dorian’s impact to Puerto Rico and the U.S. Virgin Islands was not significant, but the storm presented an opportunity to test and evaluate the progress the territories have made with help of the ASPR Division of Recovery since Hurricanes Irma and Maria. Health officials and emergency managers know that the question is not “if,” but “when” the territories will face another impactful storm — but it was Hurricane Dorian that proved Puerto Rico and the U.S. Virgin Islands are more resilient, stronger, and better prepared to face the challenges brought by future disasters.
Visit https://www.phe.gov/about/oem/recovery/Pages/default.aspx to learn more about
disaster recovery for health and social services, including tools that can help health and emergency managers plan for and recover from disasters more effectively. The guides, sample plans, measures and other tools can help you learn more about your community and leverage resources to help your community recover.
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.