The Power of Partnership: BARDA Ushers in 50th FDA-Approved Product for Health Security

By Rick Bright, Ph.D.

(Released 11 October 2019) 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.

Released by the U.S. Department of Health and Human Services, Assistant Secretary for Preparedness and Response (ASPR). Click here for source.