By Congressman Tom Cole
Twenty years ago, in 2004, Congress passed the Project BioShield Act, which established the Biomedical Advanced Research and Development Authority, also known as BARDA. Created in the shadow of the tragedy on September 11, 2001 and the global war on terror, BARDA supports the development and approval of medical countermeasures, which are FDA-regulated products used to prepare our country to respond to chemical, biological, radiological, and nuclear threats posed by our nation’s adversaries.
Utilized many times since its creation in 2004, BARDA has proven to be crucial when responding to these types of unanticipated threats. Yet, many of the products necessary to respond to a chemical, biological, radiological, or nuclear attack lack robust commercial markets. Therefore, federal investment is required to better safeguard American lives. This is why, as Chairman of the House Appropriations Committee, I am committed to continuing to use my position to strengthen medical supply chains and biodefense capabilities through BARDA.
BARDA plays many roles within the structure of the federal government and the Department of Health and Human Services. Included in these roles is providing industry partners with not just financial support, but also guidance to help them navigate the FDA approval process, ensuring the American public has access to potentially lifesaving products when faced with a public health emergency. This FDA approval process is critical to guaranteeing that medical devices are both safe and effective. However, the exacting standards of the FDA and the costly, complicated, and at times convoluted nature of the approval process creates many potential dead ends for products that would have eventually proven effective – further demonstrating the value of assistance from BARDA throughout this process. In fact, I was happy to see that just this week the FDA approved the 100th medical countermeasure developed with BARDA support.
It is important to note that many of the 100 products BARDA escorted through the FDA approval process have important everyday applications. For example, OPVEE, a nalmefene-based nasal spray approved by the FDA in 2023, increased the countermeasures available to first responders and communities working to combat powerful synthetic opioids, like fentanyl. Furthermore, the FDA-approved NexoBird and Silverlon assist first responders and hospitals across the country to ease the suffering of burn victims. Finally, BARDA has ushered broad-spectrum antibiotics that have displayed efficacy against antimicrobial resistant viruses, parasites, funguses, and bacteria through the FDA approval process.
In conclusion, although it was created as a response to an increasingly uncertain global security landscape, the value of BARDA extends well beyond man-made threats. Therefore, as a Congress, we must continue to support this program, as it is essential to ensuring our nation is prepared to face the evolving multi-polar threat landscape of today’s world.
