Over the last decade, our nation has responded to deliberate biological attacks – the mailing of anthrax-laden letters – and severe naturally-occurring disease outbreaks including SARS and the 2009-H1N1 flu pandemic. As an industry, biotechnology can help improve our nation’s capacity to prepare and respond to natural disasters, bioterrorist attacks, and outbreaks of infectious disease.
The Biomedical Advanced Research and Development Authority (BARDA) was established to support the advanced development and procurement of drugs, vaccines, diagnostics and other products that are considered priorities for national health security. BARDA partners with industry to develop medical countermeasures (MCMs) to address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) events.
BARDA funding bridges the “valley of death” characterizing the late stages of product development. BARDA’s support ensures continuity of funding at a critical point for medical countermeasures developed by industry or emerging from the basic research and preclinical development activities sponsored by the National Institutes of Health (NIH).
In March 2013, the Congress passed H.R. 307, the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), which reauthorizes funding for BARDA and reaffirms the U.S. government’s commitment to its mission. The bipartisan legislation directs BARDA to promote innovations in new MCM technologies and to strengthen the MCM pipeline.
PAHPRA also provides needed clarity for the regulatory process for medical countermeasures at the Food and Drug Administration and strongly encourages the Agency to work with product sponsors to develop regulatory management plans, provide technical assistance and help solve regulatory and scientific issues.
BARDA aims to manage resources efficiently, strengthen public-private partnerships, and promote the broad categories of countermeasures that BARDA is most interested in pursuing to protect health and save lives in a public health emergency.
Biotech companies are willing and active partners in the national security endeavor. Our industry plays a central role in ensuring the effective development of MCMs to protect our nation’s citizens against CBRN threats, whether naturally occurring or man-made.
Strengthening the pipeline of medical products, drugs and devices that will safeguard the nation during an emergency or pandemic is vital to our national security.
To learn more about how our industry can accelerate the development of medical countermeasures working with BARDA, please watch this video interview with BIO’s Phyllis Arthur and the Director of BARDA, Dr. Robin Robinson.