The Biomedical Advanced Research and Development Authority (BARDA) has achieved a milestone, with more than 50 approvals by the U.S. Food and Drug Administration (FDA) over the past 12 years of health security solutions it helped develop.
The approvals and licensures are for products that address some of our nation’s most challenging health security threats. Eight of the now 51 approvals have been achieved within the past year alone. The solutions range from a pandemic influenza vaccine licensed in 2007 to an anthrax diagnostic test approved earlier this month, BARDA Director Rick Bright explained.
Bright explained that 19 of the 51 approvals are vaccines, diagnostics, or treatments that increase the nation’s preparedness for influenza pandemics.
Many of these solutions are for health threats that involve bacteria or chemicals for which clinical trials cannot be performed in humans. To overcome this hurdle, BARDA worked with the FDA to get approval for such products using the Animal Rule. BARDA has engaged the private sector in these solutions by providing funding, technical assistance, and focusing on products that could have multiple uses and commercial uses. BARDA has partnered with more than 300 companies on these products over the past 12 years.
“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,” Bright recently wrote in a blog post on the government’s Public Health Emergency web site.