A U.S. Food and Drug Administration (FDA) official told Congress March 2 that an “urgent need” exists to accelerate development of medical products to combat the Zika virus and that the agency will “leverage its authorities to the fullest extent” to aid that process.
Luciana Borio, MD, an FDA assistant commissioner, sounded that alarm during a House Committee on Energy and Commerce hearing, Examining the U.S. Public Health Response to the Zika Virus. Borio told the committee that the FDA is working closely and collaboratively with the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and other agencies to combat Zika.
While the FDA has yet to clear a commercially available diagnostic test for Zika, it has authorized limited emergency use of a CDC-specific immunoglobulin M (IgM) antibodies test developed for the qualitative detection of Zika virus. This test already has been made available to 19 states and territories, Borio said.
But there remains an “urgent need to accelerate medical product development programs,” she said in her statement. “FDA is fully prepared to leverage its authorities to the fullest extent practicable to help accelerate the development and availability of safe and effective products.”
Increased risk of Zika transmission by blood transfusion due to lack of a screening test prompted the FDA recently to issue recommendations for donor screening and deferral and product management of whole blood and blood components. Further, Borio said, the FDA is developing guidance that will address appropriate donor deferral measures for human cells, tissues, and cellular and tissue-based products.
America’s Essential Hospitals has established a resource page for those with an interest in this emerging public health threat. Essential hospitals provide a significant volume of public health and emergency preparedness services and stand ready to support the nation’s response to Zika virus. Visit this page regularly for new and updated information.
Contact Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.