FDA takes action against Zika virus
FDA Commissioner Robert Califf, MD, and Acting Chief Scientist Luciana Borio, MD, discuss the agency's efforts to combat the Zika virus outbreak. "We are engaged with our partners across the U.S.
FDA Commissioner Robert Califf, MD, and Acting Chief Scientist Luciana Borio, MD, discuss the agency's efforts to combat the Zika virus outbreak. "We are engaged with our partners across the U.S. Government, the private sector, and the international community—including the World Health Organization and ANVISA (the Brazilian Health Regulatory Agency)—to help minimize the impact of this outbreak," the note. FDA is actively working with manufacturers to support their diagnostic development programs, helping to ensure that their tests are properly validated before they are used to inform patient care. In 2016 the agency has authorized the use of five diagnostic tests for Zika virus under FDA’s Emergency Use Authorization authority—four tests to diagnose active infection and one test to assess whether individuals who may have recently been exposed to Zika were actually infected. There are currently no vaccines or treatments for Zika virus that have been shown to be safe and effective. FDA continues to actively engage with commercial and government developers, including the NIAID and BARDA, to advance the development of investigational vaccines for Zika virus as soon as possible. During outbreak situations, fraudulent products claiming to prevent, treat, or cure a disease almost always appear. FDA is monitoring for fraudulent products and false product claims related to Zika virus and will take appropriate action to protect consumers when necessary.