Brooks calls on FDA to act on Zika virus

U.S. Rep. Susan Brooks (R-IN) led 70 members of Congress on Friday in a letter to U.S. Food and Drug Administration (FDA) Acting Commissioner Dr. Stephen Ostroff calling for Zika virus to be added to the FDA Tropical Disease Priority Review Voucher (PRV) Program.

The letter follows a Monday meeting by the World Health Organization (WHO) to address the growing threat that Zika virus poses in the Americas.

“Zika virus is spreading rapidly in South and Central America,” Brooks said. “We must act to ensure that our citizens are protected, and that we are doing everything we can to prevent an outbreak of Zika virus in the United States. A natural first step would be for the FDA to exercise its authority and fast-track the development of vaccines or treatments for Zika virus helping save lives and prevent infections.”

Developing new vaccines and treatments takes several years and cost hundreds of millions of dollars, but placing the Zika virus in the FDA Tropical Disease PRV Program would incentivize research and development of vaccines and therapies to fight the virus by allowing a PRV to be requested by drug manufacturers, who would also receive expedited FDA consideration.

“While the development of vaccines is already underway, it could take years before a vaccine is widely available,” Brooks said. “In a situation like this — when the WHO has estimated that up to four million people in the Americas will be infected by the end of the year — we don’t have the luxury of time. I will continue to pursue actions and legislative fixes that will help protect our country from dangerous diseases and help arm our researchers with the resources they need to combat the challenges of any potential epidemic or outbreak before it occurs.”

Brooks cosponsored legislation, H.R. 4400, on Feb. 1 that would add Zika virus to the FDA Tropical Disease PRV Program.

Zika virus symptoms are considered relatively mild and include fever, rash, joint pain and red eyes. Symptoms themselves are only developed by one-in-five infected with the virus. Zika virus, however, has also been linked to a surge in infants born with unusually small heads and underdeveloped or damaged brains.

There is no widely available test for Zika virus infection, nor is there a vaccine.

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