House passes legislation adding Zika virus to FDA’s Priority Review Voucher Program

The U.S. House of Representatives passed legislation on Tuesday to add the Zika virus to the U.S. Food and Drug Administration’s (FDA) Priority Review Voucher Program.

The legislation, the Adding Zika Virus to the FDA Priority Review Voucher Program Act, S. 2512, would add Zika virus to the FDA’s list of tropical diseases under the program, allowing a voucher to be awarded to the sponsor of a new drug or biological product that is approved for the prevention or treatment of a tropical disease.

“As we approach the summer months, the threat of the Zika virus is real and we must do all we can to ensure we’re prepared,” Energy and Commerce Committee Chairman Fred Upton (R-MI) said. “This bill is a step in the right direction. There’s still a lot we just don’t know about Zika, which makes research and development of vaccines and potential treatments all the more critical.”

The bill follows early February briefings on the Zika virus for bipartisan committee leaders from the Centers for Disease Control and Prevention, the National Institutes of Health, and the Department of Health and Human Services (HHS). Following an Oversight and Investigations Subcommittee hearing on the Zika virus in March, HHS leaders were pressed by committee leaders on the administration’s response to the Zika virus, as well as the lack of sufficient diagnostic testing.

“The current status of diagnostic testing for Zika is alarming,” Upton and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA) wrote in a March 29 letter to HHS. “The most widespread of the tests – which measures the presence of the virus in the blood – only works if administered within five to seven days of the onset of symptoms. Given that nearly 80 percent of individuals infected with Zika appear to be asymptomatic, this test is insufficient for most people who will become infected with Zika.”

S. 2512, which was previously approved by the Senate in mid-march by unanimous consent, now heads to President Barack Obama’s desk.