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April 12— Legislation (S. 2512) to accelerate development of countermeasures to combat the Zika virus passed the House April 12, clearing the way for approval by the White House.
The bill, which would add the Zika virus to the list of diseases that are eligible for the Food and Drug Administration's priority review voucher program, passed the Senate in mid-March . The priority review voucher program allows the developer of a vaccine or treatment for a qualifying tropical disease to receive a voucher for FDA priority review for a second product of its choice.
The House passed S. 2512 by voice vote.
“The Zika virus is spreading rapidly, and to fight back, we need to make sure we have the necessary tools to prevent and treat the disease,” Sen. Al Franken (D-Minn.), the bill's primary sponsor, said in an April 12 statement. “Our bipartisan bill will encourage innovators to help stop the virus in its tracks, and I’m very pleased that we got the measure across the finish line. This is an important step to combat Zika, and I look forward to President Obama signing it into law.”
But the Zika priority review bill is moving forward as Republican appropriators have pushed back on President Barack Obama's separate request for $1.9 billion in supplemental spending to combat the Zika virus—which includes about $130 million for the National Institutes of Health to carry out work on vaccine development.
Appropriators in both the House and the Senate called on the White House to re-purpose Ebola dollars. The White House transferred $589 million, which includes about $40 million in funding for Zika .
But Anthony S. Fauci, director of the NIH's National Institute of Allergy and Infectious Diseases, said during a White House press conference April 11 that the stopgap funding isn't enough. “If we don't get the money that the president has asked for, we're not going to be able to take it to the point where we've actually accomplished what we need to do,” Fauci said. “The money that's being transferred over from the Ebola account will help bring us a little bit further, but it's still not what we want. When the president asked for $1.9 billion, we needed $1.9 billion.”
The Zika virus has been spreading throughout the Americas and has primarily caused alarm for its link to serious birth defects. Anne Schuchat, principal deputy director of the Centers for Disease Control and Prevention, said April 11 that the latest research indicates the virus is even more dangerous than previously known. During the same press conference where Fauci spoke, she said the virus is linked to a broader set of complications in pregnancy, not just microcephaly but also prematurity, eye problems and some other conditions.
She also said the Aedes aegypti mosquito that spreads the virus is now present in about 30 states, instead of the dozen or so that had been previously identified.
Phyllis Arthur, managing director for infectious diseases and diagnostic products for the Biotechnology Innovation Organization, told Bloomberg BNA that the supplemental funding and the priority review voucher programs are interconnected and complementary incentives to spur development of vaccines for the benefit of the public health. BIO has endorsed S. 2512.
Fauci has told lawmakers during Zika hearings that the NIH's job is to “de-risk” the chances that a vaccine is safe and effective by conducting or funding much of the early phase testing that allows the private sector to come in and conduct the clinical trials that will develop the drug. He told Bloomberg BNA in previous statements the NIH can't move the vaccine forward to the safety and efficacy testing stage without the supplemental money. NIH Director Francis S. Collins also told Bloomberg BNA that the stopgap money wasn't enough to develop a vaccine.
BIO's Arthur told Bloomberg BNA if the NIH isn't able to get enough money to get to phase II testing, “I think we get stuck.”
“If indeed the money comes to NIH and BARDA [more slowly], that is how slow the development will go,” she said, referring to the Biomedical Advanced Research and Development Authority.
“It’s pivotal for both NIH and BARDA to have the funds they need to carry forward at least the phase II work, if not beyond because otherwise, it’s going to take a lot longer. A lot of the companies doing the initial work are the smaller biotechs. Those companies aren’t going to be able to find private capital to be able to go forward and do phase II and phase III trials. This doesn’t mean there’s not a partner on the other side. But you’ve got to get over the phase II hump.”
A spokeswoman for the House Appropriations Committee told Bloomberg BNA that the committee's position remains unchanged from an April 6 statement in favor of repurposing Ebola dollars for the Zika virus. “It is quickest and most effective to use existing funds for these response activities now. If additional resources are needed, they can be considered in the FY 2017 Appropriations process,” the House aide told Bloomberg BNA April 12.
But when asked during the White House press conference what happens if the stopgap funding runs out, Fauci replied, “Hopefully that will never happen, but we'll have to start raiding other accounts, and very important research on other diseases is going to suffer and suffer badly. So, I almost can't imagine that will happen.”
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More information on the bill is available https://www.congress.gov/bill/114th-congress/senate-bill/2512.
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