Adding Zika Virus to the Fda Priority Review Voucher Program Actby Representative Susan W. Brooks
Posted on 2016-04-12
BROOKS of Indiana. Mr. Speaker, I move to suspend the rules and
pass the bill (S. 2512) to expand the tropical disease product priority
review voucher program to encourage treatments for Zika virus.
The Clerk read the title of the bill.
The text of the bill is as follows: S. 2512 Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE.
This Act may be cited as the ``Adding Zika Virus to the FDA Priority Review Voucher Program Act''.
SEC. 2. EXPANDING TROPICAL DISEASE PRODUCT PRIORITY REVIEW VOUCHER PROGRAM TO ENCOURAGE TREATMENTS FOR ZIKA VIRUS DISEASE.
Section 524(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(3)) is amended-- (1) by redesignating subparagraph (R) as subparagraph (S); (2) in subparagraph (Q), by striking ``Filoviruses'' and inserting ``Filovirus Diseases''; and (3) by inserting after subparagraph (Q) the following: ``(R) Zika Virus Disease.''.
The SPEAKER pro tempore. Pursuant to the rule, the gentlewoman from Indiana (Mrs. Brooks) and the gentleman from Texas (Mr. Gene Green) each will control 20 minutes.
The Chair recognizes the gentlewoman from Indiana.
General Leave Mrs. BROOKS of Indiana. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and insert extraneous materials in the Record on the bill.
The SPEAKER pro tempore. Is there objection to the request of the gentlewoman from Indiana? There was no objection.
Mrs. BROOKS of Indiana. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in support of S. 2512, which would add the Zika [[Page H1603]] virus to the FDA Priority Review Voucher program.
S. 2512 is companion legislation to H.R. 4400, authored by Representative Butterfield and myself.
Under the FDA Priority Review Voucher program, once a vaccine or therapy for a disease on the FDA Priority Review Voucher program has been developed, the manufacturer of that product receives a voucher that can be used to fast-track review by the FDA of another product in the development pipeline. At zero cost to the taxpayer, this is a significant incentive for private industry to invest the hundreds of millions of dollars and the many man-hours it takes to produce a vaccine or treatment.
In a world where we can travel across oceans in a matter of hours, an outbreak that begins on a different continent can arrive in the United States in a very short period of time. As Americans travel to and from Central and South America, we are beginning to see more Zika cases here at home.
This doesn't just affect citizens in tropical areas, but in places as far north as Indiana as well. In my district, a nurse educator at Indiana Wesleyan University contracted the disease in January when she traveled to Haiti to teach a seminar in transcultural nursing.
Most people don't experience symptoms if they contract the Zika virus, but women who become pregnant or trying to become pregnant and their babies are at risk. For babies, that can include serious birth defects that may lead to mental and physical disabilities. The threat is multi-generational, and we still don't know a lot about this disease. We can't treat it right now and we can't prevent it right now. That is a huge problem.
The Zika virus is not the only biological threat we face to our public health and national security. Right now, despite the steps taken during and after the Ebola epidemic, we remain largely reactionary in our response to pandemics and biological threats. We need to be more proactive in our response to all pathogens, like the Zika virus, that are a threat to our national security and the health of our citizens.
A more proactive approach would be to incentivize the development of vaccines and treatments through the FDA Priority Review Voucher program, known as PRV, before they reach the advanced stage of contagion.
This past October, a bipartisan Blue Ribbon Panel on Biodefense released a report on America's vulnerabilities to a biological event. The panel found that the underlying problem isn't a specific disease, but our country's inability to mobilize quickly and effectively to identify, contain, treat, and eliminate any kind of biological threat to people in the United States.
Incentivizing the research into a neglected tropical disease like Zika is a necessary, but not final, step. Our work is not done. As we move forward, we need to expand the PRV program to other items on the Department of Homeland Security's Material Threat list. Doing so will put us on offense and better prepare us for the next outbreak, whatever it might be.
Today we have an opportunity to take meaningful action in a fight against this deadly disease. I applaud Speaker Ryan and Leader McCarthy for recognizing the severity of the threat and allowing for this bill's timely consideration.
I have welcomed the opportunity to have worked with Representative Butterfield on this important issue, and Chairman Green and others on the Energy and Commerce Committee who recognize that the Zika virus is of significant threat not only to people in other parts of the world, but actually the people in the United States.
Mr. Speaker, I reserve the balance of my time.