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Gene G.
Democrat TX 29

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  • Adding Zika Virus to the Fda Priority Review Voucher Program Act

    by Representative Gene Green

    Posted on 2016-04-12

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    GREEN of Texas. Mr. Speaker, I yield myself such time as I may consume.



    Mr. Speaker, I rise to speak on S. 2512, the Adding Zika Virus to the FDA Priority Review Voucher Program Act.

    Representatives G.K. Butterfield and Susan Brooks led this legislation in the House and members of our Energy and Commerce Committee. I want to thank them for their commitment to mitigating the Zika virus outbreak.

    S. 2512 will add Zika virus to the list of qualified tropical diseases under the Tropical Disease Priority Review Voucher program, PRV.

    Zika virus is among several recent and emerging global health threats that remind us of the need for effective incentives for research and development of neglected tropical diseases, and for infectious diseases at large. Neglected tropical diseases, or NTDs, represent more than 10 percent of the global disease burden. However, only 4 percent of all new drugs and vaccines approved across the globe in the next decade were for NTDs.

    The NTD Priority Review Voucher program was created by Congress in 2007 to be a much-needed incentive for products that diagnose and treat such diseases for which market forces fall short.

    The Adding Ebola to the FDA Priority Review Voucher Program, which was signed into law in 2014 and was led by myself and Representative Marsha Blackburn, gave the FDA the authority to add diseases to the program by issuing an order. The agency has already used this authority to add Chagas to the program. While the program is successful, it could be more so.

    Currently, there is no requirement for a product to be novel or that it be made available and affordable for the patients whom awarded products are designed to help. It should be amended to strengthen its effectiveness. This can be done by adding a novelty requirement and an access strategy requirement, like what is mandated under the Rare Pediatric Disease Priority Review Voucher program.

    This legislation did not go through the House Energy and Commerce Committee, so the opportunity to discuss the NTD PRV program was not taken. I hope to work with my colleagues to incorporate amendments on future legislation that will improve the functioning of the program. Doing so will allow it to incentivize novel programs and ensure they are widely accessible to patients in need.

    Improvements to the PRV program would be one important step toward ensuring we have effective strategies to incentivize both research and development for NTDs. Broader changes are urgently needed to ensure the R&D system delivers new vaccines, diagnostics, and treatments to patients presenting and exposed to NTDs and resistant infections.

    I look forward to working with my colleagues on additional mechanisms to ensure R&D for these emerging threats is successfully and properly incentivized. Doing so is necessary for the flourishment of biomedical innovation in this space.

    I fully agree with the bill sponsors that we need to do all we can to respond to the Zika virus by facilitating the development of and access to medical products as quickly as possible.

    The administration has asked Congress for $1.9 billion in emergency funding to enhance our efforts to prepare and respond to the outbreak, both around the world and here at home.

    This legislation is arguably a step in the right direction, and I again thank the sponsors for their commitment and leadership. However, this bill far from renders the emergency supplemental funding request unnecessary. Dedicated funds, some of which will go towards medical product development to respond to the Zika virus, are essential to sustaining Health and Human Services' response efforts.

    I urge my colleagues to ask swiftly to approve emergency funding for a robust Zika virus outbreak response.

    Mr. Speaker, I reserve the balance of my time.

    Mrs. BROOKS of Indiana. Mr. Speaker, I reserve the balance of my time.

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