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IVCC welcomes the publication of Regulatory Guidance on the Vector Expedited Review Voucher Program 4th January 2024

The Vector Expedited Review Voucher Program offers registrants of vector control tools a financial incentive, a voucher, in reward for registration of novel public health insecticides that can combat vectors of malaria and other diseases.

In a major step forward for vector-borne disease control, the US Environmental Protection Agency (EPA) announced the establishment of the regulation for a Vector Expedited Review Voucher (VERV) Program. The notice, issued on Thursday 18th of December 2023, includes the eligibility criteria and processes regarding how to apply and qualify for a voucher under the VERV Program.

The VERV rewards the registrant of a new public health insecticide with a voucher to receive an expedited registration review of a second, potentially more profitable product. Getting the second product to market faster generates value for the manufacturer which helps mitigate the investment costs typical in public health insecticide development. A registrant can also sell the awarded voucher.

Justin McBeath, CEO of IVCC and advocate for establishment of the VERV program said: “The Vector Expedited Review Voucher is a significant step forward. Keeping industry engaged in the discovery and development of new technologies to combat vectors of malaria and neglected tropical diseases is essential. IVCC welcomes the publication of VERV eligibility criteria, which brings clear guidance for industry partners and stakeholders wanting to benefit from this incentive. The Program, as explained with the newly issued EPA guidance, will provide an additional financial incentive for public health insecticide development, and help to sustain product innovation into the future.”

The establishment of the program has been championed by IVCC following a policy proposal by Duke University. It was signed into US Law in December 2022. IVCC and Duke University began work on VERV in 2015.

VERV is modelled on the US Food and Drug Administration’s (FDA) Priority Review Voucher program legislated in 2007 (Sec. 524 FDA Amendments Act), which offers a priority review of a second pharmaceutical product as a reward for new treatments targeting selected diseases.

Jeffrey Moe, Adjunct Faculty of the Duke Global Health Institute, a co-author along with other Duke faculty proposing the PRV programme and the new VERV added: “PRV has had a positive impact on the development of treatments with limited profitability for neglected tropical diseases. The VERV programme can, like PRV, stimulate the development of innovative vector control solutions to help us better control, and hopefully eradicate, diseases such as malaria.”

IVCC, Duke University and stakeholders will continue to work with the US Environmental Protection Authority (EPA) as it implements the VERV programme to stimulate investment in new public health insecticides and products for the control of vector-borne diseases.

 

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For further information contact:

Chris Larkin, Director of Communications and Operations

Christopher.larkin@ivcc.com

+44 (0)7712 402498

 

Note to editors:

Further details about the Vector Expedited Review Voucher (VERV) are available at:

www.ivcc.com/vector-control/vector-expedited-review-voucher-verv/

www.vectorvoucher.info

 

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