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Vector Expedited Review Voucher (VERV) stakeholder event held in Washington DC 20th March 2024

Duke University and US Government relations firm DC Legislative and Regulatory Services co-sponsored a Vector Expedited Review Voucher (VERV) stakeholder event in Washington DC on 28th February, 2024.  The purpose of the meeting was to explain and discuss the December 2023 Pesticide Registration (PR) notice published by the Environmental Protection Agency (EPA) regarding the VERV program.

Held at the Duke University’s “Duke in DC” office on Pennsylvania Avenue, the event was attended by the EPA, the Innovative Vector Control Consortium (IVCC), the agrochemical industry and other private and public sector organisations, including the American Mosquito Control Association (AMCA).  All are stakeholders in the development of innovative vector control tools to support malaria eradication.

Jeff Moe, adjunct professor at the Duke Global Health Institute, and a co-author of the 2017 Health Affairs article which proposed VERV, opened the event by reflecting on the successful introduction of the US Food and Drug Administration’s Priority Review Voucher (PRV) programme in 2007: “PRV 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.”

Chris Larkin, Director of Operations and Communications at IVCC, who took part in a panel session, added: “Incentives like the VERV program are needed to ensure that innovative vector control tools are developed and made available with new modes of action to help address the threat of insecticide resistance which is critical for the fight against diseases such as malaria which still claim over 600,000 lives every year.”

Participants heard from EPA representatives including Susan Jennings (Senior Advisor for Public Health, Office of Pesticide Programs), Stephen Scheibel (Pesticide Registration Improvement Act (PRIA) Coordinator,) and Billy Smith (Director, Registration Division, Office of Pesticide Programs).  They described the operation of the VERV program including the eligibility criteria to receive a VERV award.  Jennings explained that to be eligible for a voucher, active ingredients must demonstrate efficacy against insecticide-resistant mosquitos (per efficacy guidelines), have a novel or unique mechanism different from other insecticides already registered by the agency for mosquito control, and target mosquitos which transmit disease.

Jennings added that, whilst active ingredients must not be contained in any EPA registered pesticide product, a registrant may petition the EPA to issue a voucher for a repurposed agricultural insecticide by demonstrating a significant public health benefit.

Jennings also highlighted that any novel mode of action will be assessed on case by basis by the Office of Pesticide Program (OPP) through the consideration of factors such as:

Full details of the EPA VERV program can be found at: https://www.epa.gov/mosquitocontrol/vector-expedited-review-voucher-verv-program

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

www.vectorvoucher.info

 

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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