  Spraying to prevent malaria. Vanuatu 2009. Photo: AusAID This is the second article in a two-part series regarding the intertwined problems of growing insecticide resistance and the lack of investment in novel public health use insecticides (Part I can be found in the November/December 2023 issue of IPC). A new US incentive programme aims to mitigate these problems. Reading the US Environmental Protection Agency (EPA) announcement of the new programme raises questions which EPA will need to clarify. Our questions and others will be discussed by stakeholders and EPA on February 28, 2024 in Washington, DC. Readers can register to attend the meeting using the link at the bottom of this article.
On December 18, 2023, EPA released Pesticide Registration (PR) Notice 2023-2, to announce the establishment of the Vector Expedited Review Voucher (VERV) Programme, which was mandated in the Pesticide Registration Improvement Act of 2022 (PRIA 5). VERV is a new incentive to stimulate the development of novel mosquito control products to help prevent the spread of mosquito-borne diseases such as malaria, dengue fever, and Zika.
VERV is modelled after the US Food and Drug Administration’s (FDA) Priority Review Voucher (PRV) programme legislated in 2007 (Sec. 524 FDA Amendments Act), which offers a priority review of a second product as a reward for new treatments targeting selected diseases. While VERV and PRV are built upon the same value-creating model, there is a key difference between the two agencies: EPA does not have pre-existing, separate processes to accelerate the review of a product. FDA’s four expediting programmes, accelerated approval, breakthrough, fast track, and priority review, are dedicated processes which are differentiated from standard reviews.
Under the law, EPA receives up to $500,000 annually for fiscal years 2022-2027 from the EPA Expedited Review and Reregistration Fund (“maintenance fee fund”) for VERV programme administration. (FIFRA).
The availability of resources raises the first of several potential questions regarding the new VERV programme.
Q: How will EPA use the available funding to create a process to expedite the review when an awarded voucher is exercised on a second product?
Q: Does EPA’s recent experience of expediting the review of products effective against the SARS-CoV-2 virus that causes Covid-19, provide a benchmark for a differentiated expediting process? (EPA COVID-related Expedited Product Reviews)
VERV rewards the registrant of a new public health use insecticide, the “vector product”, with a voucher. The registrant submits the vector product for the applicable PRIA category and pays the relevant registration fee. The review of the vector product follows the standard decision review timing for its PRIA category – it is not expedited. If the product is eligible and approved, the registrant is awarded a voucher. The eligibility criteria for VERV are described at EPA’s VERV website. (EPA VERV Website)
Read the full article in the JanFeb2024 sample copy
Authors: Jeffrey Moe*, Alan Ayers**, Justin McBeath***
* Adjunct Professor, Duke Global Health Institute, Duke University, jmoe@duke.edu
** Former executive, Bayer Crop Sciences, alan.ayers@outlook.com
*** Chief Executive Officer, Innovative Vector Control Consortium, justin.mcbeath@ivcc.com
Published in International Pest Control – January/February 2024 issue.
The post VERV programme – questions for the EPA first appeared on International Pest Control Magazine. 
Content mobilized by FeedBlitz RSS Services, the premium FeedBurner alternative. | 