It’s rare for an academic paper to turn into federal law, even more so when it happens a second time.
Professor David Ridley, Faculty Director for Health Sector Management at Duke University’s Fuqua School of Business, and colleague Jeffrey L. Moe, professor at Duke Global Health Institute, accomplished this feat with a new program called Vector Expedited Review Voucher (VERV), which the U.S. Congress passed into law and President Biden signed in December 2022.
The VERV program, as described in a 2017 paper, proposes a voucher system to incentivize agrochemical companies to develop new insecticides to fight selected vector-borne diseases such as Dengue fever, malaria, West Nile virus and Zika. It is the sequel to a similar program that Ridley, Moe, and colleagues proposed in 2006 to jump-start the development of new drugs for tropical diseases, a program then-President George W. Bush signed into law in 2007.
“This one took longer," Ridley said. “We were lucky the first time, because a reporter told us which U.S. Senators were likely to be interested. Last time, it took us a year and a half. This time, it took five years.”
While vaccines and drugs are essential to cure and prevent diseases, a more comprehensive and cheaper approach should include the use of safe pesticides to stop the pests before they infect people, Ridley and colleagues write in the paper. Bed nets treated with pesticides have saved thousands of lives. But new products are needed.
“No new class of pesticides has been developed in 40 years,” Ridley said. “Mosquitoes are becoming resistant to current pesticides, and there is not a sufficient financial incentive to develop new products because the return on investment is insignificant.”
That’s where the incentive voucher helps fill the gap.
The VERV voucher, proposed by Ridley, Moe, and former IVCC CEO Nick Hamon, rewards companies willing to create new pesticides against targeted diseases with a faster review process of a second – and more lucrative – product, such as a crop-protecting pesticide. It is similar to the 2007 FDA’s Priority Review Voucher (PVR) program that Ridley, Moe, and retired Duke professor Henry Grabowski designed.
“It’s a prize, a way to encourage companies to produce pesticides that are not profitable enough,” Ridley said.
The U.S. Environmental Protection Agency’s review process usually takes 14, 18 or 24 months, depending on the product category. VERV would expedite the decision by 2, 4 or 6 months depending on the category.
The paper estimates the monetary value of the EPA’s expedited review to be dozens of millions of dollars, because of the time-value of money and the longer period of sales.
The voucher can be used directly by the EPA applicant or sold, although Ridley doesn’t think VERV vouchers will be sold as much as the 2007 FDA’s PRV vouchers, due to the smaller scale of pesticide markets compared to the market for drugs (see this tracker about the FDA program, showing the vouchers awarded and those that have been sold so far).
A challenge that the VERV law wants to address better than the 2007 law is global access for developed pesticides. “These kinds of products have costs that are near or even above the ability to pay for people living in lower-income countries,” Ridley said.
VERV will tackle this issue by requiring the companies to submit their global plans in advance. “Companies need to report what prices they will charge, where they will make the product, and in which countries they will make the product available. Hopefully this will help them plan and pressure them to follow through. We need to be sure that people get the products,” Ridley said.
The success of the program will depend on keeping agrochemical companies at the table of public health innovation, said Moe. “There are three to five promising products in the pipeline, which could emerge successfully as vector-control insecticides,” Moe said, quoting IVCC studies. “These companies have small portfolios of products, mostly directed to agricultural use. If we convince them to add small investments and pivot these promising active agents to a public health use, we might have one or two new insecticides awarded in the next few years.”
“And there is nothing that breeds success like success itself,” Moe concluded.