Today, U.S. Senator Markwayne Mullin (R-OK) was announced as the Senate Republican lead for a bipartisan bill to encourage the prevention and treatment of Valley Fever—a fungal disease endemic to the Southwestern United States. If passed, this legislation would add Valley Fever to the Food and Drug Administration (FDA)’s Tropical Disease Priority Review Voucher (PRV) list.

“Humans and animals in the American Southwest are contracting Valley Fever through fungus that grows in the dirt and soil, costing the U.S. healthcare system $3.9 billion each year,” said Sen. Mullin. “There are few drugs currently available to treat this disease, but PRV programs can help incentivize the development of treatment that will improve health care outcomes, lower costs, and ultimately save lives. I’m glad to join Senator Mark Kelly and Congressman Kevin McCarthy in leading this important bipartisan legislation to improve care options for Western Oklahoma.”

Background:  

• Valley fever infection rates have been steadily increasing since 2014, with Oklahoma’s most prominent cases being in the Oklahoma Panhandle. 
• Few drugs are currently available to treat certain tropical diseases given their small market or potentially limited profitability. 
• To help provide incentives for the development of drugs for tropical diseases, Congress created PRV programs, which award PRVs to drug sponsors that develop drugs for tropical diseases. 
• The PRV may be redeemed later to receive priority review from FDA with a targeted review time of 6 months, rather than the 10-month standard review, for a drug application of the PRV holder’s choice. 
• The PRV can also be sold to other companies and the current value of a PRV is around $80M-$130M. 
• Some people, especially pregnant women, and people with weakened immune systems, are at risk of developing a more severe form of coccidioidomycosis which in rare instances can lead to death. 

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