Lawmakers urge investment for Valley Fever drug, vaccine development

Legislators have requested Health and Human Services (HHS) and the Food and Drug Administration (FDA) include Valley Fever in the Tropical Disease Priority Review Voucher (PRV) Program.

Rep. Kevin McCarthy (R-CA) spearheaded a recent effort to forward correspondence to HHS Secretary Alex Azar and FDA Acting Commissioner of the U.S. Food and Drug Administration (FDA) Norman Sharpless, advocating the inclusion of Coccidioidomycosis, commonly referred to as Valley Fever, in the PRV initiative.

Sens. Martha McSally (R-AZ) and John Cornyn (R-TX) and Reps. David Schweikert (R-AZ), Ken Calvert (R-CA), Paul Cook (R-CA), Duncan Hunter (R-CA), Doug LaMalfa (R-CA), Tom McClintock (R-CA), Devin Nunes (R-CA) and Rob Bishop (R-UT) joined McCarthy on the letter.

“Drug development is a complicated, time-consuming, and capital-intensive process,” the lawmakers wrote. “This undertaking only becomes that much more difficult when a disease afflicts a smaller population of individuals. Given the extremely low prevalence in developed nations and resulting lack of a feasible market, combined with the disease disproportionately impacting poor and marginalized populations, including pregnant women, children, and minorities, we believe Valley Fever merits inclusion on this list based on criteria set forth in statute and regulation.”

The legislators maintain by adding Valley Fever to the PRV Program list of eligible diseases, the action could incentivize investment in Valley Fever-related drugs and vaccines through investment in research and development potentially recouped when the FDA approves a Valley Fever product and the PRV is sold.