House Minority Leader Kevin McCarthy (CA-23) led a recent bicameral letter to Secretary of Health and Human Services (HHS) Alex Azar and Acting Commissioner of the U.S. Food and Drug Administration (FDA) Dr. Norman Sharpless requesting the inclusion of Coccidioidomycosis, commonly referred to as Valley Fever, in the FDA’s Tropical Disease Priority Review Voucher (PRV) Program.
U.S. Senators Martha McSally (R-Ariz.) and John Cornyn (R-Texas) and Representatives David Schweikert (AZ-06), Ken Calvert (CA-42), Paul Cook (CA-08), Duncan Hunter (CA-52), Doug LaMalfa (CA-01), Tom McClintock (CA-04), Devin Nunes (CA-21), and Rob Bishop (UT-01) joined McCarthy in the letter.
“Drug development is a complicated, time-consuming, and capital-intensive process. This undertaking only becomes that much more difficult when a disease afflicts a smaller population of individuals,” the representatives and senators wrote. “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 so that vouchers can help expedite the development of treatments and preventions of this terrible infectious disease, both here at home and in developing countries in Central and South America.”
Background
Valley Fever is an infectious disease caused by inhaling the spores of a fungus commonly found in the soil of dry areas in the American Southwest, including California’s Central Valley.
In 2018, Kern County recorded 2,992 new cases of Valley Fever—the highest number on record since 1992. Kern County is routinely ranked the second highest in number of Valley Fever cases nationwide, only behind Maricopa County in Arizona.
Under the Tropical Disease Priority Review Voucher Program, if FDA approves a drug or vaccine for a certain neglected disease on the PRV Program list, the manufacturer is awarded a PRV. The manufacturer can apply the PRV to another drug or vaccine approval application at FDA for expedited consideration or sell the PRV to a different drug or vaccine manufacturer, entitling that entity to expedited review by FDA. PRV’s can be extremely valuable as they are used to reduce FDA regulatory approval times and allow products to enter the market quickly.
By adding Valley Fever to the PRV Program list of eligible diseases, the move could incentivize investment in Valley Fever-related drugs and vaccines through investment in research and development that could be recouped when FDA approves a Valley Fever product and the PRV is then sold.
Earlier this year, Rep. McCarthy and his colleagues introduced (H.R. 2858) the Finding Orphan disease Remedies with Antifungal Research and Development (FORWARD) Act of 2019, that aims to combat Valley Fever. Section 6 of this bill would add Valley Fever to the PRV Program legislatively. However, Congress also gave the HHS Secretary the authority to add to the list of diseases under the PRV program if certain criteria is met. The letter demonstrates how Valley Fever meets the criteria under law and regulation to be added to this program.
