McCarthy, GOP colleagues seek adding Valley Fever to FDA program to spur drug development

U.S. Rep. Kevin McCarthy (R-CA) led a bicameral, Republican contingent in seeking to have Valley Fever included in a federal disease review program to find a vaccination to treat the rare fungal infection.

“While the scientific community has made important advances in Valley Fever research in recent years, much remains to be understood about this disease, including the fact that rapid diagnostics and treatments are limited and there is still no cure or vaccine,” wrote Rep. McCarthy and his colleagues in a July 26 letter sent to U.S. Secretary of Health and Human Services (HHS) Alex Azar and Acting Commissioner of the U.S. Food and Drug Administration (FDA) Dr. Norman Sharpless.

The lawmakers requested the inclusion of Valley Fever, known as Coccidioidomycosis, on the list of infectious diseases eligible under the FDA’s Tropical Disease Priority Review Voucher (PRV) Program.

Valley Fever, 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, “disproportionately affects the poor and marginalized populations,” according to their letter, which noted that those at increased risk for a severe form of the disease include “persons of African or Filipino descent, pregnant women, adults in older age groups, and persons with weakened immune systems.”

“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,” wrote Rep. McCarthy and members who included U.S. Sen. Martha McSally (R-AZ) and U.S. Reps. Ken Calvert (R-CA) and Paul Cook (R-CA).

By adding Valley Fever to the PRV Program list of eligible diseases, the lawmakers wrote that investment could be spurred in related drugs, vaccines, and research and development.

In May, Rep. McCarthy sponsored the bipartisan Finding Orphan-disease Remedies With Antifungal Research and Development (FORWARD) Act of 2019, H.R. 2858, to support endemic fungal disease research, incentivize fungal vaccine development, and discover new antifungal therapies and diagnostics, according to the bill’s text.

If enacted, H.R. 2858 also would add Valley Fever to the PRV Program.

At the same time, Congress has authorized the HHS Secretary to add to the list of diseases under the PRV program if certain criteria is met and the lawmakers’ letter demonstrates how Valley Fever meets that criteria, according to Rep. McCarthy’s office.